- Merck & Co. (Rahway, NJ)
- …first-in-class or is in a new therapeutic area for our company; where no regulatory guidance exists; where the program is accelerated; has an external business ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist, Environmental Sustainability, Global Safety & Environment The Senior Specialist will report to the ... and responds to evolving environmental sustainability trends, market conditions, regulatory requirements, etc. -Evaluates and integrates the information to… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... projects under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other of our company's… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key our Company functions.Represent Device… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... teams, Brand Marketing, Training, Commercial Insights and Analytics, Managed Markets, Legal, Compliance , and Finance. The position has high exposure to senior … more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: MCAAS Innovation Lab Finance Leadership Development Program Our Finance team brings financial perspectives into overall ... is committed to developing future leaders through its Finance Leadership Development Program (FLDP). Individuals are provided with an entry point through Corporate… more
- Merck & Co. (Rahway, NJ)
- …modalities for clinical and/or commercial manufacturing would be idealExperience in regulatory compliance expectations across all phases of product development ... - Mixed Modalities, and lead a team comprised of 10-15 experienced senior and associate scientists.- The main responsibilities include leading the small molecule… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …QA Compliance , is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring accurate ... in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job Responsibilities Oversee and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: MCAAS Finance Leadership Development Program Finance at our Company is committed to developing future leaders through its ... Finance Leadership Development Program (FLDP). Individuals are provided with an entry point...to gain knowledge on products, healthcare systems, payors, and regulatory and reputational risks while working intimately with our… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... the animal facilities as well as for the veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This role is highly … more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Will utilize prior academic experience to optimize resource allocation, ensure regulatory compliance , and uphold rigorous scientific standards. Understanding ... Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include...a Tenure-Eligible Faculty member that leads their own research program as part of our collaborative research team. Tenure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies program performance in accordance with internal procedures and regulatory requirements in connection with contract testing laboratories to ensure the ... for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible… more
- Tris Pharma (Monmouth Junction, NJ)
- …materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, ... hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director,… more
- Merck & Co. (North Wales, PA)
- …development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international ... or marketed vaccines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerationsPlanning clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …company, including colleagues within the NNI Legal Department, NNI Ethics & Compliance , and Novo Nordisk headquarters, as required. May also interact with external ... with NA Privacy Office to advise on legal and regulatory privacy obligations applicable to US operations for risk...and the enhancement and maintenance of the US privacy program , including US privacy notices (cookie, HCP, employee/applicant, state… more
- Merck & Co. (Rahway, NJ)
- …approaches within Device Development and with external suppliersUnderstand and apply regulatory / compliance requirements relative to design controls and ... risk management activities.Lead the preparation of materials for program presentations for management review and regulatory submission.Contribute to the… 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, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
