- Merck & Co. (North Wales, PA)
- …the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... Review (OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment-Propose creative, effective,… more
- Merck & Co. (North Wales, PA)
- … success together with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of ... regulatory leadership as needed in product in-license/due diligence review , product divestment and product withdrawal.Support new technology development.Demonstrate… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr... Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Merck & Co. (North Wales, PA)
- …Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.Participates in regulatory due ... Job DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for...approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.Mentor/instruct and provide guidance to direct reports. Review ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for ... multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Review and interpret regulatory guidelinesContinuing ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other appropriate groups within the company as needed. In collaboration with Regulatory Intelligence and Policy team members, review and interpret ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or provide information/data for regulatory filings.May serve as the single regulatory representative on study teams. Review and interpret regulatory ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review … 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
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position As Senior Medical Director for the novel modalities team, you will be part of building, leading and ... Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate ... Director .This position will have overall responsibility for oversight and...other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV)...the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance ... and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... centered around rare diseases and immune disorders. Job Summary: The Director , Development SOP Management is responsible for providing strategic direction, planning,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …we work together to change lives for the better. The Position The Associate Director , Digital Content Strategy & Production reports to the Dir, Content & Channel ... Media Marketing and related recommendations for the NNI US website. The Associate Director supports the development and evolution of NNI's content strategy in close… more
- Eisai, Inc (Nutley, NJ)
- …Continuity: Develop plans to mitigate business interruption risks.Change Management: Create a regulatory / non- regulatory change review and change management ... a difference. If this is your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the… more
