- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strong technical knowledge based upon academic training and job experience.Strong oral and writing skill. Able to write regulatory documents in highly complex ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … documents (eg, response to HAs, briefing book, etc.) in conjunction with Medical Writing - Leads scientific components of IM (Investigators Meeting) and SIV ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of sourcing strategies for a specific set of R&D categories (CRO, Medical Writing , BDM, etc..). Builds strategic plans for specific categories ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… 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 ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… 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 ... Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations. In… 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 ... rare diseases and immune disorders. We are currently seeking a Global Oncology Medical Affairs (GOMA) Publications Intern for summer 2025. This full time position… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical Writing & Data Transparency Date: Oct 31, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: ... difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing & Data Transparency provides leadership, direction, and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Oct 19, 2024 Location: Parsippany, United States, New Jersey, 07005 ... better, healthier lives. **The opportunity** As a ** Director , in Global Regulatory Medical Writing (GRMW)** , you will primarily work in a therapeutic… more
- Takeda Pharmaceuticals (Columbus, OH)
- … response documents and key components of regulatory submissions. + The Associate Director , Medical Writing is seen as an expert in medical ... therapies to patients worldwide. Join Takeda as a Associate Director Medical Writing where you...documents. Collaborate with all Takeda regions to ensure a medical writing regulatory document strategy… more
- Takeda Pharmaceuticals (Columbus, OH)
- …the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology ... contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory Writing...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Senior Director , Medical Writing Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused ... patients suffering from immunological diseases. Position Summary: The Senior Director , Medical Writing will report...all of Vera's drug development programs, producing high quality regulatory and clinical documents that meet regulatory … more
- AbbVie (North Chicago, IL)
- …for writing team within assigned therapeutic area(s). Responsibilities Serves as Medical Writing Lead on more complex writing assignments implementing ... about the product/disease state and is an expert on medical writing . Continually trains/be compliant with all...required or in a related area such as quality, regulatory , publications, clinical research, or product support/R&D 4 years… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our ... Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is...area or MBA + Minimum 5+ years' experience in regulatory affairs. + Experience working with Medical … more
- Guidehouse (Mclean, VA)
- …to 25% **Clearance Required** **:** None **What You Will Do** **:** ** Regulatory Rate Design Associate Director .** Responsibility for delivering Regulatory ... to bring comprehensive enhancements to our clients. In this ** Regulatory Rate Design Associate Director ** role, you...a close-knit team. + Business development experience to include writing and responding to proposals. + Excellent verbal and… more
- BeiGene (Emeryville, CA)
- …Ten+ years of relevant industry experience in a pharmaceutical, biotech or vendor medical writing position is required with a Bachelor's Degree. Previous ... in the MW talent development plan, such as the understanding of medical /scientific background and applicable guidelines (eg, regulatory , industry); + Foster… more
- Shell (San Diego, CA)
- …and supporting group efforts on others + Must have fundamental understanding of regulatory processes and strong writing skills. + Experience in modeling related ... Solutions related businesses through external advocacy for competitive markets, communicating regulatory changes and impacts of regulatory changes to commercial… more
- Pfizer (Boston, MA)
- …industry standards, new technology, and new processes that impact Medical Writing . + Proficiency with global regulatory guidance (especially ICH, FDA, and ... anticipated delays, information gaps, or potential shortcomings in quality. + Communicates Medical Writing 's position on resource and timeline needs for assigned… more
- Novo Nordisk (Lexington, MA)
- … Medical /Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing , Program Management, CMC and Regulatory Affairs teams. Will ... ready to make a difference? The Position The International Medical Director serves as a subject matter...Work with, Clinical Operations, Non-Clinical Research, Medical Writing , Program Management, CMC and Regulatory Affairs… more
- Stryker (Fremont, CA)
- …Clinical evaluation and/or summary reports. + All processes that lead to or rely on Medical Writing . This can include processes that relate to the generation of ... information and as well general overall marketing communications. + Manages the Medical Writing and Advance Evidence groups focusing on research supporting… more
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