- J&J Family of Companies (Danvers, MA)
- …building with study steering committee and principal investigators and communication with FDA + Work closely with biostatistics team to evaluate study design options ... and analyze study data to support study decisions related to protocol development and study execution + Support the production of trial-related interim analyses, hypothesis testing, publications, and presentations + Own steering committee meetings and serve as… more
- Genentech (Boston, MA)
- …programming in support of regulatory submissions and compliance expectations (eg, FDA , EMA) + You bring strong cross-functional collaboration and communication ... skills within a matrix organization + You have experience leading a global team and/or organization + You have experience with automation, metadata-driven design, or digital programming environments (an advantage) + You are fluent in English and willing to… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …+ Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Expertise in LMS administration, data analyics, and process ... optimization. + Excellent communication, stakeholder management, and project leadership skills. **Preferred Attributes:** + Strategic thinker with a passion for scientific learning and development. + Agile and adaptable in a fast-paced, matrixed environment. +… more
- Cytel (Cambridge, MA)
- …Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to detail, ... analytical problem-solving, and ability to manage multiple projects simultaneously. + Effective communication skills and experience collaborating in matrixed research environments. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are… more
- 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …+ Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs ... using adult learning principles. + Experience with learning technologies (eg, LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder engagement skills. **Preferred Attributes:** +… more
- Bristol Myers Squibb (Devens, MA)
- …with 2+ year of QA shop floor experience. Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred."Project management ... experience is preferred. **Working Conditions:** PHYSICAL /MENTAL DEMANDS: + Able to work near strong magnetic fields. + Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.). **BMSCART** **\#LI-ONSITE**… more
- J&J Family of Companies (Danvers, MA)
- …electronics, electromechanical integration, and embedded platforms. + Strong understanding of FDA design control, ISO 13485, and risk management practices. + ... Demonstrated ability to lead cross-functional engineering teams and deliver complex programs. _Preferred:_ + Master's or Ph.D. in Engineering or related technical discipline. + Experience with life-sustaining devices or critical care capital equipment. +… more
- Dana-Farber Cancer Institute (Boston, MA)
- …compliance standards, with expertise in Good Clinical Practice (GCP) and FDA regulations. + Familiarity with project management methodologies and strategic planning, ... tailored to clinical trial environments. + Advanced organizational skills to manage multiple complex projects simultaneously, ensuring compliance and efficiency in trial execution. + Strong leadership and team coordination skills to guide research teams, with… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Expert knowledge of federal regulations regarding human subject research protections, FDA and ICH Good Clinical Practices. **Pay Transparency Statement** The hiring ... range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range… more