- Genmab (Plainsboro, NJ)
- …policy.ResponsibilitiesLead the Labeling Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety ... for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and...be innovativeYou have experience working in a fast-growing, dynamic company (or a strong desire to)You work hard and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by labeling teams. Leads review processes and ensures appropriate governance for US, EU and Company Core documents as well as for the review of country labeling ... with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and company business objectives. This position manages… more
- New York life (Uniondale, NY)
- …are determined only by the terms and conditions contained in the relevant plan documents . The Company reserves the right to amend or terminate benefit plans ... York Life New York Life is a Fortune 100 company with a long history of doing good. We...families and attain their financial goals. As a mutual company , we are accountable only to our policyholders, not… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by labeling teams. Leads review processes and ensures appropriate governance for US, EU and Company Core documents as well as for the review of country labeling ... GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the… 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of fast-paced pharmaceutical manufacturing. The attorney will gain unprecedented access to Company 's senior management and becomes an integral part of building the ... Job Responsibilities: Drafting, editing, and reviewing FDA-issued regulations and Guidance documents , as well as internally developed technical documents ,… more
- Merck & Co. (San Diego, CA)
- …to generate fit for purpose AI/ML models using a combination of our Company 's proprietary data assets and public data resources, to generate novel CDx models ... can be deployed in clinical trials. You will also support preparation of regulatory documents in support of clinical trials.- In addition, you will be the site lead… more
- Merck & Co. (North Wales, PA)
- …Review Physician provides Medical consult for Medical Significance Assessments of company products as it relates to deletions, divestitures, and supply issuesMedical ... customer-centric approachReview all medical information resources and standard response documents containing product safety, tolerability and efficacy data. Interact… more
- Merck & Co. (Rahway, NJ)
- …art tools. With MIDD as an essential component of decision-making at our Company , this position offers an opportunity for the Associate Director to drive pipeline ... QP2 efforts on drug/vaccine development programs, and author or co-author strategic documents .Associate Directors are expected to have or be developing expertise in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe invite you to join our company 's mission of advancing the prevention and treatment of diseases in people and animals. In the capacity of a Global ... the labeling strategy and ensuring the development of compliant, high-quality labeling documents to facilitate the safe and effective use of our products worldwide.… more
- Merck & Co. (Rahway, NJ)
- …the art tools. With MIDD as an essential component of decision-making at our company , this position offers an opportunity for the Director to drive pipeline impact ... regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs)Required Experience:Ph.D. or equivalent degree with at… 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
- Merck & Co. (Durham, NC)
- …ensure consistent document management processes across all control documents .Coordinate responsibilities between site/functional management, site/functional SMEs and ... Documentation Management. Ability to interpret complex business and/or technical documents , write comprehensive reports and detailed business correspondence, and the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and company business objectives. This position manages ... of a team of GLLs, manage, develop prepare and implement regulatory documents (eg, draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to successful approval of pharmaceutical applications for the company 's growth, thereby accomplishing corporate goals.ResponsibilitiesLiaise, negotiate and ... all communications via contact reports.Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... patients. That's why we've been named the No. 1 company to work for in the biopharma industry in...external vendors to prepare, review and finalize clinical study documents and plansContribute to scientific and operational aspects and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources , and stability, uniting the best of both worlds ... stakeholders Perform regulatory review of all clinical and nonclinical documents for submissions, eg, clinical protocols and study reports,...longer good enough to aspire to be the best company in the world. We need to aspire to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and vendors as appropriate.- Provide clinical administrative ... study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents , TMF filing and QC activities and elevate areas of concern… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and ... Today, we are building a new kind of healthcare company - one that is ready to help create...accomplish these goals, the Senior Director may:Author detailed development documents , presentations, budgets, and position papers for internal and… more
- Merck & Co. (South San Francisco, CA)
- …and data scientists to apply cutting edge AIML approaches to leverage our Company 's investments in human genetics and other multimodal data to support drug discovery ... to best execute on programs.Clearly communicate results to project teams, our company 's scientific community, and the external scientific community through internal … more
