- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...strategic insights at the study team level. The Associate Director of Regulatory Writing must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …staff in the creation of the development strategy ensuring the highest scientific/ medical standards in accordance with ethical and regulatory requirements across ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...are managing a team of clinical scientists for the writing of protocols / amendments and associated documents (… 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 ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … documents (eg, response to HAs, briefing book, etc.) in conjunction with Medical Writing - Leads scientific components of IM (Investigators Meeting) and SIV ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and represents global function on study and project teams.Produces independent writing for publications and regulatory documents.Serves as a specialist ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of sourcing strategies for a specific set of R&D categories (CRO, Medical Writing , BDM, etc..). Builds strategic plans for specific categories ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations. In… more
- J&J Family of Companies (Trenton, NJ)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory ... people can reach their potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a highly experienced … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology ... contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory Writing...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Job Summary:** The Associate Director of Regulatory Writing is a key role responsible ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...strategic insights at the study team level. The Associate Director of Regulatory Writing must… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …of bipolar depression in adults as monotherapy and as adjunctive therapy. The Associate Director / Director of Medical Writing provides support for the ... Regulatory documents, and responses to health authority information requests. The Associate Director / Director of Medical Writing must have experience… 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
- Integra LifeSciences (Princeton, NJ)
- …challenging what's possible and making headway to help improve outcomes. The ** Director of Post Market Surveillance** is responsible for developing, directing and ... and Post Market Surveillance activities required for EU MDR and other global regulatory bodies. This role will establish a Post Market Surveillance program that… more
- J&J Family of Companies (Titusville, NJ)
- …Global Development (clinical trial startup, performance, oversight, and results reporting), Medical Writing (document templates and clean authoring), Therapeutic ... At least 10 years' of relevant pharmaceutical/scientific experience (in clinical development or medical writing preferably) + At least 10 years' of people… more
- AbbVie (Branchburg, NJ)
- …medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Clinical Development will have global or regional responsibilities and… more
- Marriott (Trenton, NJ)
- …**Position Type** Management **JOB SUMMARY** Marriott has an exciting opportunity for a Director on the Corporate Systems team within the Finance domain. This role ... owning technology and supporting Marriott's critical enterprise applications. The Director , Financial Systems will lead the strategic design, implementation, and… more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Associate Director will be responsible for supporting the development and ... for the management of the program and will report directly to the Director , Patient Access & Support Services. This individual will be responsible for creating… more
