Principal Medical Writer

This is an opportunity to register your interest in future Principal Medical Writer roles within clinical trial documentation and regulatory communications. Roles of this type could involve leading the development of comprehensive clinical protocols and regulatory submissions that directly support patient safety and trial integrity across complex therapeutic programs.

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

About the opportunity

This is a Senior-level opportunity to register your interest in Principal Medical Writer positions, roles that could guide the strategic direction of medical writing across clinical development programs. Positions of this type may sit within a collaborative clinical operations environment where your leadership and technical expertise could shape how clinical trial protocols, regulatory submissions and safety communications are developed and delivered. The work could involve partnering across clinical, regulatory, quality and operations teams to ensure data integrity, compliance with ICH guidelines and FDA/EMA requirements, and alignment with patient safety standards throughout the clinical development lifecycle.

What you would do

Typical responsibilities could include:

• Owning the strategic development and review of clinical trial protocols, including study design rationale, endpoints and safety monitoring plans
• Leading the creation of regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs) and Common Technical Document (CTD) modules
• Guiding a team of medical writers in the production of clinical study reports, safety updates and post-market surveillance documents
• Ensuring adherence to ICH-GCP guidelines, FDA regulations, EMA guidelines and data integrity standards across all deliverables
• Managing stakeholder communications with regulatory agencies, clinical research organizations and internal cross-functional teams
• Mentoring junior medical writers and establishing medical writing standards and processes
• Contributing to the evaluation and implementation of new medical writing tools and methodologies

What you could bring

Most roles of this type require the following:

Must-have

• 10–15 years of medical writing experience in clinical development, including at least 5 years leading medical writing teams or functions
• Demonstrated expertise in clinical trial protocol development, regulatory submissions (IND, CTA, CTD) and clinical study reports
• Strong knowledge of ICH-GCP, FDA regulations, EMA guidelines, 21 CFR Part 11 and Good Laboratory Practice (GLP)
• Bachelor's degree in Life Sciences, Biology, Pharmacy or related field
• Advanced certification in medical writing (such as EMWA, AMWA or equivalent) or equivalent professional credential
• Excellent written and verbal communication skills, with the ability to translate complex clinical data into clear regulatory and protocol documents
• Proficiency in medical writing software and document management systems
• Authorization to work in the United States

Nice-to-have

• Master's degree in a life sciences or regulatory affairs discipline
• Experience with therapeutic areas such as oncology, cardiovascular or immunology
• Familiarity with electronic data capture (EDC) systems and clinical data management
• Knowledge of post-market surveillance and pharmacovigilance reporting

What roles of this type could offer

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

• Permanent, full-time employment with a salary range of $130,000–$190,000 per annum, dependent on experience and qualifications
• Meaningful involvement in clinical programs that directly support patient safety and therapeutic advancement
• Leadership opportunity to mentor and develop medical writing talent
• Scope to shape organizational standards, processes and best practices in medical writing and regulatory strategy
• Professional development support, including conference attendance and continuing education in regulatory affairs and clinical development
• Comprehensive benefits package, including health insurance (medical, dental and vision coverage), paid time off, 401(k) retirement plan, flexible work arrangements and professional memberships
• Collaborative, collegial work environment based in Chicago, Illinois

About Specialist Staffing Group

Specialist Staffing Group connects talented clinical and life sciences professionals with organizations shaping the future of healthcare and therapeutic development. We partner with leading healthcare, pharmaceutical and medical device companies to build teams that advance patient outcomes and drive innovation. Our mission is to help professionals like you find roles where your expertise, experience and ambition can have real impact.

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.