Technical Writer - The Fountain Group
Bridgewater, NJ
About the Job
The Fountain Group is currently seeking a Technical Writer (hybrid/remote) for a prominent client of ours. This position is located in Bridgewater, NJ or Boston, MA. Details for the position are as follows:
Location Details:
Location Details:
- Must be local to BRIDGEWATER, NJ or BOSTON, MA
- Bridgewater, NJ:
- Local NJ candidates will work on a HYBRID schedule after training (2 days onsite)
- Boston, MA:
- Local MA candidates will be required to travel onsite to Boston for a few days during the initial months for training
- FULLY REMOTE after training
- Travel is NOT reimbursed
- 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.
- They coordinate directly with key stakeholders within company’s industrial network, and with external partners (contract manufacturing organizations (CMOs), and alliance partners).
- Key Responsibilities:
- 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).
- They define and manage the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
- Identify potential regulatory risks/challenges while ensuring regulatory compliance.
- Author autonomously the CMC sections of dossiers using templates and source documentation in accordance with Common Technical Document (CTD) guidance and company standards.
- Ensure delivery of sections in a timely manner.
- Manage the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
- Perform life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
- Maintain an up-to-date knowledge of company’s ways of working and SOPs and develops a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
- Author other types of regulatory documents such as white papers, position papers, and briefing book.
- In parallel, the technical writer could help support non regulatory writing projects such as SOP and technical documents throughout the department.
- BS (bio-related or pharma degrees only)
- Local to Bridgewater, NJ (hybrid – 2 days onsite - after training) or Boston, MA (remote after training)
- 5+ years of relevant industry experience
- 3+ years authoring AND writing CMC or CTD modules within pharma
- Life-cycle tools (Veeva or Documentum)
- Microsoft Office (MS Word + MS Excel)
- Regulatory Affairs / CMC background preferred
Source : The Fountain Group
