- 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
- 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 (Princeton, 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
- Merck (North Wales, PA)
- **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
- 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 (West Point, PA)
- …the use of risk assessment and process capability (Ppk) tools. + Experience with regulatory submissions including writing / review of regulatory filings ... Our company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development. Vaccine Drug Product Development (VDPD) team is… 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