- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job 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)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... activities and represents global function on study and project teamsProduces independent writing for publications & regulatory documentsServes as a specialist in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strong technical knowledge based upon academic training and job experience.Strong oral and writing skill. Able to write regulatory documents in highly complex ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of sourcing strategies for a specific set of R&D categories (CRO, Medical Writing , BDM, etc..). Builds strategic plans for specific categories under the direction of ... Demonstrates strong knowledge of the industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing… 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
- 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)
- …of Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and ... Operations. In collaboration with the Associate Director Global Strategy and Operations and...team lists and track projectsProvide Strategy Operations support for regulatory inspection related activities as required such as ensuring… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Job 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
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …depression in adults as monotherapy and as adjunctive therapy. The Associate Director / Director of Medical Writing provides support for the planning, ... preparation, and submission of clinical documents, Regulatory documents, and responses to health authority information requests....to health authority information requests. The Associate Director / Director of Medical Writing must… more
- Bristol Myers Squibb (Madison, NJ)
- …external resources; ensure appropriate quality controls in place for compliant submissions + Writing regulatory documents (eg new INDs, briefing book content, BT ... careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Policy Advocacy** The Associate Director , Policy Advocacy serves as the senior expert ... in advancing policy change in support of the company's business objectives. The Associate Director will proactively research and stay abreast of new strategies… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Policy Strategy and Capabilities** The Associate Director , Policy Strategy and ... reporting to the Executive Director , Policy Development & Strategy. The Associate Director will develop and maintain the strategic planning digital platform,… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with-us . **Position Summary** The Market Access/HEOR GBDS Associate Director provide statistical support to Market Access/HEOR ... to successfully enable market access and price negotiations. With appropriate experience, the Associate Director can take a lead role in the statistical aspects… more
- AbbVie (Branchburg, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Clinical Development will have global or regional ... lead, Clinical Program Lead and Clinical Science Lead and Clinical Scientist. The Associate Director , Clinical Development should expect to be asked to… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , RA Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling content… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. **Summary** The Associate Director will be responsible for developing and implementing ... global function on study and project teams + Produces independent writing for publications & regulatory documents + Serves as a specialist in PK-PD and Pop… more
- IQVIA (Parsippany, NJ)
- **Job Overview:** This position is an Associate QA Director in the Customer Strategy team who will serve as the strategic quality engagement lead for one or more ... audit plan. * Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …knowledge based upon academic training and job experience. + Strong oral and writing skill. Able to write regulatory documents in highly complex technical ... working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
