- Eisai, Inc (Jersey City, NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Medical Writing will be the designated Lead Medical Writer ... as the briefing books, Global Investigator Brochures, and annual regulatory reports Leads the medical writing...Salary Transparency Language:The base salary range for the Associate Director , Medical Writing is from… more
- 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
- Merck & Co. (Rahway, NJ)
- …the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents. Partners with Study ... data/ medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members through proactive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on digital channels Manages and builds relationships with internal teams; Legal, Medical and Regulatory Translates best practices for digital and corporate ... change lives for the better. The Position The Associate Director , Digital Content Strategy & Production reports to the...ability to jump from creative to analytics Maintains excellent writing and language skills Enjoys a working knowledge of… 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
- Genmab (Plainsboro, NJ)
- …, Programming, and work closely with Data Management, Clinical Programming, Statistics, Medical Writing , and other functions as necessary.Position level for this ... to a specific candidate is at the discretion of the Director , Programming.Key responsibilities include:Supports and/or leads programming efforts within a clinical… more
- Merck & Co. (North Wales, PA)
- …medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in the development of ... This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/… more
- Eisai, Inc (Baltimore, MD)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... Metrology program, ensuring goals and tasks are met within. Interact with regulatory agencies as needed.Monitors and manages calibration program and technicians to… 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: Nov 29, 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: Nov 17, 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
- Vera Therapeutics (Brisbane, CA)
- Job Title: Associate Director , Medical Writing Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company ... from immunological diseases. Position Summary: Reporting to the Senior Director , Medical Writing , the Associate...all of Vera's drug development programs, producing high quality regulatory and clinical documents that meet regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance ... writer to join our dynamic team at the Associate Director level. You will author a wide range of...products or projects. You will represent Medical Writing on relevant product, project, and/or 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
- Lilly (Indianapolis, IN)
- …**Additional Information:** + This role will report to the Associate Vice President, ExploR&D, Regulatory Affairs, Medical Writing , and Quality. + Core work ... to evolve how Lilly and LRL operates. The **Senior Director /Executive Director ** is responsible for managing all Regulatory activities (strategy and… more
- Sumitomo Pharma (Columbus, OH)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs** . The Associate Director is part ... to electronic regulatory submissions and working with regulatory templates + Solid understanding of medical ...and the ability to contribute to the development and writing of a regulatory strategy document in… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... 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
