- Merck & Co. (North Wales, PA)
- Job Description Position Description: Senior Specialist , Project Management- Drug Development The Senior Specialist , Project Manager is a core member of ... develop strategies and execute our Company's drug and vaccine development efforts.The Senior Specialist is expected to provide project management leadership and… more
- Merck & Co. (North Wales, PA)
- …people to the information that they need.Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common ... integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas)… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical ... Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical… more
- Bausch + Lomb (Columbus, OH)
- …advancement of eye health in the future. **Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and ... surveillance and US regulatory licensing. **Responsibilities** + Proactively communicate CMC regulatory strategy, key issues and any other critical topics… more
- West Pharmaceutical Services (Exton, PA)
- …a healthier environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist , Regulatory Project Management (RPM) role is ... Sr. Specialist , Regulatory Project Mgmt Requisition ID:...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Novo Nordisk (Lexington, MA)
- …Are you ready to make a difference The Position The Clinical Pharmacology Specialist can be accountable for the Clinical pharmacology strategy for phase 1-4 in ... is highly cross-functional and may involve some travel. Relationships Reports to the Senior Director, Clinical Pharmacology for the US East Coast Hub. Will interact… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** ** Senior Specialist , Project Management- Drug Development** The Senior Specialist , Project Manager is a ... develop strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and… more
- Astellas Pharma (Sanford, NC)
- …For more information, please visit our website: www.astellasgenetherapies.com. **The Role:** The Senior Specialist , QC Systems Support will be responsible for ... external audits; Assists in the preparation and review of CMC regulatory submissions + Collect and report,...and training to junior colleagues **Quantitative Dimensions:** The QC Specialist IV, QC Systems Support will be responsible for… more
- Merck (West Point, PA)
- …Leadership (TPL) is seeking a highly motivated person for the role of Senior Specialist , Vaccine Technical Product Leadership. This role will provide ... promote both process and supply chain robustness across the lifecycle of the product. The Senior Specialist in the PV TPL will partner with groups across the… more
- Verista (Boston, MA)
- …in a pharmaceutical setting: + Cell and gene therapy cGMP's and associated CMC regulatory considerations + Aseptic processing + Experience successfully leading ... event investigations, Root Cause Analysis and CAPA + Experience with network-based applications such as Oracle, TrackWise + Master's degree with 2-3 years of relevant work experience, or Bachelor's degree in a scientific or allied health field with minimum 3-5… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory Departments through compliance activities and documentation related ... Regeneron is looking for a Compliance Specialist to join our Process Sciences Change Management team. This is a non-lab based position. Regeneron has successfully… more
- Merck (North Wales, PA)
- …to the information that they need. + Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common ... integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas)… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... federal and state compliance regulations. * Stays abreast of industry & regulatory changes impacting functional areas and revenue cycle. * Identifies potential… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include: Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... budget overlay in a timely manner. * Review clinical trial protocols and related regulatory documents in order to prepare a billing plan for all medical procedures… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... overlay in a timely manner. * Review clinical trial protocols and related regulatory documents to prepare a billing plan for all medical procedures and services… more