We are looking to add experienced medical writing talent to our database for future Lead Medical Writer opportunities in the clinical and life sciences sector. These roles would typically involve guiding regulatory submissions, clinical trial documentation and medical communications strategy at a senior level, with scope to mentor teams and shape medical writing standards across complex therapeutic programs. 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 medical communications. Roles of this type could support the delivery of critical regulatory submissions, clinical trial protocols and safety documentation that directly impact patient outcomes and regulatory compliance. You would typically work within cross-functional teams across clinical operations, regulatory affairs and commercial functions, translating complex clinical and scientific data into clear, compliant medical documentation. Typical role overview

Location:

Chicago, Illinois, United States Type:

Contract

Full-time Rate:

$560 - $800 per day

Domain:

Clinical development

• Medical writing
• Life sciences
• Regulatory compliance What you would do Typical responsibilities could include: Leading the development and delivery of regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs) and New Drug Applications (NDAs) Owning the creation and strategy for clinical trial protocols, study safety reports and integrated safety summaries Coordinating medical writing across multiple therapeutic programs, ensuring consistency with regulatory requirements and company standards Guiding junior medical writers and contributing to the professional development of writing teams Managing stakeholder relationships across clinical operations, regulatory, quality assurance and medical affairs Ensuring data integrity, GCP compliance and adherence to FDA, ICH and international regulatory guidelines Mentoring teams on best practices in medical writing, regulatory language and documentation standards Driving improvements to medical writing processes, templates and quality assurance protocols What you could bring Most roles of this type require the following: Must-have 10-15 years of medical writing experience, with a minimum of 5+ years in a lead or senior medical writing role Extensive experience writing regulatory submissions (IND, CTA, NDA, BLA or equivalent international submissions) Advanced knowledge of FDA regulations, ICH guidelines, GCP and clinical trial design Proven expertise in clinical trial protocols, safety reports and integrated safety summaries Bachelor's degree in Life Sciences, Biology, Pharmacy, or related field Excellent written and verbal communication skills with the ability to translate complex clinical data into clear regulatory language Proficiency with medical writing software, document management systems and regulatory databases Authorization to work in the United States Nice-to-have Master's degree in regulatory affairs, pharmacy, or life sciences AMWA (American Medical Writers Association) certification or equivalent professional credential Experience with electronic submissions and eSTAR systems Background in a specific therapeutic area (oncology, cardiology, rare disease, etc.

) Experience leading cross-functional medical writing teams Knowledge of post-marketing safety documentation and pharmacovigilance 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 directly influence regulatory strategy and patient access to critical therapies Leadership scope across complex, multi-program medical writing initiatives Mentorship and professional development opportunities within growing clinical teams Exposure to cutting-edge therapeutic areas and regulatory challenges The ability to shape medical writing standards and best practices across programs Contract flexibility with potential for extension based on program needs Involvement in high-impact submissions that support patient safety and regulatory compliance Access to continuing professional development and industry networking opportunities About Specialist Staffing Group Specialist Staffing Group partners with leading organizations across clinical development, regulatory affairs and life sciences to connect experienced professionals with meaningful opportunities. We specialize in medical writing, regulatory, quality and clinical talent, supporting the delivery of safe, compliant therapeutics that reach patients who need them. 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.