• Associate Director

    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
    Daiichi Sankyo Inc. (09/05/24)
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  • Associate Director / Director

    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
    Intra-Cellular Therapies, Inc (08/27/24)
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  • Associate Director , Global…

    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
    Bristol Myers Squibb (08/14/24)
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  • Associate Director , Policy Advocacy

    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 (09/14/24)
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  • Associate Director , Policy Strategy…

    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
    Merck (09/14/24)
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  • Associate Director , MA/HEOR…

    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
    Bristol Myers Squibb (09/05/24)
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  • Associate Director , Clinical…

    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
    AbbVie (09/12/24)
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  • Associate Director , RA Labeling…

    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
    J&J Family of Companies (08/10/24)
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  • Associate Director , Clinical…

    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
    Daiichi Sankyo Inc. (08/22/24)
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  • Associate Director of Quality…

    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
    IQVIA (09/05/24)
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  • Senior Scientist / Associate

    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
    Daiichi Sankyo Inc. (08/22/24)
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  • Associate Director , Biostatistics

    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
    System One (09/05/24)
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  • Senior Clinical Scientist-Immunology…

    Bristol Myers Squibb (Madison, 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 (08/24/24)
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  • Scientific Associate Director

    Bristol Myers Squibb (New Brunswick, 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
    Bristol Myers Squibb (09/09/24)
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  • Associate Director , Drug Safety

    Merck (Rahway, NJ)
    …both a system and process prospective. + Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits. + Lead efforts ... with International Pharmacovigilance community and external customers to ensure regulatory compliance for both expedited and periodic reports. + Collaborate… more
    Merck (09/10/24)
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  • Associate Director - Derivatives…

    MetLife (Whippany, NJ)
    …markets; the derivative instruments used to manage risk; and the accounting and regulatory environment of both insurance companies and asset managers. They will work ... experience a plus * Experience developing hedging solutions a plus * Experience writing about derivative markets and strategy a plus * Masters of Business… more
    MetLife (06/29/24)
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  • Associate Director , R&D Procurement…

    Daiichi Sankyo Inc. (Basking Ridge, 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 strategy… more
    Daiichi Sankyo Inc. (08/08/24)
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  • Associate Director , Biostatistics

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. + CRO / Vendor ... 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. (07/18/24)
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  • Associate Director , Biostatistics…

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. + CRO / Vendor ... 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. (07/08/24)
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  • Director Biologics and Biopharmaceutics

    Merck (Rahway, NJ)
    …, Operations, Non-clinical, Clinical, and other functional areas + Experience 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 (09/08/24)
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