- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… 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 Oversight: ... 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
- 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)
- …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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Associate Director , Data Management is responsible for oversight of data ... management for clinical development studies within all MTPA therapeutic areas. The Associate Director works with departmental and cross-functional teams to… more
- The Institute for Family Health (New York, NY)
- ASSOCIATE DIRECTOR WIC PROGRAM Job Details Level Management Job Location WIC Sites 2 - New York, NY Position Type Full Time Education Level 2 Year Degree Salary ... and Children (WIC) under the supervision of the WIC Director , Associate Director or the...including typing, Microsoft word, Excel, Power Point + Good writing and organizational skills + Strong interpersonal skills. Qualifications… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… 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
- 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
- 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
- TIAA (New York, NY)
- ** Associate General Counsel** The Director , Associate General Counsel will join a team responsible for providing legal advice and strategic guidance for ... TIAA India, and other key partners on new laws and regulatory developments, including those applicable to marketing, communications, digital experiences, educational… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …our team. The ideal candidate will have a strong background in scientific writing , medical terminology, and a deep understanding of HIV and virology research. The ... Viral Hepatitis/Liver Disease research, including new therapies, treatments, and regulatory changes, and communicate relevant information to internal teams.… 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
- 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
