Senior Medical Writer

We are seeking a Senior Medical Writer to join our team on a contract basis. This role offers the opportunity to lead the development and delivery of clinical documentation and regulatory submissions that support the advancement of critical life-sciences programs. If you bring extensive medical writing expertise, strong leadership capabilities, and a deep commitment to clinical rigor and patient safety, we would like to hear from you.

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 Senior Medical Writer positions within clinical research and life sciences, roles that could support the delivery of evidence-based documentation across regulatory, clinical trial, and commercial channels. Positions of this type may sit within a dynamic, collaborative environment where you could drive the quality, compliance, and impact of medical communications. The work could involve partnering with clinical, regulatory, and commercial teams to translate complex trial data and safety information into clear, compliant, and compelling narratives that meet FDA, ICH, and other regulatory standards.

Typical role overview

• Location: Chicago, Illinois, USA
• Type: Contract · Full-time
• Rate: $560 - $800 per day
• Domain: Clinical / Life Sciences · Medical Writing · Regulatory Affairs

What you would do

Typical responsibilities could include:

• Leading the development of clinical study reports (CSRs), integrated safety summaries (ISS), and regulatory submissions (CTD modules, NDAs, BLAs)
• Owning the quality and compliance of medical writing deliverables across multiple therapeutic areas
• Mentoring junior medical writers and coordinating writing workflows across internal and external teams
• Managing stakeholder relationships with clinical, regulatory, and commercial partners to ensure alignment on messaging and timelines
• Maintaining expertise in FDA, ICH, and EMA regulatory requirements, including design controls and GCP compliance
• Translating complex clinical trial data and pharmacovigilance information into clear, patient-centric communications
• Driving adherence to standard operating procedures (SOPs) and data integrity protocols in all written outputs

What you could bring

Most roles of this type require the following:

Must-have

• 10–15 years of medical writing experience, with at least 5 years in a leadership or senior individual contributor role
• Demonstrated expertise in clinical trial protocols, regulatory submissions (CTD, IND, NDA, BLA), and safety reporting
• Strong knowledge of FDA, ICH-GCP, and other regulatory frameworks relevant to clinical development and commercialization
• Bachelor's degree in Life Sciences, Biology, Pharmacy, or related field (Master's degree preferred)
• Proficiency in medical writing software and document management systems
• Excellent written and verbal communication skills, with the ability to translate technical information for diverse audiences
• Authorization to work in the United States

Nice-to-have

• AMWA or EMWA certification (or equivalent professional credential)
• Experience with adaptive trial designs, real-world evidence, or patient-focused communications
• Exposure to post-market surveillance and pharmacovigilance writing
• Knowledge of therapeutic areas such as oncology, cardiology, or rare diseases

What roles of this type could offer

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

• The opportunity to shape regulatory and clinical narratives that directly influence patient access to life-changing therapies
• Scope to lead cross-functional teams and drive standards of excellence in medical writing within a regulated environment
• Exposure to complex clinical programs at critical development stages, with potential influence over submission strategy and timelines
• Professional development through engagement with current regulatory guidance, industry best practices, and peer collaboration
• A contract-based arrangement offering flexibility and the ability to work on diverse programs across therapeutic areas
• Remote flexibility where supported, combined with an in-person presence in Chicago to support team collaboration and stakeholder engagement

About Specialist Staffing Group

Specialist Staffing Group is a leading provider of specialized staffing solutions within life sciences, clinical research, and healthcare. We connect highly experienced professionals with organizations advancing treatments, diagnostics, and technologies that improve patient outcomes. Our focus is on quality, compliance, regulatory expertise, and long-term partnership with our candidates and clients.

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.