- Novo Nordisk Inc. (Plainsboro, NJ)
- …a medical/scientific standpoint. Serve as a member of the Promotional Review Board (PRB). Additional responsibilities may include convention planning/staffing, sales ... Acts as a formal or informal mentor to others in Medical Promotional Review ; may oversee PharmD Fellow(s) on a rotational basis. Essential Functions Provide critical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Field ForceOn Board new hires for Commercial team (in-house and field-based)1. Review processes/systems used and complete training, when necessarya) TCP (time off ... to identify attendees for each congressc) Meet weekly with vendor to review registrations and hotel reservations for attendeesd) Track updates and communicate in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... group and across the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to achieve high quality and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position will be responsible for supporting the global Cross Border Engagement Review (CBER) process and will also serve as the initial reviewer for all ... approvers, and CBER Steering Committee members to coordinate the submission and review of Cross Border Engagements. Additionally, this role will consult with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and reviews IME grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of ... Serve as NNI Medical Affairs representative on Medical & Science Team Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …global alignment of medical information standards and best practices. Medical Promotional Review (option) Gain an understanding of Medical Promotional Review and ... accuracy, as well as consistency with the FDA-approved labeling. Assist the Promotional Review Board (PRB) team to ensure all promotional materials (ie , consumer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review ... medications when needed- Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed- Study-specific… more
- Merck & Co. (Durham, NC)
- …for establishing processes that ensure required safety guidelines are followed.- Review and approve qualification/validation documents for equipment and process (ie, ... IQ/OQ/PQ). Review and approve Performance Qualification documents pertaining to environmental...orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. -… more
- Merck & Co. (Durham, NC)
- …status (eg, problem and incident management, change control, periodic review , investigations, backup/restore, System Use and Administrative SOPs (including ... sufficiently detailed electronic data review /audit trail review instructions for users), disaster recovery plans, business continuity plans). Review … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the ... medications when neededAddresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from healthcare professionalsOversee the timely execution of the development, review and approval process incorporating input/recommendations from other reviewers ... and discussing with other functions as needed Ensure detailed peer review of medical information documents and provide appropriate and effective… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the assessment ... medications when neededAddresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject… more
- Merck & Co. (North Wales, PA)
- …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... objectives.Serve as the liaison and manages correspondence with FDA's promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health ... for QA activities for internal and external oversight.Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complex study problems.Responsibilities:Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results ... low to medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, data surveillance review ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …input into study protocol profiles, final protocols and amendmentsLead document review & coordination for the protocol and amendments. Additional medical writing ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Merck & Co. (Rahway, NJ)
- …with internal and external reviewers, and guiding the posting through review and approval. Collaborating with clinical teams, including requesting necessary data ... Regulation of the European Union). Responding to internal and clinical review comments on public disclosures; amending disclosures as appropriate and incorporating… more
- Merck & Co. (Rahway, NJ)
- …subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation. Provides ... approval according to the committee charters (including therapeutic area Document Review Committees, Product Development Team, Early Development Team, and label… more
- Merck & Co. (Rahway, NJ)
- …and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated ... coordinates cross-functional regulatory support for development programs and marketed products. Review and provide final approval of local registration study… more
- Merck & Co. (North Wales, PA)
- …customer segments and commercial programs.Maintains working knowledge of promotional review systems and regulatory guidance to effectively deliver compliant ... and external support services through content creation, design, commercial legal review , promotional review (OneReview), production, and deployment.Manages the… more
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