- 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
- 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
- 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
- Bristol Myers Squibb (Summit, NJ)
- …cell therapies enabling global regulatory approval and launches. The ** Associate Director , Program Management** plays an important role in organizing, ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** Associate Director , Program Management, Global Operations (Inline Asset… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Associate Director , Communication & Omni-Channel Marketing is responsible for developing and leading the creation and execution ... Become a **maker of possible** with us. **Summary of Position** + The Associate Director , Communication & Omni-Channel Marketing is responsible for developing… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director , Biostatistics is responsible for providing statistical support to ... deliverables for contracted statistical services. + Provides statistical components of regulatory submissions. + Assists the Department Head in the preparation of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director , Statistical Programming is responsible for building and maintaining ... programming requirements in the preparation of documents for submission to regulatory authorities, including but not limited to, Investigational Drug Applications… more
- Merck (Rahway, NJ)
- **Job Description** The 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …the production planning process. + Ensure compliance with industry standards and regulatory requirements. + Lead and mentor the production planning team, fostering a ... demand planning strategies, drive alignment effectively. **General** + Fluent English ( writing , reading, speaking, and listening) + Local languages **Experience and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …designs 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 (Rahway, NJ)
- …, Operations, Non-clinical, Clinical, and other functional areas + Experience 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
- Merck (Rahway, NJ)
- …, Operations, Non-clinical, Clinical, and other functional areas + Experience 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
- PSEG (Newark, NJ)
- …as the attention, camaraderie, and care for one another you might typically associate with a small business. Our focus on combatting climate change through clean ... internal controls and maintenance of tax accounting related databases. In addition, the Director - Tax Accounting and Reporting collaborates with the Director of… more
- Merck (Rahway, NJ)
- **Job Description** The Executive Director , Global Pharma Communications is responsible for leading, developing and executing US and global communications strategies ... infectious diseases, neuroscience, ophthalmology, and immunology. Reporting to the Associate Vice President, Human Health and Manufacturing Communications, the… more
- Merck (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
- Teva Pharmaceuticals (Parsippany, NJ)
- …to clinical studies or programs with the guidance of senior level statisticians (ie, Associate Director or higher) which includes, but is not limited to, ... but not limited to, strategic planning, study designs, data analyses, and regulatory interactions. You'll be expected to have extensive knowledge about statistical… more
- Merck (Rahway, NJ)
- …reputation while ensuring effective internal and external stakeholder engagement.** **The Executive Director will report to the Associate Vice President, Human ... **Job Description** **The Executive Director , our Company's Manufacturing Division Communications, is responsible for leading communications for the company's… more