- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... incumbent will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications skills,… more
- Merck & Co. (Durham, NC)
- …the globe.Reporting to the Director of Quality Systems and Compliance, the Associate Director - Quality Systems position will provide leadership, focus and ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor ... Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Global Pharma Communications is responsible for leading, developing and executing US and global communications strategies and ... infectious diseases, neuroscience, ophthalmology, and immunology. Reporting to the Associate Vice President, Human Health and Manufacturing Communications, the… more
- Merck & Co. (Rahway, NJ)
- …modeling, Quality by Design (QbD) and Lean Six Sigma principles. Experience supporting/ writing regulatory filings (IND, MAA, BLA) and inspections with multiple ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Merck & Co. (Rahway, NJ)
- …reputation while ensuring effective internal and external stakeholder engagement. The Executive Director will report to the Associate Vice President, Human ... Job DescriptionThe Executive Director , our Company's Manufacturing Division Communications, is responsible for leading communications for the company's worldwide… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role responsible for ... strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working… more
- J&J Family of Companies (Spring House, PA)
- We are recruiting for an Associate Director to join the Regulatory Medical Writing team to support the Oncology therapeutic area. The position may be ... role will report directly to the Hematologic Malignancies Disease Area Head, Regulatory Medical Writing , Oncology. + Is the primary point of contact for MW… more
- Novo Nordisk (Lexington, MA)
- …input into development plans, study designs, and regulatory submissions. Relationships The Associate Director , Medical Writing (ADMW) reports to a ... make a difference? The Position The Associate Director is an expert in medical writing ... regulatory requirements of a clinical program. The Associate Director will provide high level strategic… 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 ... Summary: Reporting to the Senior Director , Medical Writing , the Associate Director , Medical...all of Vera's drug development programs, producing high quality regulatory and clinical documents that meet regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …exciting and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory ... content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's… more
- Guidehouse (Mclean, VA)
- …to 25% **Clearance Required** **:** None **What You Will Do** **:** ** Associate Director - Regulatory Rate Design.** Responsibility for delivering ... to bring comprehensive enhancements to our clients. In this ** Associate Director - Regulatory Rate Design** role,...a close-knit team. + Business development experience to include writing and responding to proposals. + Excellent verbal and… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...region. + Ability to communicate both orally and in writing in Chinese, Japanese and/or other Asian language. +… more
- IQVIA (Parsippany, NJ)
- …or combination of education, training and experience * Extensive experience in regulatory and/or technical writing * Advanced negotiating and influencing skills ... Job Overview Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is… more
- University of Washington (Seattle, WA)
- …the WaNPRC, maintain regulatory compliance, and support cutting edge research.The Associate Director of Animal & Scientific Resources has broad oversight and ... Primate Research Center (WaNPRC) has an outstanding opportunity for a **full-time Associate Director of Animal and Scientific Resources.** The Washington… more
- IQVIA (Durham, NC)
- The Associate Director , Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally. ... global regulatory document standards. Mentors less experienced writers. Reports to a Director of Medical Writing or above. Essential Functions of the Job… more
- University of Colorado (Aurora, CO)
- **Ambulatory Associate Medical Director ** **Description** **University of Colorado Anschutz Medical Campus** **Department: Psychiatry** **Job Title:** ... **Ambulatory Associate Medical Director ** **Position #00829062 - Requisition...and Abilities:** + Ability to communicate effectively, both in writing and orally. + Ability to establish and maintain… more
