Principal Medical Writer

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-384355

PRINCIPAL MEDICAL AND REGULATORY WRITER
Excellent opportunity to join a newly formed Medical Writing team at a well-established biotech company in San Diego County. The Principal Medical and Regulatory Writer will be assigned to projects that require advanced regulatory writing and requires extensive experience in the pharma/biotech industry. Only candidate with experience working directly for a US pharma or biotech company will be considered for this role.
Salary Range: 150-165K
Duties include but are not limited to:

• Serve as Medical Writing department lead on multiple project/core teams.
• Lead, write, and manage complex clinical regulatory documents (e.g., clinical study reports, Investigator Brochures, clinical study protocols, briefing documents, marketing application summary documents [Module 2], etc.).
• Support Global Regulatory Lead with preparing information/responses requested by regulatory agencies.
• Perform quality control (QC) reviews as necessary.
• Interact with Quality Assurance (QA) to resolve audit findings for specific documents.
• Maintain expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
• Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents
• Manage review cycles for documents; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings.
• Lead complex scientific key messaging/storyboarding cross-functional meetings, ensuring the messages are clear and consistent within and across documents.

• Bachelor's degree and a minimum of 8 years of direct experience as a medical writer preparing regulated documents in the pharma or biotech industry are required.
• Experience as lead writer of key documents included in major US and/or international regulatory submissions comprising, but not limited to clinical study reports (all sections including safety narratives), Investigator Brochures, clinical study protocols, marketing application summary documents, Investigational New Drug applications, clinical sections of New Drug Applications, and other regulatory documents (e.g., Briefing Documents).
• In depth experience writing Safety sections of regulatory documents strongly preferred.
• Ability to independently write and complete documents to completion is required
• Extensive working knowledge of relevant FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6.