- Insmed Incorporated (NJ)
- …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 to formulate regulatory strategies for post-approval… more
- Insmed Incorporated (NJ)
- … requirements and submission formats (eCTD)Proven experience managing complex regulatory deliverables across product lifecycle stagesStrong submission writing ... 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 … more
- Insmed Incorporated (San Diego, CA)
- …EDC systems (ie, RAVE) and data analysis tools (ie, J-Review) requiredStrong medical writing and presentation skillsBasic understanding of biostatistics and data ... will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …If so, apply now We offer excellent comprehensive benefits including 100% City paid medical , dental and vision premiums for the 2025-2026 Plan Year. We also offer ... Brief Description of Duties: Under the supervision of the City Administrator, the Director of Community Development is an exempt position under FLSA. Ensuring that… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for...health economics and outcomes research strategies, and timelines with medical affairs, marketing, managed markets and global value and… more
- Insmed Incorporated (NJ)
- …our business forward. The ideal candidate is a savvy storyteller with exceptional writing and editorial skills, a sharp creative instinct, and a strong grasp of ... or agency experience in the biopharmaceutical industry strongly preferredExceptional writing and communication skills-you make complex ideas clear and… more
- Eisai, Inc (Philadelphia, PA)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... marketplace within which they operate. Work closely with Medicaid Director and other cross-functional teams to review and analyze...inform Eisai field sales of access status for both medical and pharmacy benefit products. Work with various key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Responsibilities: Daiichi Sankyo Inc's Oncology Publications team within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems and Operations… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... of GPOs. This is a field-based position that reports to the Director , GPO. Responsibilities: 1. Ownership of Contract Management within assigned GPO member… more
- J&J Family of Companies (Spring House, PA)
- …searching for the best talent for a **Senior Manager/Associate Director ** , ** Regulatory Medical Writing ** within our Integrated Data Analytics & ... Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area. **The position can be located at any of our following… more
- J&J Family of Companies (Titusville, NJ)
- …applications will be considered as a single submission. **Purpose:** The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with ... Learn more at https://www.jnj.com/innovative-medicine **We are searching for the best talent for Director , Medical Writing , Oncology.** Please note that this… more
- Teva Pharmaceuticals (West Chester, PA)
- …new people to make a difference with. **The opportunity** The Director , in Global Regulatory Medical Writing , may write and edit clinical regulatory ... Director , Therapy Area Head, Medical Writing - REMOTE (EST/CST) Date:...documents include the proper context and context (from a regulatory medical writing perspective) and… more
- J&J Family of Companies (Raritan, NJ)
- …more at https://www.jnj.com/medtech We are searching for the best talent for an **Associate Director , Medical Writing & Literature Services** . _Remote work ... approved by the Company_ . **Purpose** : The Associate Director , Medical Writing and Literature...Surgery in support of Clinical, Medical , and Regulatory needs. These medical writing … more
- University of Pennsylvania (Philadelphia, PA)
- …education or experience with IND/IDE/Expanded Access Applications, drug development process, medical writing , and clinical trial operations required. + Qualified ... and resources, and much more. Posted Job Title Associate Director , Regulatory Job Profile Title Associate ...problem solving and critical thinking abilities; effective communication and writing skills; be flexible and able to multi-task. Prior… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …work remotely from a New England state (ME, VT, NH, MA, CT, RI).** The Regulatory Compliance Director is a key part of the Compliance team, collaborating across ... federal and state healthcare laws, payer requirements and internal policies. The Regulatory Compliance Director is responsible for developing, implementing, and… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Regulatory Affairs Diagnostics. This position is a hybrid ... your application. We invite candidates from any location to apply. The Associate Director , Global Regulatory Affairs Diagnostics will provide an opportunity to… more
- Sumitomo Pharma (Frankfort, KY)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs. The Associate Director is part of ... to electronic regulatory submissions and working with regulatory templates + Advanced understanding of medical ...and the ability to contribute to the development and writing of a regulatory strategy document +… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is ... urgency and perseverance to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific...and the ability to contribute to the development and writing of a regulatory strategy document +… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …grow and become your best self. Become a **maker of possible** with us. The Director , Regulatory Affairs will be a member of the Peripheral Intravenous Catheter ... preferred + 10+ years of progressively more responsible experience as a multi-functional Regulatory Affairs professional in the medical device industry + 10+… more
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