- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a team of GLLs, manage, develop prepare and implement regulatory documents (eg, draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC, ... Independently or through oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires ... collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical study reports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned ... EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS).… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a team of GLLs, manage, develop prepare and implement regulatory documents (eg, draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC, ... Independently or through oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with ... Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents , in collaboration with the Safety PhysicianMaintains up-to-date knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs Department, including but not limited to independent preparation of legal documents which may include AOPs and AOIs, completion of discovery and ... matters, investigating and responding to fact and document discovery, collecting documents , and responding to subpoenas and other legal document requests.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in ... direct reports.Review and interpret regulatory guidelines.Review RA and related documents for approval.Continuing Education: Keep current with regulations and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and support for the business aspects of those functions. Prepares legal documents such as contracts, correspondence (eg, to regulatory agencies), both independently ... result of such initiatives may include creating corporate-level policies, guidance documents (ie standing legal risk analyses), and training of Company employees.-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Lead and prepare FDA submissions, including but not limited to briefing documents , breakthrough therapy designation requests, orphan drug applications and BLA annual ... regulatory activities.Continuing Education: Keep current with regulations and guidance documents ; attend meetings, seminars, conferences on relevant topics; read… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Global Information Technology/DX, providing legal advice, preparing legal documents , negotiating contracts, assessing security and technical provisions. Advises ... result of such initiatives may include creating corporate-level policies, guidance documents (ie standing legal risk analyses), and training of Company employees,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as a Document Control reviewer for new and revised procedures and documents to ensure compliance with global and site proceduresSupport Document Management system ... and issuance of GMP logbooksResponsible for storage and archival of GMP documents and batch related recordsPerform tasks in a manner consistent with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position ... to the timelines.- Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …prepare FDA submissions, including but not limited to briefing documents , breakthrough therapy designation requests, orphan drug applications.Participate in global ... guidelines. Continuing Education: Keep current with regulations and guidance documents ; attend meetings, seminars, conferences on relevant topics; read journals,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and team activities. Creates and proofs packets of information; develops documents using word processing and database tools. Agreement and Payment Management: ... with legal and finance teams to ensure timely processing of documents . Monitor and manage payment schedules, approvals, and reimbursements. Ensure compliance… more
- Insmed Incorporated (San Diego, CA)
- …(CROs), and external vendors to prepare, review and finalize clinical study documents and plansContribute to scientific and operational aspects and stages of the ... of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator Brochures)Support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within the documentation reviewed per the cGMPs and SOPs on daily basisEnsure documents like batch records, labels, forms, etc. are printed and available for ... is a must.Language: English#Li-Onsite#Li-DD1Legend Biotech is a proud equal opportunity/ affirmative action employer committed to attracting, retaining, and maximizing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execute communications strategies; assist in planning, writing, and managing key message documents and talking points for key spokespeople in Global R&D research and ... industry is a plus. Daiichi Sankyo, Inc. is an equal opportunity/ affirmative action employer. All qualified applicants will receive consideration for employment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of DS Safety Notification Letter (SNL) System and presentations and documents .Electronic Data Capture (EDC) Responsibility: In conjunction with Data Management, ... and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/ affirmative action employer. Qualified applicants will receive consideration for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for execution and documentation of testing.Create, review and approve relevant QC documents , SOP's and WI's.Perform tasks in a manner consistent with the safety ... quo and conventional thinking.#Li-Onsite#Li-DD1Legend Biotech is a proud equal opportunity/ affirmative action employer committed to attracting, retaining, and maximizing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …authoring reports and co-authoring primary and secondary sections of regulatory documents . The Manager, Clinical Pharmacology is expected to identify, generate and ... and simulation required Daiichi Sankyo, Inc. is an equal opportunity/ affirmative action employer. Qualified applicants will receive consideration for employment… more
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