- 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 ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of … 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 ... Affairs strategic vision. This position will report directly to the Executive Director of Medical Affairs . Together with the Executive Director of… 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 ... CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders...by Technical Operations or from CMOs to support development program and life cycle management, and ensure they meet… more
- Novo Nordisk Inc. (WA)
- …reporting requirements for NNI personnel. Relationships This position reports to the Executive Director , Government Affairs and serves as the people leader over ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs ... , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory ...and working toward building a quality mindset with Medical Affairs .Support the Sr. Director 's Medical Affairs… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in ... candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well… more
- Genmab (NJ)
- …reports, evaluations, etc.)Attend medical/scientific meetings to represent US Field Medical Affairs /CORE and synthesize medical insight to enhance program ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree in a related field is preferred 10+ years of experience in pharmaceutical, regulatory affairs , or compliance roles, with a strong background in patient ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …governance meetings Lead cross-functional improvement projects with stakeholders from Quality, Regulatory Affairs , IT, and Global Units Manage change initiatives ... 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
- 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
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global ... Medical and Scientific Affairs as well as Outcomes Research.Under the guidance of...achieve / sustain reimbursement and market access for the program and indications under their responsibility.Critically assesses drivers and… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… 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
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our TPIP..., Head of US HCP Marketing for our TPIP program in Pulmonary Arterial Hypertension (PAH) will be responsible… 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)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial ... of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our brensocatib..., Head of US HCP Marketing for our brensocatib program in HS (hidradenitis suppurativa) will be responsible for… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Insmed Incorporated (NJ)
- …QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC ... or practices from external labs.Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs , Supply Chain, and other departments to ensure… more
- Insmed Incorporated (San Diego, CA)
- …closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.What You'll Do: EDC System ... and for the future of science, we're in. Are you?About the Role:The Associate Director , EDC Programming will lead and oversee EDC programming, and database build for… more
