- 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
- 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
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an ... exciting, passionate, high profile, high impact Medical Affairs team, and work in a highly dynamic and...and work in a highly dynamic and collaborative setting.The Director , HEOL Team Lead is part of the US… 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...reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... and for the future of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our TPIP program in Pulmonary Arterial Hypertension… more
- Insmed Incorporated (NJ)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial ... and for the future of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our brensocatib program in HS (hidradenitis… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based ... research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate utilization based on… more
- Merck & Co. (North Wales, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (North Wales, PA)
- …and executing integrated development plans that align clinical, medical affairs , commercial, manufacturing, regulatory , analytical, and epidemiological ... and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific oversight… more
- Unknown (San Antonio, TX)
- Senior Director , Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About ... the Role The Senior Director , Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the… more
- Lundbeck (Deerfield, IL)
- …sign-off authorization. + Ensures all activities are following ICH, and other international regulatory guidelines and relevant GCPs and SOPs. + Participates ... Associate Director Medical Affairs - Neurology Requisition...leaders. + Professional society membership(s) relevant to migraine/headache. + Regulatory knowledge and exposure, including experience with international… more
- BeOne Medicines (Emeryville, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity** As the Senior Director , Medical Affairs , you will lead the development and execution of Medical Affairs strategies and tactics to support ... leaders in relevant fields + Review and approve medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs , and Commercial +… more
- Programmable Medicine Operatin (Redwood City, CA)
- …meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and ... our external contract manufacturing network while ensuring compliance with cGMP, regulatory requirements. This is an individual contributor, hands-on position. As… more
- CSL Behring (King Of Prussia, PA)
- …social media, HCP/patient brochures, press releases) for consistency with local and international regulatory requirements (eg, EMA, PMDA). - ** Regulatory ... a meaningful difference worldwide. Could you be our next Director , Global Advertising and Promotion? The job is in...& Experience Requirements** Bachelor's degree required. -8+ years of Regulatory Affairs experience, with at least 6+… more
- DHL Express, Inc. (Plantation, FL)
- …the VP of Customs and Regulatory Affairs and the leaders of: Regulatory Affairs , International Trade Affairs Legal, Customs Compliance, Security ... lives. **Grow YOUR career with DHL today ** The Director of Customs Customer Support for DHL Express Americas...+ Trade Knowledge Support: Review, interpret (in conjunction with regulatory affairs and knowledge support, whether regional… more
- Caris Life Sciences (Irving, TX)
- …Oncology, with deep experience in malignant hematology, to join our dynamic Medical Affairs team as **Senior Medical Director ** . This individual will serve ... hematologic malignancies. + At least 3 years of experience in a senior Medical Affairs , Medical Director , or equivalent leadership role in the biotech or… more
- Micron Technology, Inc. (Boise, ID)
- …including hazard identification, risk assessment, and incident prevention. + Compliance & Regulatory Affairs : Supervise and ensure adherence to safety and health ... and seasoned leader to take on the position of Director of Global Safety and Health. This role will...director will lead cross-functional teams, ensure adherence to international regulations, and cultivate a proactive safety culture throughout… more
- Endo International (St. Louis, MO)
- …insights + Ability to operate within cross-functional teams (eg, sales, commercial, regulatory affairs , supply chain, etc.). + Ability to manage tight ... skills are desirable. **ORGANIZATIONAL RELATIONSHIPS/SCOPE** **:** + Reports to the Director Product Management + Interfaces with various functional areas both… more
