- Genmab (Plainsboro, NJ)
- …onsite presence 60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key ... Prescribing Information depending on the role for the assigned product Consult with senior management to develop and communicate regulatory strategies and advice… more
- Merck & Co. (Rahway, NJ)
- …(GMPs) and other applicable worldwide regulations and our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs ... Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Merck & Co. (South San Francisco, CA)
- …as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area ... immuno-metabolic, and cardiovascular diseases to enable a robust drug discovery pipelineDrive hit/ lead finding and lead optimization plans in collaboration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position is responsible for processing and maintaining business and distribution license applications and renewals and acting as lead paralegal support ... program both within Legal and Corporate Affairs and across the Company.- Licensing and Annual Reports: Responsible for the preparation, processing, filing and… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions. Lead the Device… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our company's Research Laboratories (is committed to ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (Rahway, NJ)
- …bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our Company Research Laboratories is committed to ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (Rahway, NJ)
- …as the subject matter expert in cell line development and technical lead to represent functional area for biologic pipeline programsWork independently, including ... skills in molecular biology, systems and Synthetic biology.Experienced in regulatory filing and preparing relevant documentationExcellent oral and written… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior managementResponsibilities- Handles all legal aspects of licensing , ... senior management (including colleagues from parent company) regarding legal and regulatory aspects of major issues involving licensing and related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by senior management.Responsibilities- Acts as a brand attorney and lead legal advisor for the commercial business and operations supporting US approved ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… 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, ... regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check… more
- Merck & Co. (Rahway, NJ)
- …regarding clinical issues related to oncology compounds.-The Executive Director, PDT Lead may:-Manage Directors and/or Senior Directors responsible for Oncology ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Merck & Co. (Rahway, NJ)
- …governance (early and late stage) Provide core TMed input at external licensing committee for Cardiovascular & Respiratory. Provide clinical updates at early ... own Cardiovascular & Respiratory strategy with other TA Heads (Discovery/Late-Stage) Lead key technical reviews for Cardiovascular & Respiratory assets Conduct DRC… more
- Merck & Co. (Rahway, NJ)
- …the rights and well-being of patients; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent ... in compliance with current Good Manufacturing Practices (GMP) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around… more
- Merck & Co. (Rahway, NJ)
- …& Respiratory Therapeutic Area (CV&R). The incumbent will be expected to lead multiple programs including those new to the organization therefore requiring someone ... who has built and lead clinical development plans from the ground up. They...Section of Global Clinical Development May serve as a senior therapeutic area content expert within the company, providing… more
- Merck & Co. (Millsboro, DE)
- …documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections ... goals and evaluate performance against those goals.Serve as a member of the Senior Leadership Team for the Millsboro, DE biologics manufacturing site.Serve as the… more
