1,143 jobs found in Boston

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16142 Job Category: Global Medical Affairs Location: Boston, MA Posting Date: July 22, 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 Director of Global Health Outcomes Medical Value Assessment should be accountable for the strategic development of the Health Outcomes Plan and the development and update of the Clinical Value Dossier for Alexion. The person should work closely with cross-functional partners throughout Alexion and local markets to develop and execute on the Health Outcomes Plan, pricing and reimbursement strategies and treatment recommendations with local agencies and through local physician experts. Principal Responsibilities Work with the cross-functional partners to develop health outcomes studies to demonstrate the value of the specific of Alexion Therapeutics Work with Director Global Health Outcomes Research to develop the global clinical value dossiers that provides the medical value proposition of Alexion products and advances the disease understanding aimed at payors and national pricing and reimbursement agencies. Work closely with Global Government Affairs and local Medical affairs to draft and review the medical evidence and clinical data of Alexion therapeutics to address health pricing and reimbursement agencies request for information. Work cross functionally with Scientific Communications and to request and review recent clinical data and literature to ensure medical value of Alexion therapeutics are well communicated. Work cross functionally with Commercial and Medical Information providing therapeutic area expertise to ensure medical value of Alexion Therapeutics is well communicated. Work cross functionally with National Accounts providing therapeutic area expertise to ensure medical value of Alexion Therapeutics is well communicated to payors Work with local physician working groups to build presentations on disease education and clinical data of Alexion Therapeutics Qualifications Background in health outcomes research, market access, health economics, phase IV clinical trials, health policy, and health services research preferred. Minimum of Master's degree with 5 years of experience in the biopharmaceutical or pharmaceutical industry; for those with a doctoral degree, 2 years minimum experience. Understanding of the global market access landscape and of the evolving US health care environment required. Knowledge of the drug development and commercialization process and an understanding of the field of Health technology Assessment. Strong leadership skills and comfort operating in a matrix; prior people management experience preferred. Education Advanced degree in a biomedical field required. MD, PhD, PharmD (with experience in epidemiology, economics, public health policy, econometrics, pharmacoeconomics, psychometrics, and health services research) preferred. Minimum of 10 years of experience in the biopharmaceutical industry required. MPH, MBA with a science background (Must have 15 years of relevant experience as above). *LI-MW1 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 PI112199782

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16140 Job Category: Clinical Operations Location: Boston, MA Posting Date: July 22, 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 (CPL) is responsible for and manages study deliverables through internal and external resources and is the primary point of contact and interface between these functional groups, investigator sites and vendors. The CPL will drive continuous improvement of processes and sharing of best practices in clinical research. He/she will also ensure inspection readiness and compliance for the study team, CRO, vendors and investigator sites. Responsible for leadership and management of the clinical study team, focusing on proactive management of patient safety and data integrity. Responsibilities include design, execution and reporting of studies; drives the definition of the scope of work, selection, management and oversight of CROs and vendors; approves selection of clinical trial sites. Provides status updates and performance metrics to senior management. Leads the development, review and approval of all study documents. Principal Responsibilities Direct the creation and execution of clinical trial activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practice (GCP). Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection. Lead cross functional clinical study team to achieve study milestones. Interact with internal and external groups to achieve study milestones. Determine study requirements, define specifications, and initiate and lead the selection of third party vendors. Manage CRO relationship 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 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. May provide input into the clinical development strategy for assigned study including but not limited to operational feasibility, budget and timeline estimates. May participate in and/or lead department initiatives Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices. Qualifications A solid clinical operations professional with at least 5 years' experience in clinical research. Must have proven technical leadership skills. Individual must have cross-functional clinical expertise for effective problem solving and successful execution of the clinical plan for a study that includes site management & monitoring, drug supply, data management, medical monitoring, biostatistics, medical writing, drug safety, and regulatory affairs. Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization. Knowledge of team development principles and successful implementation of the same is desirable. Effective management and oversight of CROs plus a track record of ensuring GCP compliance and risk management of clinical studies is expected. Excellent interpersonal and influencing skills. Ability to effectively lead a cross-functional team in a matrix environment. Proven problem solving and timely decision making skills. Excellent leadership, risk management, planning and project management skills. Strong verbal and written communication and presentation skills. Ability to effectively interact with all levels of professionals and support staff. Participate in continuous improvement initiatives in the department. Thorough knowledge of global regulatory requirements and ICH/GCP guidelines essential. Education Minimum requirement: Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development. Advanced degree is desirable. PMP certification desirable. *LI-MW1 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 PI112199859

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16144 Job Category: Clinical Development Location: Boston, MA Posting Date: July 22, 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 to work within the complement inhibition franchise. 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 Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring 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 Data review Essential Qualifications MD or equivalent History of industry or academic clinical or basic science research Excellent written / oral communication skills Ability to think strategically Willingness to take on new responsibilities Attention to detail Interest in career progression and ability to take on a more senior roles in 1-3 years Preferred Qualifications Minimum 3-5 years of industry experience Previous clinical trial experience as medical monitor in industry setting Safety medical monitoring and reporting experience Protocol development experience Understanding of regulatory requirements related to clinical trials Basic statistical knowledge Subspecialty certification Board Certification Business development experience Publication in peer reviewed journals *LI-MW1 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 PI112199797

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16139 Job Category: Clinical Operations Location: Boston, MA Posting Date: July 22, 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 will be responsible for the coordination and management of strategic R&D sourcing needs in support of Alexion's current and planned global clinical trials, including vendor identification and selection, Request for Proposal (RFP) and Bid Defenses, negotiating contracts, managing outsourcing budgets, vendor performance metrics, and vendor oversight and governance. This position will also be responsible for ensuring quality oversight of suppliers; maximize the value obtained from partnerships with external providers at study, program or supplier level. Job Duties & Responsibilities Manages the identification and selection process of R&D vendors such as CROs, Central Labs, Biometrics, IRT, QoL, etc. Generates Requests for Information (RFI) and RFPs and budget grids. Coordinates bid defenses and proposal review meetings and provides analysis to project teams. Contract lifecycle management: manages clinical contracts and change orders, including active negotiation of scope of work, payment terms and budgets. Assists with budget/forecasting needs, such as accruals, project budgets, etc. Ensures quality oversight of suppliers. Partners with suppliers and internal stakeholders to identify, manage, escalate and resolve issues related to supplier performance. Measures supplier performance activities; and communicating feedback to the supplier, encourage adaptation on best practices across supplier types and development of continuous process improvements/ maintenance. Facilitates and executes supplier governance meetings and operating reviews. Develops effective partnerships with suppliers and internal stakeholders. Identify/monitor current trends in outsourcing practices in the industry. Identifies, develops and implements outsourcing processes and procedures. Leads and contributes to complex functional or company initiatives Essential Qualifications Bachelor's degree required. Advanced degree is strongly preferred (Scientific, JD, MBA). Minimum of 10 years combined experience in pharmaceutical research, legal, strategy, clinical trial support or financial analysis required. Prefer Pharmaceutical, Licensing, CRO or Legal experience. Strong knowledge of drug development, project management, quality assurance, clinical and non-clinical research, legal and regulatory functions. Strong understanding of outsourcing processes, corporate purchasing standards, legal, QA and finance policies and procedures. Demonstrated leadership skills with a very broad business orientation. Proven project management skills. Demonstrated success in managing broad scope projects involving cross-functional teamwork. Demonstrated ability to think and plan strategically. Position requires strong analytical skills to understand scientific and financial data, recognize key issues and establish priorities. Must have demonstrated strong negotiation skills through past experience. Excellent communication skills both (written and verbal). Experience in preparing/presenting key information to stakeholders and management. Requires problem solving abilities at both strategic and operational levels. To identify and resolve issues related to a contract, or management of the supplier to the contract or management of performance issues. This involves both internal cross-functional problem solving as well as issue resolution between functional areas and external suppliers *LI-MW1 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 PI112199764

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16145 Job Category: Clinical Development Location: Boston, MA Posting Date: July 22, 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 to work within the complement inhibition franchise. 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 Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring 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 Data review Essential Qualifications MD or equivalent History of industry or academic clinical or basic science research Excellent written / oral communication skills Ability to think strategically Willingness to take on new responsibilities Attention to detail Interest in career progression and ability to take on a more senior roles in 1-3 years Preferred Qualifications Minimum 3-5 years of industry experience Previous clinical trial experience as medical monitor in industry setting Safety medical monitoring and reporting experience Protocol development experience Understanding of regulatory requirements related to clinical trials Basic statistical knowledge Subspecialty certification Board Certification Business development experience Publication in peer reviewed journals *LI-MW1 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 PI112199812

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16148 Job Category: Global Medical Affairs Location: Boston, MA Posting Date: July 22, 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 US Medical Affairs Specialist will primarily be responsible for a variety of administrative activities in support of the US Medical Affairs Vice President as well as serves as the key point of contact for coordination of departmental activities between internal departments and outside parties/vendors. This position will also perform project management and operational tasks in support of functional Strategic Programs. Job Duties & Responsibilities Administrative Assistant Handle day to day administrative responsibilities including scheduling of meetings (includes video meetings using Zoom and other technologies), managing inboxes and calendars using MS Outlook Preparation of complex, ever changing international and domestic travel arrangements; including: booking flights, accommodation, car service, arranging meetings and preparation of itineraries Ability to manage files and team collaboration sites including managing access lists, directories and basic assistance with the usage of collaboration locations. Liaise with senior level executives and their staff to coordinate activities and meetings around the globe Ability to handle extremely confidential and proprietary information with utmost discretion Act as gatekeeper, screening phone calls, responding or delegating to insure timely response Coordinate USMA VP meetings, conference calls and global video conferences including advanced preparation of materials and audio/visual facilities Process invoices and expenses ensuring all are paid on time while adhering to strict compliance guidelines, play a key role in budget tracking Willingness to learn and adapt to changing technology. Partners with information technology on continuous improvement initiatives. Eager to lead the adoption of new technologies and help ensure their successful utilization. Mailing, tracking and documenting confidential documents Responsible for filing, copying, scanning and faxing Other duties as assigned Project Management Leadership Team and Full USMA Team meeting events planning, including venue sourcing and contract negotiation, site selection recommendations, pre-event cross functional planning, meeting objective planning, onsite execution and post event close out activities. Key point of contact for hotel and vendors. Coordinated effort to help support SAP procurement tool, Purchase Orders, requisitions, invoice tracking, and payment of vendors Logistics and Planning support for medical Congresses including cross-functional alignment on Alexion congress strategy, planning timelines, partnering with logistics vendors and overall project management in support of US Medical Affairs. Consolidation of Monthly Management reports Recognizes opportunities and challenges and applies creative thinking to maximize performance Managing the medical affairs master calendar across multiple disease state engagement plans and with multiple internal and external stakeholders Essential Qualifications The ideal candidate will have a strong work ethic, be professional, organized and detail-oriented. This is a team-oriented position that plays an integral role in facilitating processes and procedures and ability to remain confidential is critical. They will also demonstrate the ability to work independently with minimal direction. Candidate must possess excellent interpersonal, written and verbal communication skills with a minimum of 5 years of experience using MS Office Suite (MS Word, Excel, PowerPoint and Outlook) Project Management Experience desired Prior Pharmaceutical experience desired Technically proficient with common tools used in executing job functions Ability to learn and adapt to evolving technologies allowing executives to be productive from any location Highly proactive and willing to take initiative Ability to maintain confidentiality Strong relationship building skills – with peers and Administrative teams Mature and must remain composed while multi-tasking under pressure Ability to prioritize, identify problems and seek solutions *LI-MW1 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 PI112199909

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16137 Job Category: Biostatistics, Clinical Data Management, & Programming Location: Boston, MA Posting Date: July 22, 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 *LI-MW1 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 PI112199974

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16133 Job Category: Biostatistics, Clinical Data Management, & Programming Location: Boston, MA Posting Date: July 22, 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, Biostatistics oversees all biostatistics activities for multiple clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes and standards to achieve quality and maximize efficiency. He/she works closely with Clinical Physicians, Clinical Operations, Safety, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. This individual is also responsible for production of biostatistics deliverables, managing a team of internal and external biostatistics and statistical programming resources. PRINCIPAL ACTIVITIES Lead and manage team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Manage assignments and priorities of team members. Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents. Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions. Leverage standardization to maximize global data integration and interpretability. Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up. Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies. Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program. Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines. REQUIREMENTS A PhD in Statistics/Biostatistics and at least 8 years of pharmaceutical experience are preferred. The successful candidate must also possess the following: comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics; BLA/NDA experience including eCTD submissions; working knowledge of major statistical software programs including SAS; knowledge of CDISC requirements for SDTM and ADaM; excellent verbal and written communication skills, and excellent inter-personal skills. The qualified applicant must also be flexible, well-organized, and have the ability to work well under pressure *LI-MW1 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 PI112200067

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16107 Job Category: Regulatory Affairs Location: Boston, MA Posting Date: July 22, 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 Publishing Manager will be coordinating the publishing activities within GRO and will perform routine and nonroutine submission tasks, including publishing, scheduling, submission compilation, QC, validation, dispatch and archiving of electronic and paper submissions (when needed) for Alexion's portfolio. The Publishing Manager will also work with Regulatory Sub-Teams and Submission Project Teams to provide guidance about electronic and paper submission requirements. The Publishing Manager will be responsible for publishing and preparation of high quality global submission dossiers, ensuring Alexion delivers compliant submissions to global health authorities within required timeframes. All publishing staff will assist with the evaluation, development, and implementation of systems and processes used to support regulatory activities, including planning and tracking regulatory activities, document requirements, document management, publishing, archiving (ie, Regulatory Information Management). The Publishing Manager will be involved in mentoring and training junior publishers and others who will perform publishing tasks within GRO. The Publishing Manager will also work with the Regulatory Business System Support Lead (and other stakeholders, including IT) in planning and implementation of upgrades for publishing and validation system at Alexion. The Publishing Manager will act as the primary point of contact with Submission Managers for major projects when significant planning effort and oversight is required. The Publishing Manager will also assist the Submission Operations Lead in activities related to setting standards, best practices, KPIs collection, developing new procedures and work instructions, and lessons learned dissemination and will assist in other activities as needed. It is also expected that Publishing Manager will be involved in dossier management and archiving activities within GRO. Job Duties & Responsibilities Manages overall publishing activities within GRO Distributes publishing tasks among publishers and makes assignments Trains publishers on routine and more complicated tasks Publishes both routine (eg, CSRs, IBs, PSURs) and also more complicated publishing projects (eg, datasets, CRFs, regional documents) for eCTD, NeeS and paper submissions. Compiles submissions and dispatches through Electronic submission gateways Ensures acceptable format of documents received in Submission Operations Ensures the final submitted documents are physically (paper) and electronically archived Develops, reviews, maintains and disseminates publishing Service Level Agreements (SLAs) for different submission categories for efficient planning and resource management. Monitors the development of new regulatory requirements or guidances, and provides advice to Global Regulatory Operations and product teams of the impact on the business. Contributes to development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authorities Participates in selection and implementation of electronic Regulatory Document Management systems Participates in compliant and timely archiving of regulatory submissions and correspondences for Alexion products Assists the Submission Operations Lead in assessing impact of standards and requirements with a regional impact to existing and new systems. Works with GRO leadership to oversee strategic implementation of outsourcing services, when needed Ensures SOP adherence, application of best practices, oversight of contractors and CROs, and customer/stakeholder interactions, and overall vendor management activities. Participates and shares lessons learnt sessions to encourage process improvement and efficiencies within and across submission project teams. Negotiates and agrees on realistic dates for document handoffs in collaboration with the project managers, authors and submission managers. As a global publishing expert, ensures the submission project team has sufficient awareness and knowledge on the application of e-submission (eCTD, NeeS, etc.) requirements and lifecycle management concepts and communicates regional differences (general formatting, template adherence, submission standards and procedures and version control) for their specific submission, within the context of global submission preparation. Assists with other Regulatory Operations activities Assists with training and development of all Regulatory Operations staff Essential Qualifications A minimum of 6 years of experience in the pharmaceutical/biotech industry and at least 3 years of direct experience with regulatory submission requirements (publishing) required. Strong verbal and written communication and presentation skills. A superb training skill is a plus. Strong interpersonal skills and ability to work effectively and build relationships with cross- functional teams. Self-motivated and results-oriented with high energy drive to mentor junior members of the group Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for global submission types (e.g. IND, BLA, MAA, NDS, CTA, PSUR etc.). Excellent experience in publishing and compilation of eCTD submissions for US and EU filings is required and experience publishing electronic submissions in other regions is desirable. Expert knowledge and working experience with eCTD Validation tools (Lorenz eValidator, Extedo Global Validator, Global Submit, etc.) and other publishing and QC tools (ISIToolbox, PDF Tools, etc.) is required. Expert knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools. Solid experience and knowledge of SharePoint technology is desired. Advanced knowledge of Microsoft Word, Excel and Visio, and document formatting requirements. Experience with implementation and utilization of electronic submission gateways (ESGs) In-depth knowledge of StartingPoint templates. Demonstrated project management, organizational and planning skills. Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines. Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities. Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project time-lines. Prior project or submission management and archiving experience is highly desirable and preferred Solid knowledge of CDISC compliant datasets and CRFs and other regional requirements is a must. Prior experience with preparation of SPL submissions and working with SPL vendors is highly desirable. Preferred Qualifications A minimum of a Bachelor's degree in a scientific or technical discipline is required; equivalent experience may be accepted. Advanced degree in a scientific discipline preferred. A minimum of 6 years pharmaceutical or other related industry experience with 3+ years of direct regulatory operations and publishing experience *LI-MW1 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 PI112200083

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16118 Job Category: Clinical Operations Location: Boston, MA Posting Date: July 22, 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. *LI-MW1 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 PI112200098

Alexion Pharmaceuticals, Inc. Alexion is an Equal Opportunity/Affirmative Action Employer. Req ID: 16134 Job Category: Biostatistics, Clinical Data Management, & Programming Location: Boston, MA Posting Date: July 22, 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, Biostatistics oversees all biostatistics activities for multiple clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes and standards to achieve quality and maximize efficiency. He/she works closely with Clinical Physicians, Clinical Operations, Safety, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. This individual is also responsible for production of biostatistics deliverables, managing a team of internal and external biostatistics and statistical programming resources. PRINCIPAL ACTIVITIES Lead and manage team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Manage assignments and priorities of team members. Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents. Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions. Leverage standardization to maximize global data integration and interpretability. Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up. Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies. Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program. Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines. REQUIREMENTS A PhD in Statistics/Biostatistics and at least 8 years of pharmaceutical experience are preferred. The successful candidate must also possess the following: comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics; BLA/NDA experience including eCTD submissions; working knowledge of major statistical software programs including SAS; knowledge of CDISC requirements for SDTM and ADaM; excellent verbal and written communication skills, and excellent inter-personal skills. The qualified applicant must also be flexible, well-organized, and have the ability to work well under pressure *LI-MW1 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 PI112200116

Job Description   We are seeking a Registered Nurse to join our team!  About the positions: OR, ER, PACU, LTC, Med Surg, PCU, Tele, L&D, ICU, Psych, & More! 13 weeks contracts with option to extend or go permanent All shifts available Full time hours ASAP start dates Housing and meal stipends included in weekly paychecks Responsibilities: Administer nursing care to ill, injured, or disabled patients Diagnose and establish patient treatment plans Monitor and report changes in patient symptoms or behavior Communicate with collaborating physicians or specialists regarding patient care Educate patients about health maintenance and disease prevention Facilitate referrals to other healthcare professionals and medical facilities Maintain accurate patient medical records Provide advice and emotional support to patients and their family members Qualifications: 1+ year experience as a licensed RN or LPN 1+ year experience in the specialty Active state RN license Active BLS, ACLS, PALS, TNCC, etc. as required by specialty Company Description Alegiant Healthcare has become the go-to medical staffing company for nurses, advanced practice, and allied health across the United States. Alegiant is committed to being the premier provider of high-quality services and solutions in the healthcare industry. We are dedicated to having a very motivated and skilled team of professionals who perform the highest level of quality work each and every day. By setting these top standards for our organization, and by drawing from all available knowledge and resources, our ability to provide exceptional customer service with honesty and integrity is unmatched.

Job Description CFI is Looking for Recent Grads! Excellent Pay and Benefits - Reliable Home Time Solo and Team Opportunities Available   CFI offers several routes to becoming a professional Regional or Over-the-Road (OTR) driver. If you already hold a CDL with little experience, and need to go out with a Finisher (Trainer), we’ll help you start the process. Ask About Tuition Reimbursement! When working toward your driving career at CFI, we’ll make your monthly tuition payments for the first 12 months of employment and then pay off the remainder of your tuition, up to $4,500 total.   When you drive for CFI, you can count on: Company Drivers earn up to $.47 per mile Practical mile pay Both Regional and OTR available Reliable home time Consistent freight Tuition Reimbursement Stop-off pay, Canadian border pay, local pay, layover pay, & non customary work pay Northeast bonus, holiday bonus, HAZMAT bonus, & performance-based bonuses Up to .04 per mile safety bonus Free rider program Pet program Electronic logs (e-logs) used by full fleet Career advancement opportunities Modern, state-of-the-art equipment and safety technologies A team that feels like family   Qualifications: 21 years of age or older Have the right to work and live in the United States Be willing to travel throughout all 48 contiguous states and Canada for two to three weeks at a time No BACs, DUIs, DWIs or license suspensions for moving violations in the past five years HAZMAT endorsement or willingness to obtain a HAZMAT endorsement within 120 days of hire Ability to meet work attendance and availability requirements and meet all applicable legal and DOT regulations to drive a commercial truck in the United States and Canada Ability to pass all applicable CFI certification class testing and requirements   Interested in Driving with CFI? Apply Now! It is the policy of CFI to provide equal employment and individual opportunity to all job applicants and employees without regard to race, color, religion, sex, age, national origin, disability, veteran status or any other status as protected by federal, state and local governments. Company Description CFI offers several routes to becoming a professional Regional or Over-the-Road (OTR) driver. If you already hold a CDL with little experience, and need to go out with a Finisher (Trainer), we’ll help you start the process.

Job Description Firm seeking to hire an Finance Attorney with a minimum of 6 years of experience working with borrowers, banks, funds and other lenders on deals involving secured and unsecured bank, mezzanine and other senior and subordinated lending. Ideal candidate has strong experience with subordination and intercreditor arrangements, negotiating financial covenants and intercreditor matters inherent in mezzanine financing, perfecting collateral, advising private equity clients in LBOs and refinancings, and representing financial institutions in secured loan transactions involving individuals and/or investment vehicles. FIrm is considering candidates in NY, CT, and Boston, MA.  Admission to the bar in which the attorney is resident is required.   Company Description Elite Consulting Partners provides advisor transition, business, and broker-dealer M&A consulting to the financial services industry. Through unparalleled service and strategic, unbiased advice we have set ourselves apart with advisors and corporate clients alike. Our areas of specialization include transitioning advisors to a new retail or independent broker-dealer or RIA and investment advisory firms, custodial platform changes, monetizing the equity within a practice or business through succession planning, negotiated mergers, increasing head-count, and advisor recruiting deals and packages of any scope. We take pride in serving as the bridge connecting advisors and businesses to unbiased actionable opportunities - all while insuring every clients' objectives and goals are realized during their due-diligence and transition process. Our intelligence covers a variety of landscapes including the wire-house domain, regional firms, independent broker dealers, RIA’s and hybrids. We also have the ability to partner with firms who have additional expertise within independent advisories, M&A’s, practice management, succession planning, and business valuation disciplines. These partnerships allow us to deliver a turn-key consulting experience.