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Regulatory Technical Writer
1 month ago
The Fountain Group are a national staffing firm and are currently seeking a Regulatory Technical Writer (Module 2-3 CTD) for a prominent Pharmaceutical client of ours. This position can be in either Bridgewater, NJ or Boston, MA. Details for the position are as follows:
Job Description:
- Pay: 41.00-51.00/hr.
- Length of Assignment: 1 year to start with potential to extend or convert.
- Candidates can sit in either location: Bridgewater, NJ candidates: hybrid schedule (2x week). Boston, MA candidates: in-person training, fully remote after.
- Must-Have Experience with authoring Module 2 and 3 CTD sections (from scratch or updates), VEEVA, Microsoft Word & Excel.
- The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
- Coordinates directly with key stakeholders within industrial network, and with external partners (contract manufacturing organizations (CMOs), and alliance partners).
- The technical writer contributes to various US, EU, and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations, and other communications with regulatory authorities (e.g., briefing documents for meetings).
Browse our website below for additional information on our company.
The Fountain Group
4505 Woodland Corporate Blvd, Tampa, FL 33614
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r
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Browse our website below for additional information on our company.\r
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The Fountain Group\r
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4505 Woodland Corporate Blvd, Tampa, FL 33614\r
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”