Lead Medical Writer

Lead Medical Writer positions in clinical and life sciences could involve directing the development and delivery of comprehensive medical documentation across regulatory, clinical trial, and commercial channels. These senior-level opportunities could focus on ensuring scientific accuracy, regulatory compliance, and patient safety through expert-led medical communication strategy.

Please note the content of this advert does not represent a live vacancy.

About the opportunity

This is an opportunity to register your interest in future Lead Medical Writer positions within clinical development and life sciences, roles that could support the delivery of accurate, compliant medical documentation that advances patient safety and regulatory success.

Roles of this type may sit within a dynamic, collaborative team environment where medical writing expertise directly influences regulatory submissions, clinical trial protocols, and cross-functional stakeholder communication. The work could involve leading medical writing strategy, mentoring junior writers, and partnering with clinical, regulatory, and commercial teams to translate complex scientific data into clear, compliant documentation that meets FDA, ICH, and organizational standards.

Typical role overview

• Location: Chicago, Illinois, USA — flexible work arrangements available
• Type: Permanent · Full-time
• Salary: $130,000 - $190,000 per annum, dependent on experience
• Domain: Clinical development · Medical writing · Life sciences · Regulatory compliance

What you would do

Typical responsibilities could include:

• Directing the development of clinical trial protocols, investigator's brochures, and study-related documentation that meet ICH-GCP and regulatory standards
• Leading the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and post-marketing safety reports to FDA and international authorities
• Mentoring and supervising a team of medical writers, providing guidance on scientific accuracy, regulatory compliance, and writing standards
• Partnering with clinical, regulatory, quality, and commercial teams to ensure medical documentation aligns with study objectives and regulatory requirements
• Establishing and maintaining medical writing standards, templates, and quality assurance processes
• Managing complex medical writing projects with multiple stakeholders and competing timelines
• Ensuring all documentation maintains the highest standards of data integrity, patient safety messaging, and compliance with GCP, GMP, and relevant regulations

What you could bring

Most roles of this type require the following:

Must-have

• 10–15 years of medical writing experience, including 5 years in a lead, senior, or mentoring capacity
• Demonstrated expertise in clinical trial documentation, regulatory submissions (IND, NDA, BLA), or comparable medical writing within life sciences
• Advanced degree in Life Sciences, Biology, Pharmacy, or related field; or equivalent professional medical writing certification (EMWA, AMWA credentials valued)
• Deep working knowledge of FDA regulations, ICH guidelines, GCP standards, and regulatory pathways for drug development
• Proven track record of leading teams, mentoring junior writers, and establishing medical writing processes and standards
• Strong project management skills with the ability to manage multiple complex submissions and stakeholder priorities simultaneously
• Authorization to work in the United States

Nice-to-have

• Experience with electronic submission formats (e-STARs) and regulatory tracking systems
• Background in specific therapeutic areas (oncology, cardiology, rare disease, etc.)
• Experience with post-marketing surveillance, pharmacovigilance, or safety reporting
• Advanced project management or leadership certification

What roles of this type could offer

Most roles of this type offer the following, dependent on the industry and seniority of the role:

• Opportunity to lead high-impact medical documentation that advances patient safety and regulatory compliance in drug development
• Scope to mentor and develop junior medical writers, contributing to career progression within the organization
• Access to continuing professional development, including conference attendance, certification support, and advanced regulatory training
• Potential for progression toward principal or director-level responsibility in medical writing leadership or strategic regulatory affairs
• Competitive permanent employment with comprehensive benefits including medical, dental, and vision coverage, paid time off, retirement planning (401k), flexible work arrangements, and professional development support

About Specialist Staffing Group

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How to register interest

If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career.

Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.