- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Work with cross-functional study/ project teams supporting hematology studies and interact with Clinical, Regulatory , Statistical ... meet analysis requirements, internal standard operating procedures, and external regulatory requirements. + Analyzes data and interprets results from clinical… more
- AbbVie (Cambridge, MA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. ... Oversees project -related education of investigators, study site personnel, and AbbVie...scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. +… more
- Janus Henderson Investors (Denver, CO)
- …client journey + Represent for the team in major business and regulatory change cross-functional projects, including driving implementation strategy and execution + ... Investment Product Knowledge and Story Building expertise required + Excellent project management capability: Ability to concept, direct and execute strategic… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …sustaining projects within the Advanced Access Devices (AAD) portfolio. Manage and communicate project and portfolio metrics to the AAD and MDS Leadership Teams. + ... Coach and mentor junior project managers on best practices that deliver on-time and...+ PMP certification or equivalent + Knowledge of global regulatory requirements (FDA, Anvisa, NMPA, MDR) and quality standards… more
- WTW (San Francisco, CA)
- …companies face a variety of different business, cultural, language and regulatory environments. Our Global Services and Solutions line of business helps ... contacts and local Willis Towers Watson consultants. You will serve as the project manager and day to day communication liaison with our clients, create client… more
- Charles River Laboratories (Rockville, MD)
- …position interacts regularly with key clients as well as interfaces with regulatory agencies during inspections. This position is responsible for overseeing all ... leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new production… more
- WuXi AppTec (Middletown, DE)
- …for on time Supply Chain and Master Data deliverables to support NPI project . + Responsible for the direct material standard cost setup, write-offs and crossed ... and tracking of all compliance activities (GxP as well as other regulatory requirements). Including: + Accountable for the departments related topics during audits… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …development and commercialization, go to market and launch strategy for the project (s). + Collaborate with internal and external stakeholders to align program goals ... high-quality decision making and drive cross-functional alignment. + Develop project /portfolio management tools and processes and provide strategic direction to… more
- Bristol Myers Squibb (Princeton, NJ)
- …activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives ... Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed **Skills/Knowledge… more
- Takeda Pharmaceuticals (Boston, MA)
- …related to the drug development process and into preparation for key regulatory meetings as appropriate. + Leads Clinical Operations aspects of inspection readiness ... activities and acts as subject matter expert during regulatory inspections. + Lead or participate in cross-functional strategic initiatives and process improvement.… more