- 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 the ... up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaboration with the Clinical Director.Builds talent… 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
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research ... facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology,… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director. The team is part of the Global Clinical Development ... clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Associate Directors are emerging leaders in the field of quantitative drug… more
- Merck & Co. (Rahway, NJ)
- …as immunoassays.Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development.-Working knowledge ... of regulatory guidance and quality standards, with experience authoring and...guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess...study team level including recommendations for and review of data outputs for collection of specific data … more
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based ... of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program. If you're… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, ... Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services,… 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, ... Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with internal ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Fidelity TalentSource LLC (New York, NY)
- Job Description:RoleAs a Senior Associate , you will help to provide H&W clients a different perspective by offering comprehensive solutions. These services can ... including scope control and managing projects through to conclusionCollecting and preparing data vital to analyze benefit programs while providing assistance to more… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director, HCP Marketing is responsible for developing and implementing strategic marketing programs ... progress and implementing changes to programs as needed; analysis of market data to identify key segment drivers, growth opportunities and business threats; managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills in technology systems, content creation, word processing software and data management software, and business emailing software as well as intermediate ... and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global...periodic alerts to teams to ensure that shared point data is current and accurateIn collaboration with the Head… more
