Principal Medical Writer - Clinical Focus

Job summary

The Principal Medical Writer independently plans and prepares regulatory documents and medical communications to support product development. They are responsible for analyzing, interpreting, and presenting scientific and statistical information in compliance with ICH and regulatory standards.

Job details

Job Description: Overview The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards. The Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years Flexible, inclusive culture — 70% remote workforce, 66% women-led teams Learn more about our core values here! What we offer: The estimated hiring range for this role is $142K-153K USD plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data. Benefits vary by location and may include: Remote working Flexible time off Paid holidays Medical insurance Tuition reimbursement Retirement plans What we look for: Bachelor’s degree required; science-related field preferred. Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis. Advanced knowledge of ICH and related regulatory guidelines. Excellent written English and keen attention to detail. Strong interpersonal and communication skills. Experience with Microsoft Office Suite is essential, including advanced Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process. Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

What you’ll do

The Principal Medical Writer independently plans and prepares regulatory documents and medical communications to support product development. They are responsible for analyzing, interpreting, and presenting scientific and statistical information in compliance with ICH and regulatory standards.

Requirements

Candidates must hold a bachelor's degree in a science-related field and possess at least 7 years of medical writing experience in a research setting. Advanced knowledge of ICH regulatory guidelines and strong written communication skills are essential.

Benefits

• Medical insurance
• Tuition reimbursement
• Retirement plans
• Flexible time off
• Paid holidays

Listed skills

• Attention to detail · Preferred
• Data analysis · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Medical writing
• Regulatory guidelines
• ICH guidelines
• Scientific writing
• Clinical research
• Data analysis
• Regulatory documentation
• Microsoft Office Suite
• Communication skills
• Attention to detail
• Project management
• Oncology
• Rare disease
• Regulatory Documents
• Research
• Biotechnology
• Management
• Decision Making
• Communication
• Document Production
• Marketing
• Medical Communications
• Medical Writing
• Microsoft Office
• New Product Development
• Pharmaceuticals
• Written English
• Detail Oriented

Job areas

• Healthcare
• Science & Research
• Consulting
• Medical Writer
• Authors and Related Writers
• Technical Writers

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