- 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)
- …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
- 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
- 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
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director , Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... stakeholders. **Essential** **Functions** **of** **the** **job:** + Develop European and/or UK regulatory strategy for the designated program , and contribute to… 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
- ITG Brands (Greensboro, NC)
- State Government Affairs Director **Location** North Carolina **City** Greensboro **Role Type** Permanent **WHO WE ARE** ITG Brands is the third-largest tobacco ... - JOB SUMMARY Responsible for leading Company's state government affairs strategy across a designated region of the United...regulators, and other stakeholders who shape the legislative and regulatory environment. The Director will serve as… more
- Olympus Corporation of the Americas (Washington, DC)
- …committees. **Preferred:** + Demonstrated success building or significantly expanding a government affairs program . + Deep understanding of US healthcare policy, ... preferred. + Minimum 15+ years of experience in government affairs , public policy, or regulatory strategy, with...coverage effective on start date + 24/7 Employee Assistance Program + Free live and on-demand Wellbeing Programs +… more
- Coty (Morris Plains, NJ)
- …part of the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR...leave; Tuition reimbursement; Hybrid work arrangements. *Benefits and compensation program descriptions are general in nature and may be… 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
- BeOne Medicines (San Mateo, CA)
- …using clinical trial, real-world and post-marketing surveillance data. + Partner with regulatory affairs teams to establish and monitor competitive landscapes, ... functions to define KPIs, OKRs, metrics as pertained to pharmacovigilant and regulatory affairs , develop and implement role-based dashboards or analytical tools… 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
- 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
- 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
- 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
- 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
- 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
- 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
