Principal Medical Writer

YOH Services LLC; United States; Remote; USD 150,000 - 165,000; Full time

Job summary

Join a forward-thinking biotech company as a Principal Medical Writer, where you'll lead a dynamic Medical Writing team. This remote role offers the chance to shape regulatory documents that impact the future of healthcare. With a focus on collaboration and innovation, you will manage complex projects and ensure compliance with FDA and EMA guidelines. If you have a passion for medical writing and extensive experience in the pharma/biotech industry, this is your opportunity to make a significant impact in a well-established organization. Embrace the challenge and contribute to groundbreaking projects that advance medical science.

Qualifications

• 8+ years of experience as a medical writer in pharma/biotech.
• Lead writer for major regulatory submissions and documents.

Responsibilities

• Lead Medical Writing department on multiple project teams.
• Write and manage complex clinical regulatory documents.
• Ensure compliance with US and international regulations.

Skills

Regulatory Writing

Clinical Study Reports

Investigator Brochures

FDA Guidelines

EMA Guidelines

ICH Guidelines

Quality Control

Project Management

Education

Bachelor's Degree

Job description

Principal Medical Writer

Category: Life Science

Employment Type: Direct Hire

Reference: BH-384355-1

*REMOTE* 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 requiring advanced regulatory writing and extensive experience in the pharma/biotech industry. Only candidates with experience working directly for a US pharma or biotech company will be considered.

Salary Range: $150,000 - $165,000

Duties include but are not limited to:

1. Serve as Medical Writing department lead on multiple project/core teams.
2. 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.).
3. Support Global Regulatory Lead with preparing information/responses requested by regulatory agencies.
4. Perform quality control (QC) reviews as necessary.
5. Interact with Quality Assurance (QA) to resolve audit findings for specific documents.
6. Maintain expert knowledge of US and international regulations, requirements, and guidance associated with regulatory documentation.
7. Coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents.
8. Manage review cycles for documents; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings.
9. Lead complex scientific key messaging/storyboarding cross-functional meetings, ensuring clarity and consistency within and across documents.

Requirements:

1. Bachelor's degree and at least 8 years of direct experience as a medical writer preparing regulated documents in the pharma or biotech industry.
2. Experience as lead writer of key documents included in major US and/or international regulatory submissions, such as clinical study reports, Investigator Brochures, clinical study protocols, marketing application summaries, INDs, NDAs, and other regulatory documents.
3. In-depth experience writing Safety sections of regulatory documents is strongly preferred.
4. Ability to independently write and complete documents to completion.
5. Extensive knowledge of FDA, EMA, and ICH guidelines, especially ICH E3 and E6.