- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or… more
- Eisai, Inc (Nutley, NJ)
- …milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level oversight of Clinical development plans (CDP) ... profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the...opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs),… more
- Kyowa Kirin North America (Princeton, NJ)
- …Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs, Advertising and Promotion Compliance will independently review, ... labeling material for an assigned product to ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Abbott (San Diego, CA)
- …diversity, working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our San Diego, ... RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory ...develop, and mentor regulatory professionals. Premarket: Approve regulatory filing strategies based on proposed preclinical, clinical… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at our ... location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of… more
- Bausch Health (Bridgewater, NJ)
- …and impact. The Associate Director , Regulatory Affairs handles regulatory development and post-approval/ regulatory compliance for assigned products. ... Associate Director , Regulatory Affairs Job Location: Hartford,...registrations Manage interactions with other BHC functions (eg, Quality, Compliance ) during Regulatory Authority inspections Provide … more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …true to the best of my knowledge. Job Description Senior Scientific Director , Clinical Pharmacology Boston, MA OBJECTIVES/PURPOSE The Plasma-Derived Therapies ... of Work (SOW), budget management, and invoice approvals. Engage directly with regulatory agencies, representing clinical pharmacology in global regulatory … more
- Merck & Co. (South San Francisco, CA)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...sci e ntis ts to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …proven expertise in clinical supply chain operations, project management, and regulatory compliance . They will mentor junior team members, drive operational ... days per week on average. Position Summary: The Associate Director (AD), Clinical Trial Materials (CTM) plays...compliance with GMP, GCP, GDP, and all global regulatory requirements. The ideal candidate is a seasoned pharmaceutical… more
- Seaport Therapeutics (Boston, MA)
- … regulatory inspections. Other responsibilities include the provision of regulatory compliance and QA guidance to clinical and drug safety teams, review ... GCP/GVP quality activities supporting clinical development programs, ensuring compliance with regulatory requirements and company policies. This position… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate … more
- Action Behavior Centers (Harlingen, TX)
- …and Expedited Career Growth & Leadership Tracks: Center Leadership: BCBA >Sr. BCBA>Assistant Clinical Director > Clinical Director >Sr. Clinical ... Director >Group Clinical Director >Regional Clinical Director Training & Development: Join Dr....Oversee patient assessments and develop individualized treatment plans. Ensure compliance with all regulatory requirements and best… more
- Merck & Co. (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
- Eisai, Inc (Exton, PA)
- …close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also ... Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of… more
- Merck & Co. (South San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- NYC Health Hospitals (New York, NY)
- …Visit us at www.nyc.gov/html/hhc/lincoln. Job Description Purpose of Position: The Assistant Director of Pharmacy Clinical Operations, under the direction of the ... services and programs in a hospital or hospital center. The Assistant Director will also identify, promote, and implement safe medication practices for inpatient,… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C… more
Related Job Searches:
Clinical,
Clinical Compliance,
Clinical Compliance Director,
Clinical Director,
Clinical Regulatory,
Compliance,
Director,
Regulatory,
Regulatory Clinical Compliance,
Regulatory Compliance