- 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)
- … 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)
- …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)
- …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 ... development and life cycle management. Represents the function in global regulatory /heath authorities' meetings. High-level negotiation and oversight of CROs 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
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward… more
- Merck & Co. (Rahway, NJ)
- …their results, document disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing ... Job DescriptionThe Medical Writing & Disclosure (MW&D) Department...engage in external activities to align the company with regulatory changes, act as the point of contact for… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... If this is your profile, we want to hear from you.Job Summary The Director is responsible for developing strategies for assigned product(s) and execution of HEOR 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 ... 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
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Therapy Area Head, Global Regulatory Medical Writing Date: Aug 22, 2024 Location: Parsippany, United States, New Jersey, 07005 Company: Teva ... candidate can sit anywhere in the United States** A Director , in Global Regulatory Medical Writing , reports into Head of Global Regulatory Medical… 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
- Merck (Rahway, NJ)
- …diagnostic regulations on the development and registration activities for the respective medical products. + Providing regulatory support for due diligence ... **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective,… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will ... therapeutic areas involving complex indications including rare disease/orphan conditions. The Senior Director , Medical Science - Early Stage will be responsible… more
