- Fresenius Medical Center (Lawrence, MA)
- **PURPOSE AND SCOPE:** The ** Manager , HCP Marketing** is responsible for developing and executing clinically focused marketing strategies to support the education, ... relevant content that drive product understanding and adoption. + Strong project management, communication, and analytical skills + Excellent written and verbal… more
- Edwards Lifesciences (Irvine, CA)
- …on informed consent forms (ICF). + Providing direction and guidance to execute project deliverables in collaboration with project managers. + Identifying and ... SoCRA clinical coordinator/ CRA certification) + Strong understanding of ISO 14155, FDA , and international regulatory requirements + Ability to lead and mentor field… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …affected organizations across BD. This position may provide Regulatory guidance to project teams, Operations, and/or Sales in relation to the changes. This position ... medical device and/or in vitro diagnostic and/or regulated product field + Project Management experience + Sound understanding of design control processes, FDA… more
- Sumitomo Pharma (Providence, RI)
- …Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and ... project teams, as required. + Coordinate responses to ad...and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of complex ... or more program(s), including participation in external Food and Drug Administration ( FDA ) meetings, internal core team meetings and providing technical guidance on… more
- Conagra Brands (Omaha, NE)
- …+ 5+ years of experience in plant operations within a food or FDA /USDA-regulated environment. + Project management experience. + Continuous improvement skills. + ... and achieved during qualification and verification phases. + Act as the project driver for key manufacturing initiatives, including new product introductions and… more
- US Tech Solutions (Easton, PA)
- …shipments and quantity discrepancies, including quality record ownership. + Ongoing project management focused on continuous process improvement. + Provide and ... current Good Manufacturing Practices (cGMP) and Safety compliance. + Utilizes project management skills to support Logistic Service Provider (LSP) integration and… more
- Beth Israel Lahey Health (Boston, MA)
- …correspondence (via email and phone) with all team members and external study/ project sponsors in a professional and timely manner, archiving records of ... correspondence per NIH, FDA , and/or other applicable Federal, State, and local regulations....years supervisory/management experience required. + Experience in program and/or project development and implementation. + Advanced skills with Microsoft… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …JOB DETAILS: + Provides leadership and oversight of significant clinical research project (s) with an emphasis on managing, evaluating and training research staff. + ... a knowledge of and competency in all regulatory requirements ( FDA , GCP, ICH and HIC.) MINIMUM QUALIFICATIONS: + A...Six years clinical trials research experience which includes previous project management or leadership experience. + Two years of… more
- Abbott (Alameda, CA)
- …gaps. **New Product Introduction (NPI) Enablement** + Participate in R&D and project governance meetings for seamless product launches. + Manage RFQ/RFP processes ... processes and analytics. + Ensure compliance with QMS, EMS, GMP, FDA regulations, and company policies. **Required Qualifications** + Bachelor's Degree or… more