- Takeda Pharmaceuticals (Lexington, MA)
- …indicators to Leadership. + Maintains current and up to date knowledge on FDA Regulations and Guidance documents and enforcement action letters as applicable to ... promotional claims and shares implications with Medical Reviewers to enhance the team's knowledge, understanding, and awareness of best practices. + Supports the development of (Sr) Medical Information & Review Managers by supporting training activities to… 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) + Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations. + Experience working with and solid understanding of related disciplines, eg, Clinical Operations,… more
- BD (Becton, Dickinson and Company) (Woburn, MA)
- …Engineering + Preferred Experience in validation and process controls + Preferred FDA regulation experience + Preferred Experience with ISO 13485 and 21CFR PART820 ... At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per… more
- Takeda Pharmaceuticals (Lexington, MA)
- …experience and accomplishments. + Proficiency in cGMP Engineering within FDA -regulated industries (pharmaceutical or biotechnology) and strong understanding of Good ... Engineering Practices (GEP). + Expertise in automation systems (eg, Allen Bradley, Siemens PLC, DeltaV DCS, iFix, SCADA systems) and data/integration solutions (eg, PI, OPC, WebAPI) with knowledge of instrumentation and industrial control networks (Ethernet… 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** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill, and/or… more
- Cardinal Health (Boston, MA)
- …investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, including ... any MSL presentations and Medical/Safety Review Committees + Provides pharmacovigilance support through collaboration with other internal stakeholders by collecting adverse event information, facilitating investigations of safety events, and identifying… more
- Medtronic (Boston, MA)
- …of similar complexity) program management and implementation Experience working with US FDA , EU Notified Bodies and/or other regulators during the review of ... technical documentation Demonstrated ability for strategic thinking, project planning and project management Experience driving initiatives and change management Strong influence management skills. Demonstrated ability to work cooperatively at all levels in an… more
- Charles River Laboratories (Boston, 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
- Sumitomo Pharma (Boston, MA)
- …and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of ... medical review of Individual case safety reports and aggregate safety reports + Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + Experience managing safety data, expedited individual… more
- Teleflex (Chelmsford, MA)
- …processsing changes. * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures and ... processes. * Support internal and external audits as needed. * Back up support for the traning function. * Performs other related duties and responsibilities as assigned. * Support site goals and objectives. * Other duties as assigned. **Education / Experience… more