- ThermoFisher Scientific (Greenville, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** FSP Senior ** ** Regulatory ** ** Medical Writer (** ... seeking candidates based in the US! As a remote-based Senior Medical Writer within the FSP...possess the versatility to author both clinical and preclinical regulatory documents, with therapeutic area expertise in infectious diseases… more
- IQVIA (Durham, NC)
- **Job Level:** Senior Biostatistician, FSP **Location:** Home-based in the US or Canada **Why DSSS?** Data Sciences Staffing Solutions, DSSS or DS3, is a unit ... provides our sponsors with fully embedded resources through a Functional Service Provider ( FSP ) partnership. This means you get all the benefits of working for an… more
- IQVIA (Durham, NC)
- **Job Level:** FSP Senior or Principal Biostatistician for Early Phase Clinical Development (PK) **Location:** Home-based in the US or Canada **Why DSSS?** Data ... with fully embedded resources through a Functional Service Provider ( FSP ) partnership. This means you get all the benefits...expertise. + Contribute to clinical study reports and other regulatory documents eg, DSURs, IB, etc. + Support exploratory… more
- ThermoFisher Scientific (Wilmington, NC)
- …site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all ... and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate)… more
- IQVIA (Wayne, PA)
- …results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers. + Lead effective communication ... in both secondary database studies and primary data collection, including electronic medical record and/or medical claims databases + Specifically, experience… more
- ThermoFisher Scientific (Greenville, NC)
- …with Indication Development Teams and cross-functional partners, including Trial Operations, medical affairs, regulatory affairs, global patient advocacy, and ... (GloSAM). Ensure alignment of recruitment strategies with study protocols and regulatory requirements. Provide coaching and mentoring to other team members Provide… more
- Bristol Myers Squibb (Princeton, NJ)
- …BMS clinical trials from study start to database lock. **Position Summary** The Senior Manager, Clinical Data Management is a leadership role considered essential to ... and audits + Provides coaching and quality oversight of junior Data Management Leads ** FSP /CRO/Vendor Oversight** + May act as core member of the study team and… more
- Vitalief (New Brunswick, NJ)
- …we deliver consulting (both operational and strategic) and Functional Service Provider ( FSP ) solutions that empower organizations to do more with less, streamlining ... that ultimately benefit patients. We are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully… more
- ICON Clinical Research (Blue Bell, PA)
- VP, Business Development FSP & Blended Solutions - US and UK - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're ... Business Development at ICON, you will play a pivotal role in leading FSP strategic initiatives and blended solutions to drive growth, expand market presence, and… more
- ADM (Decatur, IL)
- …Ability to communicate and interact with all levels of the organization, including senior management, customers, and regulatory officials as needed. + In depth ... the corporate food safety programs (Foreign material, pest control, EMP, GMP, PRP, FSP /HACCP etc.). You will work with different business unit to define and… more