- 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)
- …(data management, clinical operation and other functions) to implement clinical development plan : study ideation, protocol development, review case report from ... clinical scientists, formulate an optimal structure and a resourcing plan , and develop capabilities to serve the needs of...budget allocation, and assessment of needs including training, data review tools, etc. Standing PRG reviewer for… 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 ... (eg, Peer Reviewers, Legal Affairs reviewer , Supervisor) and discussing with other functions as needed...discussing with other functions as needed Ensure detailed peer review of medical information documents and provide appropriate and… more
- Merck & Co. (North Wales, PA)
- …aCRF; knowledge of Analysis Dataset Model (ADaM) and Analysis Data Reviewer 's Guide (ADRG) considered a plus.Excellent communication and interpersonal skills and ... the use of global outsource partner programming staff.Develop and manage project plan using Microsoft Project or similar package.Active in industry forums and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strategy, comparability plans and data governance initiativesProvide critical input and review for validation master plans, PPQ and comparability protocols and ... reportsServe as reviewer /author of a variety CMC sections or regulatory submissions,...cross-functional organization with multiple partners with competing priorities.Ability to plan , multitask, prioritize and be an effective and influential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review Plan (IDRP)- Accountable for the ... medications when needed- Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed- Study-specific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Independent Medical Education (IME) Assist in developing medical education priorities and IME plan in collaboration with IME lead Review and assist with ... and reviews IME grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of… 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 ... the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to...with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as point… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related integrated evidence generation strategies and activities as part of the USOMA Plan . Provides medical review of expanded access programs (EAP) and, ... Medical Affairs (USOMA). Develops the USOMA strategy and tactical plan as part of the US Brand Strategic ...investigator-initiated studies (IIS) as part of a US IIS Review Committee, for assigned compound. Collaborates with Global Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complex study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results ... development of optimal study design, independently develop and execute statistical analysis plan and helps in interpretation of results with some supervision. This… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …document management and data integrity. The incumbent is responsible for authoring, review and manage the development of internal procedures to ensure adherence to ... and regulatory requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and to manages a Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complex study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical Affairs strategy and execution of the Global Medical Affairs plan for select indications/projects related to evidence generation, medical information and ... Responsible for managing budgets and resources for the assigned GMA plan activities, in collaboration with Sr Director.Leads medical readiness activities for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for marketed products and is member of the Product Labelling Committee (PLC) Review Group Review /approve deliverables of the safety surveillance team Safety ... functions Conduct product training within therapeutic area of responsibility Review /approve deliverables of the safety surveillance team Chairmanship/membership of… more
- Merck & Co. (Minneapolis, MN)
- …care (transition of care) using approved messages and resources-Conducts appropriate business review of account performance to optimize net sales for our Company ... Team Leader(s), and other relevant stakeholders to develop the long-term customer plan . -Assesses competitor position as part of account plan … more
- Merck & Co. (North Wales, PA)
- …investigators, generating data displays, facilitating the internal and external review process, incorporating comments and revisions from the authors, facilitating ... in collaboration with publication specialists, and addressing comments post peer review . The Senior Scientist will participate in Publication Team meetings and… 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 increasing ... business processes and systems.Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA relevant activities including QQR, monthly quality report, team building and management review .- Involve and attend the Global QA relevant meeting and create the ... and Operations to track the objective and the mid-term plan in Global QA to ensure Global QA activities...to the system and information to do that work.- Review the QA onboarding business slides edits and updates… more
- Merck & Co. (Rahway, NJ)
- …benefit plans and programs For US and global plans and programs, draft plan documents and amendments and review employee benefit related communications, ... benefit matters Provide advice and counsel on both qualified and non-qualified plan issues with respect to company-sponsored US, Puerto Rico and international health… more
