655 jobs found in Boston

Job Description Degree Required: University - Bachelor's Degree/3-4 Year Degree - engineering, science, health care or similar required Why is This a Great Opportunity? Our client is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. They are committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. They are currently seeking a Regulatory Affairs Advisor for their Cambridge, MA location.   Job Description Prepare regulatory assessments and plans for new products and design changes. Prepare or direct the preparation of regulatory submissions for product approval/clearance, including 510(k) premarket notifications. Participate in interactions with regulatory agencies needed to obtain product approval/clearance. Support Investigational Device Exemption submissions. Participate on product development Core Teams assisting with regulatory assessments and planning; reviewing product development and clinical protocols and reports to ensure collection of appropriate data for regulatory submissions; and participating in risk assessments and design reviews. Review labeling, training, and promotional materials for compliance with claims and applicable regulations. Assess product and manufacturing changes to determine regulatory impact. Provide ongoing surveillance and analysis of FDA and international medical device regulations for impact on the clients’ products and regulatory procedures. Communicate regulatory requirements to management, Core Teams and others; particularly new and revised regulatory requirements. Develop and maintain regulatory procedures and policies to ensure compliance to applicable regulations. Support US and international product registrations. Support post-market regulatory compliance activities for US and international products Qualifications Education : BS or higher degree in engineering, science, health care or similar required. Experience : 10+ years regulatory experience with at least 5 years regulatory experience in Medical Devices, including demonstrated experience in preparing successful FDA 510(k) submissions. Experience in preparing international submissions is a plus. Experience in acting as a liaison to and communicating with regulatory agencies. Strong working knowledge of FDA medical device regulatory requirements. Knowledge of MHLW, MDD, and other international regulations is a plus. RAC certification is a plus. Skills: Proficient in Microsoft Office. Must possess strong oral and written communication skills.     Company Description We are a Large International Staffing, Recruitment and Executive Search Firm based in Toronto , Ontario but recruit throughout North America, Asia and Europe in all areas of I.T. , Sales and Marketing , Accounting & Finance , Human Resources, Engineering, Manufacturing , Operations and Health Care

Job Description Executive Chef Branded Hotel Seeking dynamic culinary driven leader for hotel transition, with restaurants and banquets RESPONSIBILITIES: * Plans and develops menus for all restaurant and bar concepts * Develops standard recipes and techniques for food preparation and presentation which help to assure consistently high quality and to minimize food costs; exercises portion control for all items served and assists in establishing menu selling prices. * Evaluates food products and defines product specifications to assure that quality standards are consistently attained * Interviews, selects, trains, develops and maintains a professional culinary team sufficient to meet departmental needs * Schedules and coordinates the work of chefs, cooks and other kitchen employees to assure that food preparation quality standards are met within budgeted labor cost goals. * Approves the requisition of products and other necessary food supplies. * Ensures that high standards of sanitation, cleanliness and safety are maintained throughout all kitchen areas at all times. * Manages product costs and departmental labor cost to meet budgetary objectives * Establishes controls to minimize food and supply waste and theft. * Safeguards all food preparation employees by implementing training to increase their knowledge about safety, sanitation and accident prevention principles. * Prepares necessary data for applicable parts of the budget; projects annual food, labor and other costs and monitors actual financial results; takes corrective action as necessary to help assure that financial goals are met. * Consults with the Food & Beverage Director about food production aspects of special events being planned. * Cooks or directly supervises the cooking of items that require skillful preparation. * Ensures proper staffing for maximum productivity and high standards of quality; controls food and payroll costs to achieve maximum profitability. * Interacts with food and beverage management to assure that food production consistently exceeds the expectations of members and guests. * In conjunction with F&B management team, assist in maintaining a high level of service principles in accordance with established standards. * Develops policies and procedures to enhance and measure quality; continually updates written policies and procedures to reflect state-of-the-art techniques, equipment and terminology. * Establishes and maintains a regular cleaning and maintenance schedule for all kitchen areas and equipment. * Provides training and professional development opportunities for all kitchen staff. * Support safe work habits and a safe working environment at all times. * Represent the culinary operations of the concepts through marketing engagements or PR efforts     SKILLS AND ABILITIES * Ability to interact positively with management, coworkers, team members, and the public to promote a team effort and maintain a positive and professional approach. * Ability to produce a high volume of work in a timely manner, which is accurate, complete, and of high quality. * Working knowledge of various computer software programs. * Ability to effectively present information and respond to questions from managers, staff and suppliers Ability to calculate figures and amounts such as recipe proportions, percentage and volume.   QUALIFICATIONS Bachelor's degree (B. A.) from four-year college or university; or 10 years years related experience and/or training; or equivalent combination of education and experience. Minimum 5 years experience as executive chef in a first-class restaurant PHYSICAL DEMANDS While performing the duties of this job, the employee is regularly required to talk and listen while working. The employee is required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch. The employee must occasionally lift and/or move up to 50 pounds. The employee is frequently exposed to high temperatures and fumes. The employee is occasionally exposed to moving mechanical parts, toxic or caustic chemicals, risk of electrical shock, and vibration. The noise level in the work environment is usually moderate. Company Description United Restaurant + Hospitality Group is a network of restaurant and hospitality professionals. Our restaurant, hospitality, and F&B consultants have provided expert recruiting and corporate services to restaurants, hotels, and resorts since 2012. Founder is a Culinary Institute of America graduate and former Sage Hospitality executive. -We are fiercely passionate about your success. -Your business is our business, and your success is our success. We will work with you to optimize operations and identify revenue growth opportunities to make your Restaurant or Hotel Food & Beverage operations profitable. -We are flexible. -Regardless of your size, we will work with you to deliver results-driven service at a fair and at a comfortable cost.

EEO Statement We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law. Duties & Responsibilities The mission of the Harvard T.H. Chan School of Public Health is to advance the public's health through learning, discovery and communication. To pursue the mission, the school produces knowledge through research then translates this knowledge into evidence that can be communicated to the public, policymakers, and practitioners to advance the health of populations. The Office of Research Administration supports the school's mission by serving as a central resource for the research community through the provision of expertise and leadership in obtaining and managing research funds. It acts as the institutional representative of the President and Fellows of Harvard College for the administration of sponsored projects for the school. The Office of Research Administration is comprised of research administrators that work in partnership with faculty to review and submit proposals for funding and to ensure that proposals and then awards conform and are managed according to sponsor guidelines and University policies. The Grants and Contracts Manager will support innovative research at the world's leading public health research institution. Areas of research are focused across nine academic departments which include Biostatistics, Environmental Health, Epidemiology, Genetics & Complex Diseases, Global Health & Population, Health Policy & Management, Immunology & Infectious Disease, Nutrition and Social Behavioural Sciences. The Grants and Contracts Manager is an integral part of the research enterprise and manages the financial portfolios in close partnership with faculty members through the financial management of their research portfolios. Reporting to the Team Lead or Assistant/Associate Director of Finance, they will work with all aspects of pre- and post- award finances, and manage contracts, endowments, and gifts. Faculty have a wide-ranging portfolio of accounts from sponsors including the federal government (e.g. NIH, EPA, DoD), foundations, industry, and international contracts from foreign entities. Some of the grants and contracts are complex and may involve multiple subcontracts and unique deliverable terms. Pre-award responsibilities include : Grant preparation, budget development Application form submission Responding to sponsor requests Senior Grants & Contracts Manager will work directly with the Principal Investigators and will interface with central administrative offices to ensure that the applications meet all university, school and sponsor requirements Other duties as assigned Post-award responsibilities include : Creating budget reconciliation and forecasting reports, and using these reports to meet regularly with faculty to view their financial situations. Reviewing and approving all expenditures Ensuring compliance with requirements such as effort reporting Submitting payroll changes for faculty and staff Timely journal entries as necessary, grant close-outs, etc. Other duties as assigned Basic Qualifications 5+ years of related experience - education may count towards experience. Must have at least 2+ years of financial experience, grants management experience, or experience working in an academic environment; a combination of education and experience may be considered Additional Qualifications Bachelor's degree, and/or Certified Research Administrator (CRA) preferred Experience with Harvard policies and systems (GMAS and Wasabi) preferred Experience working with Microsoft Excel strongly preferred Experience in an academic, hospital, research or related environment preferred Experience working with research faculty on grants and contracts preferred Experience managing training grants, complex awards and working with a variety of sponsors preferred Advanced working knowledge of research compliance issues & of key federal grant regulations preferred Excellent organizational and time management skills preferred Excellent written and verbal skills preferred Outstanding attention to detail preferred Understanding of human subject use, animal use and other research compliance areas preferred Strong problem solving skills preferred Willingness to be flexible and work well with different teams/people preferred PI107002839

EEO Statement We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law. Duties & Responsibilities The mission of the Wyss Institute for Biologically Inspired Engineering at Harvard University is to transform human healthcare and the environment by emulating the way nature builds. Developed as an alliance between Harvard and other premier academic and clinical partner institutions, Institute faculty and staff collaborate in high-risk, fundamental research and science-driven technology development. A major focus of the Institute is to translate the technologies developed by its faculty and staff into commercial products and therapies through collaborations with clinical investigators and establishment of corporate alliances. For more information, visit: http://wyss.harvard.edu/ . As part of the Bioinspired Therapeutics & Diagnostics platform, we are currently seeking a research assistant that will significantly contribute to a research program involving the use of microfluidic in vitro models to study cancer and the role of the stroma and immune response. The successful candidate will also work with our internal drug discovery team to leverage this knowledge to identify and develop novel anti-cancer therapies. He or She will be responsible for the optimization and execution of microfluidic Organ on Chip primary cell culture and the development and validation of various in-vitro cell based assays, including, but not limited to cell based qPCR/TaqMan, ELISA, westerns, enzymatic assays, imaging, and flow cytometry. Previous knowledge of intestinal and/or esophageal epithelial and/or immune cell culture, as well as IPS technology, is a plus. Previous experience with mammalian cell culture is a must. The candidate will be expected to work independently under the supervision of staff and faculty to design experiments, learn new skills, troubleshoot, and to contribute intellectually to the project.In addition, the candidate is expected to order supplies, perform support activities and lab maintenance, and function in a team-oriented environment with other scientists and staff at the Institute. The candidate will participate in the preparation of manuscripts and patent applications. Under the supervision of staff, the candidate may present data and conclusions at meetings within the Wyss Institute. Basic Qualifications Bachelor's degree in Cell Biology, Bioengineering, or related field. At least two years of experience involving aseptic mammalian cell culture and molecular biology techniques, such as ELISA, PCR, microscopy or related experience. Education may count towards years of experience. Additional Qualifications Bachelor's degree in Cell Biology or Bioengineering preferred. Candidates with experience in multiple primary cell types, specifically lung and immune, will be strongly considered. Experience with cell culture in microfluidic device is a plus. Ability to work well independently and to collaborate with a multidisciplinary group is essential. The candidate should be proficient with personal computers and applicable software packages (Microsoft Office). Good written and oral communication skills are essential. The candidate should be highly motivated, detail-oriented, organized, and able to take initiative. PI107002870

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15163 Job Category: Clinical Operations Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Position Summary This position is accountable for the timely delivery of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will lead the medical writing activities across a disease area or set of clinical programs. The scope of this position includes the management and oversight of clinical study protocols, Investigator's Brochures, clinical study reports, and collaborate on smaller scope regulatory submission documents, risk management plans, briefing documents, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents with minimal supervision. Job Duties & Responsibilities Develop and implement clinical document strategy for clinical documents, including clinical study protocols, clinical study reports, Investigator's Brochures and updates, smaller scope regulatory submission documents (includes Module 2 summaries), risk management plans, contributions to briefing documents, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents, working cross-functionally and with minimal supervision. Manages the writing and completion of documents and other assigned tasks within established timelines (editing and QC) and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Actively supports clinical project team(s), representing Medical Writing and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary. Participates with other medical writing team members to formulate writing strategies and standards to be implemented and takes responsibility for execution. Develops effective collaborations with other functional lines in Alexion, and externally with regulatory, industry, professional, and academic organizations Ensures consistent support and implementation of medical writing standards Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensures adherence to standards. Ensures that all activities are conducted in compliance with relevant regulatory requirements. Partners with Scientific Communications to support clinical trial results, publication activities, and scientific presentation and promotional material for assigned projects Maintains adherence to uniform processes and stands in partnership with statistical, clinical, regulatory and pharmacovigilance colleagues. Essential Qualifications BS degree in life sciences or equivalent required At least 5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge Proven excellence in operational strategy; experience with developing, implementing, and measuring the impact of medical writing processes and systems across multiple projects Experience desired in medical writing for ultra-rare diseases and capability to develop and implement innovative solutions for optimizing medical writing for ultra-rare disease studies Thorough knowledge of global regulatory requirements and ICH/GCP guidelines is essential Ability to establish excellent internal and external relationships; including alliance partners and vendors Excellent Project Management and administrative skills Excellent oral, written, and presentation skills Excellent problem solving, organizational, and negotiating skills Experience with adult and pediatric clinical research in various therapeutic areas Well-developed sense of ethics, responsibility and respect for others Thrives in a team-based environment Results-driven and sets standard of excellence for self and others Fast learner and ability to work independently while seeking advice as required Demonstrates an entrepreneurial energy and enthusiasm which brings a positive approach to all challenges and fosters the idea that nothing is impossible High level of flexibility and ability to innovate and adapt to changing conditions Preferred Qualifications Advanced degree in a relevant scientific/clinical/regulatory field preferred Experience with global trials and regulatory submissions preferred Experience with partnering and managing CRO relationships a plus Experience with ultra-rare disease and Orphan Drug clinical research is highly desirable Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107003784

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15165 Job Category: Clinical Operations Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Position Summary This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will support the medical writing (WM) activities for one or more clinical programs. This position will function with moderate supervision. The scope of this position includes the writing, document management, and development support for clinical study-related documentation including, but not limited to, clinical study protocols, Investigator's Brochures, and clinical study reports; and to collaborate with cross-functional teams to write and development other IND/CTA or global regulatory submission documents. Job Duties & Responsibilities Authors or provides authoring support for clinical documents and other assigned tasks within established timelines, with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Clinical document types include clinical study protocols, clinical study reports, Investigator's Brochures and updates, and other IND/CTA or global regulatory submission documents Supports development and implementation of strategy for writing and completion of high quality clinical documents Manages the writing and completion of documents and other assigned tasks within established timelines (editing and QC) and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Actively supports clinical project team(s), alone or in collaboration with other MWs, and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary. Participates with other MW team members to develop and support process and standards to be implemented, and takes responsibility for execution across cross functional teams. Maintains adherence to uniform processes and standards in partnership with statistical, clinical, regulatory, and pharmacovigilance colleagues. Develops effective collaborations with other functional lines in Alexion. Ensures consistent support and implementation of MW standards. Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensures adherence to standards. Ensures that all activities are conducted in compliance with relevant regulatory requirements. Essential Qualifications MS degree in life sciences or equivalent required 3-5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge Demonstrated writing capability for scientific or clinical documents, (eg, clinical study protocols and clinical study reports, Investigator's Brochures Excellent oral, written, and presentation skills Demonstrated project management, problem solving, organizational, and negotiating skills Agile learner and ability to work independently while seeking advice as required Familiarity with global regulatory requirements and ICH/GCP guidelines Ability to establish excellent internal and external relationships, including alliance partners and vendors Thrives in a team-based environment Results- and compliance-driven and sets standard of excellence for self and others Well-developed sense of ethics, responsibility, and respect for others High level of flexibility and ability to innovate and adapt to changing conditions Preferred Qualifications Advanced degree in a relevant scientific/clinical/regulatory field preferred Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107003819

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15168 Job Category: Clinical Development Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Position Summary Seeking an individual who is Board Certified in Internal Medicine with 3-5 years of industry experience. This individual will serve as a medical expert for the study team and medical monitor for phase 2-4 clinical trials. This position additionally offers substantial opportunities for regulatory and commercial interactions and career advancement in the fast-moving area of rare disease. Job Duties & Responsibilities Medical Expert for clinical study team Protocol development from concept to final protocol Strategic guidance to phase II/III development programs and oversight of global clinical trials/trial team (s) on assigned program(s) Presentation at academic congresses, investigator meetings and advisory meetings Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents DMC development and liaison Medical oversight of commercial documents Essential Qualifications MD or equivalent Board Certified in Internal Medicine or Neurology Minimum 3-5 years of industry experience Previous history running clinical trials Safety medical monitoring and reporting experience Protocol development experience Regulatory experience Basic statistical knowledge Excellent written / oral communication skills Ability to think strategically Willingness to take on new responsibilities Interest in career progression and ability to take on a more senior roles in 1-3 years Preferred Qualifications Subspecialty certification History of academic clinical or basic science research Business development experience Publication in peer reviewed journals Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107003855

W.B. Mason Company, Inc. Equal Opportunity Employer W.B. Mason Company, Inc. is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status. Requisition ID 2019-2419 Job Locations US-MA-Boston Position Type Full Time Shift Type First Shift Category Distribution/Transportation/Warehouse Overview The Picker will help process and receive store products and will pick orders specific to customer's orders. Responsibilities Essential Duties and Responsibilities Reads customer orders to determine items to be moved, gathered, or distributed. Accurately selects items to be pack as per order ticket. Other duties as assigned. Knowledge, Skills and Abilities Must pay attention to detail and demonstrate accuracy and thoroughness. Must regularly lift and or move 75lbs or more. Must possess outstanding communication skills. Must be able to multi-task and work in a fast-pace environment. Ability to converse, read and write in English. Qualifications Minimum Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to stand, walk, speak and hear. The employee is frequently required to sit. The employee must regularly lift and/or move up to 75 pounds. PI107003681

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15192 Job Category: Clinical Development Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Job Summary The Associate Director, Clinical PK-PD is responsible for providing clinical pharmacology input in early (up to proof-of-concept stage) and late-stage clinical development. The incumbent will be responsible for representing clinical pharmacology function on drug development teams, providing input on the dose and the design of early and late-stage clinical trials, and for interacting with the clinicians and the clinical operations group for the execution of the clinical pharmacology components (PK, PD, biomarkers, etc) of the trials. In addition the incumbent will be responsible for performing clinical PK/PD analyses, for providing subject matter leadership related to clinical ADME, pre-clinical to clinical extrapolation and selection of dose/regimen during early development. Additionally, the incumbent will be responsible for providing input on study design and leading the selection of doses for late-stage clinical studies. The incumbent will contribute to the preparation of the regulatory documents such as briefing books for pre-agency meetings, IBs, INDs, and IMPD dossiers, protocols, and clinical study reports. The incumbent will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. The incumbent will be responsible for working within the department level budget and resources. Support technical due diligence efforts for business development. Willingness to relocate near Alexion US R&D location (Boston, MA) and to travel approximately 10 % of the time. Principal Responsibilities Responsible for providing support for the preparation of the clinical pharmacology (PK, biomarkers, Bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, M&S plans Contribute to the preparation of the pre-IND, IND, IB and IMPD documents Responsible for the pharmacokinetic and PK/PD data analyses using WinNonlin, NONMEM and/or other softwares Contribute to the design of early phase clinical trials (FIH to POC) and support project goals Responsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC Contribute to the design of late-stage clinical trials (POC-BLA/NDA) and support project goals Responsible for leading the recommendation for the starting dose in Phase II and III clinical trials based on PK, PD biomarker and efficacy data analysis from previous studies. Responsible for the preparation of the PK/PD reports and clinical study reports Represent Clin Pharm function for the project team at the regulatory agencies during regulatory meetings. Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions. Qualifications Doctoral degree (PhD or national Equivalent) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant discipline. Around 5-10 years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry. Exposure to biologics drug development. Knowledge of basic and clinical immunology is plus. Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data Knowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA and EMA Excellent written and oral communication skills including good presentation skills Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using WinNonlin, NONMEM and potentially, other data analysis software. Experience with performing allometric scaling and making prospective dose/regimen recommendations for planned Phase 1, 2 and 3 trials. Experience in preparing clinical pharmacology components of clinical study protocols and clinical study reports. Knowledge of current practices and issues in the bioanalytical and drug metabolism areas Proficient in the use of Microsoft Word, Excel and Powerpoint Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107004106

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15169 Job Category: Project Management Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Position Summary The Project Manager is the operational leader for the global development program / early development projects and provides global project management support to the Global Development Team / Early Development Team. The GPM is responsible for management and delivery of the integrated development plan, encompassing the strategy for the medicine across indications and ensuring alignment across strategic/operational/tactical plans, in support of the overall objectives and priorities of the program. The GPM is the leader of the Operational Sub-Committee of the Global Development Team or equivalent forum on Early Development Team and manages the operational plan and deliverables of the project so that they are achieved on or ahead of schedule, on budget, and support the target product profile, business deliverables, and/or key decision required. Principal Responsibilities Project Strategy Drives development of global project level goals that contribute to the overall goals of R&D. Leads the development of an Integrated Development Plan, encompassing the overall R&D strategy for the medicine and ensuring alignment between the overall product vision, strategy, and goals. Drives decision point planning and the associated deliverables across all functions of the team and contributes to the R&D strategy planning process for the project. Leads decision analysis with the team including development and assessment of outcome scenarios and alternative development options, robust go/no go decision criteria, probability of technical and regulatory success, value, and investment implications. Consistently assesses program and project-level strategy relative to the overall R&D portfolio prioritization to ensure an appropriate balance between project priority and resource consumption. Proactively recommends and drives the operational plan and resource adjustments to improve productivity and return for the program. Project Management Drives development of the global project level goals that contribute to the overall objectives for the R&D portfolio. Monitors and reports on progress of the program goals. Leads generation and alignment of a Global Integrated Development Plan across functional lines. Drives milestone decision point planning and associated deliverables across functions to achieve the overall program objectives. Clearly defines the critical path and generates clear decision criteria for the project. Prepares and manages governance interactions in partnership with the Team Lead. Leads the process for evaluation of alternative development options to operationally deliver plan. Influences and drives development of solutions, criteria, and implications. Partners with team functional leads/delegates to 'pressure-test' assumptions and integrate planning across development into the overall project plan, (e.g. Medical Sciences, Regulatory, Clinical Operations, Biostatistics, Technical Operations, Commercial, Global Medical Affairs (GMA), Toxicology, Research functions, etc.). Defines the interdependent deliverables and ensures that quality, risk, cost, time are managed within the overall approved plan to drive delivery of project milestones and objectives on time and on budget. Partners with the Project Planner to ensure that project schedule, resource management and project controls are established and maintained. Key contributor to well-planned and negotiated transitions of projects from Research to Development to Commercial. Manages an integrated project budget and resource plan in partnership with the Team Lead, Finance team member, and functional line representatives on the team. Works in close partnership with the R&D Portfolio Lead to ensure alignment of project goals and objectives within the portfolio, and provides project information and context necessary to support portfolio review, investment decisions, and prioritization. Project Resource Management Leads and negotiates project-level budgets and resource plans on behalf of the team. Proactively manages the project budget and resource demand including investment buy-ups/buy-downs in partnership with the Team Leader, Finance, and Functional lines. Manages against an approved budget and resources for the project to ensure it is in alignment with the overall R&D budget. Partners with Finance to actively manage the project budget to plan, pressure test and align assumptions in the forecast, ensure transparency and understanding of the approved plan, funding status of activities, and identify potential efficiencies with the team. Ensures that cross-functional process efficiencies are identified and maximized in accordance with the Team's project goals. Project Execution and Delivery Leads the Operational Sub-Committee of the Global Development Team and the equivalent forum in early development teams. Works in collaboration with team members to manage the project to achieve key milestones according to the endorsed plan and time, cost and quality parameters. Influences leadership across functional lines to ensure efficient delivery of the project. Negotiates the allocation of line resources to support the endorsed integrated plan. Drives execution of the project in a manner that achieves delivery performance goals/objectives and the agreed plan without compromising project deliverables or relationships. Engages robust project management skills to drive projects to key decision points and milestones. Proactive management of the critical path, operational feasibility of strategic plans, active identification and management of project risk, and alignment of operational execution. Leads the identification of operational and project/program issues for discussion with appropriate Team Leadership. Drives resolution across the team through options assessment, effectively documenting decisions and the rationale. Monitors and manages progress against the approved budget including acceleration and staging opportunities. Manages the project schedule, budget, and resource information, investment options to enable efficient and effective R&D portfolio management. Leads operational project management for alliance co-development programs, including contributing roles on alliance sub-committees and steering committees. Plays a leadership role in partnering with Finance to manage the alliance budget forecast and asset valuation assessments. Project Risk Analysis and Management Leads the team in the preparation, implementation and maintenance of integrated project level risk management plans including risk identification, assessment, and action plan with negotiated trigger criteria, resource requirements, and impact. Leads the assessment of project risk (technical and regulatory success and operational) in collaboration with the Team Lead, R&D Functional Lines, Technical Operations, Commercial, Legal, and other functions. Partners with the team to identify contingency and risk mitigation strategies for project/program level plans and negotiates the preferred team option to achieve this most rapidly for the lowest cost while maintaining acceptable quality. Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications assessment (value, risk, cost, time) to the overall drug development approach, approval strategy, and launch. Information & Communication Management Responsible for development and management of the communication plan for the program, including stakeholder management. Defines and aligns project messages and major communications (internal and external) with the Team Leader and team. Responsible for ensuring effective, accurate and timely communication of project information in order to facilitate development of action options and team recommendations to governance. Responsible for ensuring effective, accurate and timely communication of project information. Effectively communicates project issues and opportunities. Identifies team performance issues and partners with the Team Leader to recommend and develop appropriate action. Qualifications 10+ years of experience managing and leading multiple complex projects/programs of relevant experiences within the biopharmaceutical industry. Demonstrated success in leading and negotiating in a matrix-based organization. Empowering leader who engages others to take ownership of projects and drives decisions that achieve shared goals through teamwork. Must be able to create a highly collaborative and inclusive environment necessary for the team to be effective. Strong track record in executing effective project management in cross-functional drug development teams or clinical, regulatory, medical functions, pharmaceutical sciences/technical operations in the biopharmaceutical industry. Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality, and risk management to teams. Demonstrated results in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and fiscal awareness. Demonstrated ability to effectively implement the tools and techniques of the project management discipline, such as the development and management of multi-disciplinary program level integrated operational plans, critical path management, project risk management, decision analysis and meeting management. Extensive pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and regulatory interactions. Proven track record of achievement and delivery for personal and team goals. Knowledge of commercial issues that impact project/product strategy and planning. Education Bachelors' degree in business or scientific discipline Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107004071

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15159 Job Category: Clinical Operations Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Position Summary The Senior Manager, Clinical Project Lead is accountable for the study team and study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors. The Senior Manager will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance. The Senior Manager, CPL will provide status updates and performance metrics and develop, review and approve related study documents. Job Duties & Responsibilities Under direct supervision of the Director CPL or Franchise Head, is accountable for the planning, implementation and execution of clinical trials, including study deliverables, milestones and data quality. Leads the Clinical Trial Team. Management oversight of CROs and relevant study vendors. Reports to the Director CPL or Franchise Head on trial metrics, issues, and rescue activities. Manage CRO relationships to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget and quality Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection. Manage clinical study budgets within agreed variance. Communicate clinical studies performance data to other members of the management and scientific team. Prepare and maintain required study and regulatory documentation, e.g., reports for Competent Authority submissions, template informed consent, Monitoring Plan, Pharmacy Manual, investigator contracts and budgets. Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report. Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices. Participate in and/or lead departmental initiatives. Essential Qualifications >5 years of clinical research experience, 3 of which in a leading role accountable for the planning and execution of global clinical trials. Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development. Preferred Qualifications PMP certification desirable. Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107004248

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15196 Job Category: Clinical Development Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Position Summary Director PK-PK Modeling and Pharmacometrics (PMX) position is responsible, as a PMX project leader, for developing and executing Modeling&Simulation (M&S) plans and strategies and exposure response analyses for compounds from the early stage (first-in-human up to proof-of-concept) to the late-stage clinical development (proof-of-concept up to post market) in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology, Translational Medicine, Medical Sciences, Biostatistics, Research and other colleagues within Alexion R&D organization. This position will play a key role in strengthening the PMX and Modeling capability within Alexion by strongly contributing to the continuous improvement of pharmacometric technical skillset, computational infrastructure and the strategic use of M&S methodologies across our projects and disease areas, and optimizing the utility of external PMX resources. This position will also be responsible for his/her project related M&S assignments either executed independently (about 50%) or in collaboration with external PMX CROs (about 50%). This position will 1) Develop and execute population PK, PKPD, exposure response, dose selections for phase 3 strategies/plans and corresponding models for the pharmacometric function from early clinical studies to Phase IV studies 2) Develop the quantitative system pharmacology strategies/plans and corresponding models for target identification, and compound design/characterization, translation from preclinical to FIH dose selection; The incumbent will be responsible for the preparation of population PK/PD reports and corresponding regulatory submission documents. The incumbent will be expected to manage multiple development projects simultaneously, and will participate in discussions and presentations to senior management. Principal Responsibilities As M&S project lead in one or more cross functional development teams, develop and execute M&S strategies/plans fully integrated with the overall preclinical and clinical plans; By using state of the art M&S methodologies strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with Biostats, Clin Pharm, Medical Sciences, Research, and other quantitative disciplines; Lead an internal matrix team(s) in building quantitative systems biology/pharmacology (QSP) models to support the activities from early discovery to FIH and beyond, in collaboration with leading external QSP service providers; Perform population PK, PKPD-analyses, clinical trial simulations and other model based analyses when appropriate; Initiate and coordinate outsourced M&S activities on a regular basis; Mentor and coach junior M&S scientists and junior clinical PKPD scientists; Strengthen and build Alexion internal M&S capability on a continuous basis by initiating training activities, evaluating and introducing new M&S tools and computing platform as appropriate; Prepare population PK/PD reports and corresponding regulatory submission documents. Qualifications Ten+ (for director) or 6+ (for associate director) years pharmaceutical industrial experiences in the related disciplines of clinical pharmacology, PKPD, and QSP; Excellent hands-on knowledge in R, S-PLUS and/or SAS, NONMEM; Excellent knowledge in Mathlab, or other QSP related softwares or computing platform; Well versed at plotting complex data to identify trends important for drug development; Track record of applying quantitative system pharmacology methodologies in a drug R&D context; Track record of contributions to INDs, NDAs/BLAs, and various regulatory submissions; Track record of publishing M&S work Managerial experience, especially related in CRO personnel management is preferred; Experience from pharmacometric approaches in hematology, nephrology, metabolic, and neurological disorders and rare diseases preferred; Exposure to rare disease drug development is desired Excellent written and verbal communication skills Education A PhD, degree or equivalent in quantitative sciences, background in engineering, or clinical pharmacology is desired. Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107004125

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15158 Job Category: Clinical Operations Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Position Summary The Associate Director, Clinical Project Lead is responsible to lead the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility and budget and timeline estimates and operational accountability and management of study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors. The Associate Director will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance. The Associate Director, CPL may be accountable for setting and managing operations across multiple studies and may be a member of the Core Team depending on the scope of the project. Job Duties & Responsibilities Accountable for the planning, implementation and execution of pivotal clinical trials, including study deliverables, milestones and data quality. Leads the Clinical Trial Team. Management oversight of CROs and relevant study vendors. Oversee third party vendors to operationalize these study specifications. Directs the operational execution of clinical study activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity; and patient protection. Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals. Manages CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget. Communicates clinical studies performance data to other members of the management and scientific team. Prepare and maintain required study and regulatory documentation, e.g.:, reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements and budgets. Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report. Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices. Participate in and/or lead departmental initiatives. Essential Qualifications >10 years of clinical research experience, 5 of which in a leading role accountable for the planning and execution of global clinical trials. Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development. Ability to lead cross-functional teams and to provide management oversight of CROs. Experience in developing study budgets, forecasting and financial oversight of a project. Preferred Qualifications Advanced degree (Master, PhD, MD) is desirable. PMP certification desirable. Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107004188

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15160 Job Category: Clinical Operations Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Position Summary Assist the CPLs for the planning, implementation, execution and compliance of operational plans for clinical study/program with multiple clinical vendors in order to maintain inspection readiness. This is a tactical position and involves protocol execution at the site level via established vendor oversight and escalation pathways. Serve as a peer mentor for staff, as needed. Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted. Depending on the program scope, the CTM II may have study level responsibilities similar to any other CTM. Job Duties & Responsibilities Customize/update any study-specific plans and process flows for multiple clinical vendors, as appropriate e.g., TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release plan etc. Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted. Assist CPL by tracking compliance to all study level plans and escalating any variances. Serve as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF). Ensure CRA compliance with the study parameters via review of monitoring visit reports. Track escalation and closure of action items noted in the monitoring visit reports. Ensure registration of a protocol in ClinTrials.gov/EUdract and monitor its update throughout a study's life cycle for compliance with the regulations and SOP. Act as central point of contact for vendor providing this service. Assist CPL with Interactions with CRO and site staff to adhere to study budgets. Requests accruals, and performs contract and invoice review. Participate in operation meetings with CRO, and cross-functional team members; document escalations and actions. Coordinate study team training in the investigator portal; monitor site/CRA user access and track compliance during the study. Coordinate with CPL and cross-functional team to assemble study documents as appendices for CSR at study close-out. Upon site closure, prepares subject files, inventories documents, reconciles document discrepancies, and organizes study files for electronic archive and off-site storage. SME for initiatives in conjunction with the CoE, as required to ensure consistent implementation of best practices across all studies and within a franchise. Essential Qualifications >3 years of clinical research experience, in the pharmaceutical industry with a solid understanding of technology and processes used in drug development. Work with CROs and vendors to drive timelines and deliverables. Experience working with study budgets and forecasting; contract and invoice review. Preferred Qualifications Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development. Research certification desirable. Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107004214

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 15167 Job Category: Clinical Development Location: Boston, MA Posting Date: January 16, 2019 Attention: If you are a current Alexion employee, please apply via Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Position Summary Seeking an individual who is Board Certified in Internal Medicine with 3-5 years of industry experience. This individual will serve as a medical expert for the study team and medical monitor for phase 2-4 clinical trials. This position additionally offers substantial opportunities for regulatory and commercial interactions and career advancement in the fast-moving area of rare disease. Job Duties & Responsibilities Medical Expert for clinical study team Protocol development from concept to final protocol Strategic guidance to phase II/III development programs and oversight of global clinical trials/trial team (s) on assigned program(s) Presentation at academic congresses, investigator meetings and advisory meetings Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents DMC development and liaison Medical oversight of commercial documents Essential Qualifications MD or equivalent Board Certified in Internal Medicine or Neurology Minimum 3-5 years of industry experience Previous history running clinical trials Safety medical monitoring and reporting experience Protocol development experience Regulatory experience Basic statistical knowledge Excellent written / oral communication skills Ability to think strategically Willingness to take on new responsibilities Interest in career progression and ability to take on a more senior roles in 1-3 years Preferred Qualifications Subspecialty certification History of academic clinical or basic science research Business development experience Publication in peer reviewed journals Boston, MA, United States Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com . As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion participates in E-Verify process. To learn more, please click on attached document(s) English / Spanish PI107004032

Analysis Group Locations US-MA-Boston Overview Analysis Group is one of the largest economics consulting firms, with more than 950 professionals across 14 offices in North America, Europe, and Asia. Since 1981, we have provided expertise in economics, finance, health care analytics, and strategy to top law firms, Fortune Global 500 companies, and government agencies worldwide. Our internal experts, together with our network of affiliated experts from academia, industry, and government, offer our clients exceptional breadth and depth of expertise. The Network Security Engineer assists in maintaining the security of Analysis Group's network infrastructure. In addition, the Network Security Engineer is responsible for related operational activities, such as the configuration, installation, monitoring, maintenance, upgrading, patching and associated troubleshooting of Analysis Group's systems. This position is also responsible for analyzing and resolving identified vulnerabilities and security incidents in a timely and accurate fashion, and provides end user and IT security training where required. Essential Job Functions and Responsibilities: Conduct internal vulnerability and security scans of Analysis Group's network infrastructure (i.e. databases, operating systems, network devices, etc.) Manage and review external vulnerability scans conducted by Qualys Conduct subsequent analysis of scan results to assign overall risk levels to systems Work independently and with various IT teams to mitigate identified vulnerabilities based on applicable risk Review and analyze vulnerabilities that have been identified as being required for functionality; and develop mitigation plans Provide technical guidance and hardening recommendations for new systems currently in the design phase Attend and support infosec related system design reviews and other technical meetings Develop scripts to simplify data collection that are necessary to occur throughout the scanning and vulnerability assessment process Work with third parties to conduct yearly external penetration testing of critical systems Evaluate the latest vulnerability, network discovery, penetration, and other security evaluation tools Manage and maintain Dell Secureworks Managed SEIM platform, on board new systems, monitor and manage alerts through to resolution Research, recommend, implement and manage solutions to improve our logging capabilities in areas such as CIFS logging, IDS/IPS, firewall, AV, log aggregation and reporting Research, recommend and implement solutions to constantly improve the firms overall security posture Assist with the completion of various client security assessment questionnaires Qualifications: University degree in computer science or electrical engineering and 5+ years equivalent work experience Information Assurance Certifications (i.e. CISSP, CISA, GIAC, Security +) Excellent verbal/written communications skills Firm understanding of Windows and Linux system administration and security Network vulnerability scanning and remediation Demonstrated knowledge of SEIM and logging solutions. Operating systems: Windows, Unix, Linux Vendor-Specific Certifications (i.e. MCITP, CCNA, SCSA) Familiarity with regulations and standards such as PCI, NERC/CIP, SOX, HIPAA/HITECH, FFIEC, EU Privacy Laws, ISO, COBIT, NIST SP800-92, NIST SP800-94, NIST SP800-53 Patching tools such as Altiris or Kace Scanning and evaluation tools: Nessus, Qualys, Wireshark, NMAP, etc. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. Please view Equal Employment Opportunity Posters provided by OFCCP here . The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) PI107000795

Analysis Group Locations US-MA-Boston Overview Analysis Group is one of the largest private economics consulting firms, with more than 950 professionals across 14 offices in North America, Europe, and Asia. Since 1981, we have provided expertise in economics, finance, health care analytics, and strategy to top law firms, Fortune Global 500 companies, and government agencies worldwide. Our internal experts, together with our network of affiliated experts from academia, industry, and government, offer our clients exceptional breadth and depth of expertise. This position manages the introduction of a number of enhancements to Finance systems and provides additional depth and backup for the Finance team. This position will provide in-depth financial analysis and additional bandwidth to accomplish future implementations, projects, and team goals and provide back up and redundancy for the finance functions as needed. Essential Job Functions and Responsibilities: Client Finance Process – Oversee compliance in the work flow process for all Client Finance functions. Review compliance with AGI's policies and procedures with an eye towards monitoring client and process risks Billing – Oversee and provide a high level of support and back-up for the Billing Managers. Address billing issues and concerns with a high level of urgency and skilled customer support. Collections – Oversee and provide a high level of support and back-up for the Collections team. Employee Utilization/Time Reporting Analysis – Work with all employees to ensure time entry is completed on a monthly basis. Generate, proof, and review monthly utilization reports. Prepare reports for review and distribution. Case Related Profitability Reporting – Generate, proof, and review monthly profitability reports. Prepare reports for review and distribution. Reporting and Analysis – Independently respond to all requests for analysis of time or billing information and statistics. Review and analyze financial reports for senior management Special Projects – Manage own time and outside resources through completion of special projects assigned. Ensure all deadlines are met. Internal Client Relations – Build strong relationships with the consulting and administrative staffs. Provide high quality service and support. Advise staff regarding the handling of non-routine billing requests Exhibit accuracy, detail, and quality assurance in all work. Other Responsibilities – Support and back-up for the Controller, Billing functions, and Collections functions. Direct reports – Billing Manager, Accounts Receivable/Project Manager, including the collection team and Billing Coordinators. Responsible for conducting performance reviews. Monitor and analyze department work to develop more efficient procedures and use of resources while maintaining a high level of accuracy Collaborative Initiatives: Work with external accounting and auditing firms on revenue recognition, billing matters and receivable analysis Work closely with company's legal and compliance staff on client-related questions Collaborate with department's financial systems manager on maintaining and upgrading billing related reports and other ad hoc report development Qualifications: Bachelor's degree in Finance or Accounting is preferable. MBA, CPA, or other advanced professional would be a plus. Minimum of 10 years of experience in a professional services company environment. Minimum of 5 years of experience in a managerial role. In-depth expertise of accounting and billing software is required. A working knowledge of SQL would be a positive Strong analytical experience and problem solving capabilities is a must Demonstrates technical competence and effectively delivers support in area of expertise. Communicates, written and orally clearly and concisely. Effectively listens to requests. Works effectively with others and independently. Demonstrates initiative and ownership. Resolves problems quickly and effectively. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. Please view Equal Employment Opportunity Posters provided by OFCCP here . The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) PI107000811

EEO Statement We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law. Duties & Responsibilities The Research Assistant III (RA) will support one faculty member coordinating and carrying out research projects, focused on data programming and statistical analysis, while also contributing to reviewing the literature, drafting material for manuscripts, and overall project management. The most important work of the Research Assistant will be to use statistical software to analyze large datasets, including insurance claims datasets. This work will involve examining and cleaning datasets, merging and organizing data files, creating data sets that can be analyzed, and using statistical methods (under faculty supervision) to analyze the datasets. A strong background in statistical programming is required (STATA necessary, both STATA and SAS encouraged). A conceptual and working understanding of economics and econometrics is strongly encouraged. The Research Assistant will also be expected to have strong analytic skills to interpret findings of the data analyses, think through limitations of the data analyses, and design sensitivity analyses to test the robustness of findings. The Research Assistant will also contribute to the development of manuscripts and presentations. This will include conducting literature reviews, drafting portions of manuscripts related to the data analysis, and creating presentation slides with findings from the analyses. The Research Assistant will participate in team meetings and be expected to work in a collaborative and supportive manner with other members of the research team. Relatedly, the Research Assistant will help support the faculty member with project management, such as IRB applications and data compliance tasks. Basic Qualifications Three or more years related research experience. Applicant should have proficiency in using statistical software packages such as STATA. Higher education may count towards experience. Additional Qualifications Bachelors degree preferably in the field of a specific research study, with a preference for coursework in a social science field (economics, statistics, or sociology with a quantitative focus). Must demonstrate interest, experience, or background in the area of health policy and/or health services organization, financing, and delivery. Must be proficient with most computer software including Word, Excel, and Powerpoint. Must have a working knowledge of statistical software, in particular, STATA. Competency with LaTeX preferred. Must learn other software as needed. Independent judgment, patience, and excellent communication skills are required to respond effectively to varied/complex tasks. Organizational skills and attention to detail are required. Flexibility and an ability to work with a team are essential. Must be able to maintain a calm and cooperative attitude during periods of increased staff activity. PI107002730