- 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. (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
- 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 ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… 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
- 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
- Taiho Oncology (Princeton, NJ)
- …and execution, analysis and reporting of data, and authoring/review of scientific and regulatory documents. The Associate Director of Biostatistics will have ... Associate Director , Biostatistics Princeton, NJ, USA...clinical data + Create/author statistical sections of scientific and/or regulatory documents + Manage external biostatisticians to ensure quality… more
- Sanofi Group (Bridgewater, NJ)
- **Job title** : Associate Director , Global Oncology Corporate Communications **Location:** Cambridge, MA 50% remote working; limited travel expected. **About the ... the world. Sanofi is looking for a proactive, high-energy Associate Director to join the Global Specialty...global communications programming in support of clinical data and regulatory milestones as well as pipeline; 2) supporting development… 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
- Bristol Myers Squibb (Princeton, NJ)
- …Responsibilities: + Develops expertise beyond biostatistics by researching medical literature, regulatory and HTA documents to develop an understanding of the ... clinical, regulatory /HTA and commercial climate. + Contributes to preparation of...data manipulation, graphing & simulation. + Great interpersonal, communication, writing and organizational skills. + Expertise in statistical/clinical trials… 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
