- Takeda Pharmaceuticals (Lexington, MA)
- …Medical, Legal, Marketing, Compliance, Labeling and Regulatory Strategy + May present regulatory topics at Ad/Promo Regulatory staff meetings and to ... topics (such as FDA enforcement trends) to Ad/Promo staff and cross-functional teams. + **Expand Cross-Functional Collaboration** -...degree such as a Master's in Life Sciences, PharmD, Regulatory Affairs (Degree or Certification), JD, or… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development ... and assures that Takeda labeling content and processes conform to regulatory requirements. **Management of Local Exceptions and LOC Interactions** + Manages… more
- Brockton Hospital (Brockton, MA)
- …and technologies for data analysis. This position requires experience in healthcare compliance, regulatory affairs , or a related field, a strong understanding of ... the organization to promote and support a culture of regulatory compliance and patient and staff safety....culture of regulatory compliance and patient and staff safety. The manager continuously seeks and introduces innovative… more
- Bristol Myers Squibb (Devens, MA)
- …Science and Technology, Business Process Management, Internal and External Manufacturing, Regulatory Affairs , Brand Teams, Legal, Patient Safety, Medical ... all cell therapy operations-spanning development and commercial programs-meet or exceed regulatory and internal quality requirements. The Head of Cell Therapy… more
- State of Massachusetts (Boston, MA)
- …of Occupational Licensure (DOL), an agency within the Office of Consumer Affairs and Business Regulation (OCABR), protects consumers by making sure the professionals ... substantive resource on questions of law or practice, trains staff , and conducts conferences and interviews. MSAC licenses all...Provide written and oral advice to the Agency on regulatory matters related to MSAC. * Establish and maintain… more
- Constellation (Everett, MA)
- …benefits package that includes bonus and 401(k). **Primary Purpose of Position** ** Regulatory Affairs ** Serve as one of the company's primary points ... regulatory compliance understanding and training **Primary Duties and Accountabilities** ** Regulatory Affairs ** 1. Develop, maintain and enhance the company's… more
- J&J Family of Companies (Danvers, MA)
- …("Voice of Investigator") to Abiomed cross-functional partners such as R&D, medical affairs , marketing, sales, and education. JOB DUTIES + Provides field support for ... investigators as defined by study-specific requirements and by the applicable regulatory code. + Maintain open communication and relationships with key site… more
- Dana-Farber Cancer Institute (Boston, MA)
- …in the clinical research field is preferred. + Experience in knowledge of regulatory affairs , research ethics, and Responsible Conduct of Research (RCR) is ... of translational research principles and biobanking processes. + Basic knowledge of regulatory affairs , research ethics, and responsible conduct of research +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …information / clinical expertise for assigned products to internal (Medical Affairs strategy teams, Therapeutic Area Units within R&D, commercial Brand teams) ... 2) medical and scientific slides housed in the Medical Affairs slide repository, and 3) other relevant publications in...* Direct and coach the Medical Information Contact Center staff on handling of "routine" cases; monitor and manage… more