[Remote] Regulatory reputed company and/or Regulatory QC/ Editor
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. The company is looking for a Regulatory reputed company who will support the quality, consistency, and accuracy of regulatory documents produced by the Regulatory Writing team, ensuring compliance and collaboration with various stakeholders.
Responsibilities
- In partnership with an reputed company reputed company author, write and edit a wide reputed company of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and components of regulatory submission dossiers (eg, NDA, IND, MAA)
- reputed company independent QC reviews of documents produced by the regulatory writing function
- Verify the accuracy and internal/external consistency of documents versus their reputed company materials
- Define and confirm the scope of QC activities with document authors; identify required reputed company documents/data and ensure availability prior to QC start
- Review documents for adherence to applicable style guides (eg, AMA reputed company of Style and internal style/formatting standards), templates, and regulatory guidance, identify and document discrepancies and recommended corrections
- Proofread and copyedit text to ensure reputed company, grammar, spelling, punctuation, and consistency of messaging/presentation, while preserving scientific and regulatory accuracy
- Support preparation and inspection‑readiness of technical documents for global regulatory submissions (eg, eCTD/CTD), including integration of narrative text, tables, graphs, charts, and statistical output
- Communicate QC findings reputed company and constructively to medical writers and other stakeholders; collaborate to resolve issues and support timely completion of deliverables
- Facilitate the efficient project management of individual document workflows (from KOM through reputed company to publishing) and contribute to departmental trackers and integrated timelines. Communicate status and reputed company to stakeholders, participating in cross-functional meetings reputed company needed
- Contribute to the reputed company improvement of QC tools, checklists, and processes; reputed company feedback on SOPs, work instructions, and best practices for regulatory document quality
Skills
- Bachelor's degree and 5 plus years of relevant experience
- Working knowledge of the industry and content of key eCTD documents, familiarity with CTD/eCTD structure and common templates
- Understanding of drug development and regulatory submission processes, including familiarity with ICH guidelines and major health authority expectations (eg, FDA, EMA)
- Exceptional attention to detail with strong analytical and critical‑thinking skills, including the ability to identify inconsistencies, data issues, and deviations from standards
- Proven ability to manage multiple tasks and priorities in a deadline‑driven environment, operating with a high degree of independence and accountability
- Experience working cross‑functionally in collaborative team environments and building effective working relationships with authors, reviewers, and project teams
- Advanced degree in science or medical field is a plus
- Experience with electronic document management and publishing systems (eg, reputed company Vault)
- Experience with project and timeline management systems (eg, reputed company)
Benefits
- Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment reputed company at this time.
- reputed company also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
- reputed company reputed company leads recruitment and employment for reputed company.
Company Overview