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US Company

Associate Director, Medical Writing (Regulatory) Job at US Company in Redwood Ci

US Company, Redwood City, CA, United States, 94061

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The Associate Director, Medical Writing (Regulatory) will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions. This position will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents. This is an hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities:

  • Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions
  • Plan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions, meeting requests, briefing books, annual reports/development safety update reports (DSURs)
  • Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports
  • Provide oversight of document quality and consistency for ease of review across multiple documents assembled in a regulatory dossier or briefing package
  • Lead document review and comment resolution processes with cross-functional teams
  • Leverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, briefing books and annual reports
  • Coordinate the review and approval of documents
  • Develop templates, style guidelines, and SOPs for regulatory documentation
  • Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements

Preferred Education and Experience:

  • JD/Paralegal degree with scientific background or advanced scientific degree (MS, PhD or PharmD)
  • Regulatory medical writing experience in the pharmaceutical industry/CRO environment or equivalent experience writing technical materials for submission to regulatory authorities, legal entities and/or other audiences
  • Able to compile, analyze, and present data clearly, concisely, and effectively
  • Experience participating in submissions to the US FDA (IND, NDA) and EMA (MAA)
  • Strong understanding of drug development and regulations (US, EU and ICH)
  • Broad knowledge of relevant regulatory guidelines (e.g., FDA, EMA) and compliance requirements
  • Proficiency with Electronic Common Technical Document (eCTD) templates
  • Strong verbal and written communication skills to effectively collaborate with cross-functional teams and address regulatory queries

The pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $212,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

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