- 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)
- …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
- 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 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
- Bristol Myers Squibb (Princeton, 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Associate Director will be responsible for supporting the development ... challenged and engaged with the broader matrix teams. The Associate Director will work with our Brand,...to ensure the program aligns with company objectives and regulatory requirements. + Conduct training sessions and produce resources… more
- Bristol Myers Squibb (Princeton, NJ)
- …and preparation of regulatory submissions. With appropriate experience, the Associate Director of Biostatistics can have responsibilities for supporting a ... their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director of Biostatistics is a member of cross-functional… more
- J&J Family of Companies (Titusville, 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... Proposition: Join our dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your expertise will play a… 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
- Bristol Myers Squibb (Princeton, NJ)
- …centralized monitoring for trials across the BMS Research & Development portfolio. The Associate Director , External Data Acquisition is a leadership role with ... directly contributes to the BMS R&D pipeline. This role reports to the Director , External Data Acquisition within GDM and is a full-time, office-based position.… 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
- System One (Basking Ridge, NJ)
- Job Title: Associate Director , Biostatistics Client: Global Pharmaceutical Company Location: Remote, US Based only - must reside in EST or CST time zones Type: ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight:… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Protocol and ICF development process with minimal guidance; including writing , reviewing, adjudication/resolution of cross functional comments and ensuring high ... clinical quality (collaboration with Medical Writing ) + Site-facing activities such as training and serving...of clinical study reports (CSRs) and clinical portions of Regulatory Documents (eg, IB, DSUR, regulatory responses)… more
- Bristol Myers Squibb (Princeton, NJ)
- …to management and development teams. + On an as-needed basis, interacts with regulatory agencies worldwide on issues of nonclinical safety evaluation. + Writes and ... globally. + Participates in discussions with internal development teams and/or regulatory agencies to address safety findings and provide safety assessments. +… more
