- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Review and interpret regulatory ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Teams. Responsibilities Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Regulatory Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review ... under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …minutes, and communicate materials, in support of the PSL. Independently evaluates safety data of any source to identify potential safety signals and performs safety ... development of the Safety Management Plan for assigned product(s)Independently evaluates safety data of any source to identify potential safety signals and performs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Demonstrates strong knowledge of the industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing ... procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of ...Data Analysis Based Decision-Making- Uses rigorous analyses of data as well as market supply base information for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Merck & Co. (Rahway, NJ)
- …aspects of the operational business comply with GXP legal and Regulatory Requirements and the company's Animal Health Policies and Procedures.Job ... are necessary due to audit findings.Assure maintenance of audit data in a related data system (incl....our company's Animal Health sites in their preparation for Regulatory Agency Inspections by conducting audits, "Mock Inspections", training… more
- Merck & Co. (Rahway, NJ)
- …products. Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics formulation team within Sterile Product ... the generation of experimental designs, execution of experimental plans and data analysis Support both early and late-stage development candidates, including… more
- Merck & Co. (Rahway, NJ)
- …The Associate Principal Programmer will write programs to analyze data with statistical methods which are not currently available through commercial software ... Job DescriptionPosition Description: Associate Principal Statistical Programmer - Oncology (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a… more
- Merck & Co. (Rahway, NJ)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents. Partners with Study Manager on study deliverables.Participates in ... Lead medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaboration with the Clinical Director.Builds talent and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director, Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 clinical ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Scientist, General Medicine Publications Medical Writing, works with scientists in our company's Research Labs and external ... projects and other of our Research & Development Division science. The Associate Principal Scientist is expected to collaborate with our Research & Development… more
- Merck & Co. (Rahway, NJ)
- …to the Director, Asset Management & Reliability, in this role as Associate Director Asset Management & Reliability CoE, you will be responsible for ... External Manufacturing Operations within a designated region in the Manufacturing Division.As Associate Director of Asset Management & Reliability CoE you will play… more
- Merck & Co. (Rahway, NJ)
- …drug products.Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics formulation team within Sterile and ... generation of experimental designs, execution of experimental plans and data analysisSupport both early and late-stage development candidates, including screening… more
- Merck & Co. (Rahway, NJ)
- …are deployed in support of clinical trials. The candidate for this Associate Principal Scientist position should have strong technical expertise in Liquid ... strategies in clinical trials.Writing memos, final reports and publications summarizing data , and writing/updating lab SOPs.Serve as a subject matter expert in… more
- Genmab (Plainsboro, NJ)
- …product performance, using key metrics to drive continuous improvement.Ensure that all data products comply with relevant regulatory requirements and internal ... our purpose.Reports to: Senior Director, Commercialization and Enabling Function Data ProductsJob Type: Full-TimePosition Overview: Genmab is seeking a highly… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director/Director, AR&D serves as Deputy ... Associate Director/Director, Analytical Research and DevelopmentMonmouth Junction, NJ...She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and… more
- Merck & Co. (Rahway, NJ)
- …biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory ... team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
