- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing ... global regulatory strategies and plans to enable...PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be ... Affairs Impact and Omnichannel strategy. This is a global role which will work across regions, functions and...of related experience working in data analytics in commercial, regulatory , market access or medical affairs function… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... science or healthcare preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the… more
- Insmed Incorporated (San Diego, CA)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on ... teamsWith oversight from the VP of Regulatory Affairs , lead the development and implementation of global... Affairs , lead the development and implementation of global regulatory strategy plans to facilitate efficient… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible for supporting the ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...vision. This position will report directly to the Executive Director of Medical Affairs . Together with the… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing the ... understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for continuous quality improvement.Deputize for the Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director...or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in… more
- Insmed Incorporated (NJ)
- …regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory ... agency interactions and product development meetings.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development… more
- Insmed Incorporated (NJ)
- …E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs , drug development, FDA and regulatory guidelines (ie, ... functional impact metrics.Cross-functional Alignment - Partner across all of Medical Affairs , particularly with Global Medical Strategy, Regions, Field Medical,… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead...of an exciting, passionate, high profile, high impact Medical Affairs team, and work in a highly dynamic and… more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionOur company is a global health care leader with a diversified portfolio...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and governance meetings Lead cross-functional improvement projects with stakeholders from Quality, Regulatory Affairs , IT, and Global Units Manage change ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...automation, and continuous improvement. Relationships Reports to the Executive Director , PS & GxP Business Operations. Accountable for establishing… more
- Merck & Co. (Upper Gwynedd, PA)
- …(V&I) Outcomes Research, position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research.Under ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers and Global Value Dossiers for use by local subsidiaries in their HTA submissions.The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our TPIP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work together to change lives for the better. The Position The Associate Director , Media Relations & Issues Management is accountable for establishing and leading ... potential to dramatically influence stakeholder perceptions. Relationships Reports to the Director , Media & Stakeholder Relations, and interacts with senior leaders… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date ... Legend Biotech is a global biotechnology company dedicated to treating, and one...the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
- Insmed Incorporated (NJ)
- …Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial Operations ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our brensocatib… more
