- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs , including reviews/approvals of Change Control Reports ... Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) Senior Scientist… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, … more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, an Associate Principal Scientist /Associate Director, has primary responsibility for planning/managing real world and ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist /Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position** The Associate Principal Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) ... for the assigned portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals and organizational initiatives, on an… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral ... strategies and submissions for Lilly's commercial solid oral products. The regulatory scientist will be encouraged to demonstrate innovative regulatory… more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. We are seeking Regulatory Scientist GRA CMC-Parenteral Commercial Products to be a part of the Lilly ... tactical, and operational support for market registrations and post-approval submissions. The regulatory scientist will leverage CMC technical knowledge and … more
- Merck (Upper Gwynedd, PA)
- … issues to GRACS CMC management, as needed + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will ... regulatory strategies and submissions for Lilly's commercial products. The regulatory scientist will be expected to demonstrate innovative regulatory… more
- Veterans Affairs, Veterans Health Administration (Lebanon, PA)
- …VA Medical Center in Lebanon, PA. Responsibilities The Supervisory Clinical Laboratory Scientist oversees the services provided in the core laboratory and blood bank ... quality management program, and competency assessment. The Supervisory Clinical Laboratory Scientist is responsible for ensuring compliance with accrediting and … more
- Veterans Affairs, Veterans Health Administration (Miami, FL)
- …Clinical Laboratory Scientist : vacareers.va.gov/wp-content/uploads/sites/5/Total-Rewards-of-a-Medical-Technologist-Career-Flyer.pdf The ... The CLS maintains all certifications required of a clinical laboratory scientist . Applies knowledge of compliance requirements for laboratory functions. In addition… more
- Hologic (Marlborough, MA)
- …to support product positioning and market expansion. + Collaborate with R&D, Regulatory Affairs , and Marketing to integrate clinical strategies into product ... Clinical Scientist , R&D, Clinical Affairs Marlborough, MA,...working cross-functionally to generate high-quality clinical evidence that supports regulatory clearance, market adoption, and business growth. **Key Responsibilities:**… more
- Veterans Affairs, Veterans Health Administration (White River Junction, VT)
- …after complete review of the EDRP application. Responsibilities This Clinical Laboratory Scientist position is within the Pathology and Laboratory Service at the ... Vermont location. This position is Part-Time. The Clinical Laboratory Scientist (CLS) is responsible for evaluating, performing, interpreting, and validating… more
- Veterans Affairs, Veterans Health Administration (Louisville, KY)
- …Responsibilities Total-Rewards-of-an-Allied-Health-VA-Career-Brochure.pdf Clinical Laboratory Scientist (formerly Medical Technologist): ... vacareers.va.gov/wp-content/uploads/sites/5/Total-Rewards-of-a-Medical-Technologist-Career-Flyer.pdf The duties and responsibilities of the Clinical Laboratory Scientist - Generalist include but are not limited to the… more
- Veterans Affairs, Veterans Health Administration (Las Vegas, NV)
- …Total Rewards of a Allied Health Professional The Clinical Laboratory Scientist carries out the day-to-day operation in the laboratory. Develops, performs, ... accuracy of laboratory procedures and results in line with current laboratory regulatory requirements. The work is performed in a variety of laboratory specialties… more
