- Charles River Laboratories (Wilmington, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Merck (Boston, MA)
- …and focus on scientific education and dialogue + A thorough understanding of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the ... pharmaceutical industry and its customers to ensure compliance with all external and internal guidelines and standard operating procedures + Ability to organize, prioritize, and work effectively in a constantly changing environment and to motivate a team to do… more
- Pfizer (Cambridge, MA)
- …Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Strong scientific writing skills and ... communication skills (written and verbal) + Clinical document writing experience (eg, protocol, ICD, IB, IND), as well as understanding complex data analysis. + Track record of scientific productivity as evidenced by publications, posters, abstracts and/or… more
- Candela Corporation (MA)
- …the aesthetics industry (preferred) 2. Proven success launching and scaling FDA -cleared or CE-marked product technologies 3. Proficient understanding of customer ... lifecycle, buyer personas, and sales funnels 4. Demonstrated business acumen - ability to identify, plan and deliver on annual operating plan (AOP) targets and business objectives 5. Thorough knowledge of marketing principles, product marketing, and brand… more
- Bristol Myers Squibb (Devens, MA)
- …preferably with 1+ year of manufacturing site experience. Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. + ... Demonstrated experience with quality management systems + Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as… more
- Bristol Myers Squibb (Devens, MA)
- …in close proximity to strong magnets. + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred. **Basic ... Requirements:** + High school diploma and 0-2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience + Bachelors in relevant science or engineering discipline is preferred **Working Conditions:** **PHYSICAL… more
- J&J Family of Companies (Raynham, MA)
- …+ Works in accordance with all requirements for manufacturing medical devices (eg FDA QSR, ISO 9000, ISO 13485). + Completes required documentation as required by ... the process, and inspection sheets, work instructions, and document traceability. + Lifting, 5 to 25 pounds, is required on a regular basis and heavy lifting, over 50 pounds, is required on occasion. + Ability to learn and adhere to specific procedures… more
- Roche (Boston, MA)
- …Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA , EMA and other relevant guidelines and regulations is required + You ... have in-depth knowledge of cross-functional teams involved in the drug development process and can integrate multiple perspectives into the CDP. Experienced in driving various aspects of cross-functional study level strategy, eg study design, supporting… more
- Genentech (Boston, MA)
- …Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA , EMA and other relevant guidelines and regulations is required + You ... have in-depth knowledge of cross-functional teams involved in the drug development process and can integrate multiple perspectives into the CDP. Experienced in driving various aspects of cross-functional study level strategy, eg study design, supporting… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** While this position is listed as a Clinical Specialist, PLEASE NOTE that candidates that do not meet the minimum qualifications for this job as listed in the job description are still… more