- 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
- 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)
- … 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)
- Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing and executing US and global communications strategies and ... while improving and protecting patient access to care. Reporting to the Associate Vice President, Human Health and Manufacturing Communications, the Executive … 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. (Durham, NC)
- …metric generation.-By providing administrative support, the successful candidate will assist the Director and Associate Director with building and/or ... strategic direction facilitated by our global business model and regulatory compliance.--General Profile:Investigation of Product Quality Complaints and Adverse… 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
