This is an opportunity to register your interest in Principal Medical Writer roles within clinical research and life sciences organizations. Roles of this type focus on developing regulatory and clinical documentation that supports the approval and safe delivery of therapeutic innovations, working with cross-functional teams to translate complex clinical data into clear, compliant communications. Please note the content of this advert does not represent a live vacancy. About the opportunity Roles of this type typically sit within clinical development, regulatory affairs, or medical communications teams at organizations advancing therapeutics through clinical trials and regulatory submissions. The work could involve owning the development of clinical trial protocols, regulatory submissions, clinical study reports, and patient-facing materials, with scope to guide junior writers, establish documentation standards, and shape how clinical evidence is communicated to regulators, healthcare professionals, and patients. Typical role overview

Location:

Chicago, Illinois, USA Type:

Contract Rate:

$560 - $800 per day

Experience:

10-15 years in medical writing and clinical documentation

Domain:

Clinical research

• Regulatory submissions

• Life sciences What you would do Typical responsibilities could include: Owning the development and regulatory review of clinical trial protocols, safety reports, and clinical study reports Driving the creation and submission of regulatory documentation including INDs, NDAs, and BLAs in compliance with FDA and ICH guidelines Leading the translation of complex clinical trial data into clear, accurate regulatory narratives Mentoring and guiding junior medical writers on documentation standards, regulatory requirements, and writing best practices Coordinating with clinical operations, biostatistics, medical affairs, and regulatory teams to ensure data accuracy and regulatory compliance Establishing and maintaining medical writing standards, templates, and governance across clinical programs Managing stakeholder review cycles and incorporating feedback from regulatory, clinical, and compliance teams Ensuring patient safety and data integrity throughout all written documentation What you could bring Most roles of this type require the following: Must-have 10-15 years of professional medical writing experience in clinical research or regulatory affairs Demonstrated expertise in developing clinical trial protocols, regulatory submissions (INDs, NDAs, BLAs), and clinical study reports Working knowledge of FDA regulations, ICH guidelines, and Good Clinical Practice (GCP) standards Experience with clinical trial design, data management, and statistical reporting Proven ability to lead and mentor junior medical writers or communications professionals Advanced degree in life sciences, biology, pharmacy, or related field (Master's or PhD preferred) Authorization to work in the United States Nice-to-have AMWA or EMWA certification or equivalent professional credential Experience with electronic submissions and regulatory intelligence platforms Knowledge of specific therapeutic areas (oncology, cardiology, immunology, etc.) Experience in patient-centered communications and Plain Language compliance 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 influence the regulatory pathway for therapeutics that reach patients Scope to shape clinical documentation standards and establish best practices across programs Potential for progression toward Principal or Senior leadership roles, where supported by the role facts Mentorship and professional development opportunities within a clinical or regulatory organization Exposure to high-stakes regulatory processes and complex clinical data Flexibility in work arrangements, where offered by the client organization Potential involvement in bringing innovative therapies from development through regulatory approval About Specialist Staffing Group Specialist Staffing Group works with leading organizations across life sciences, healthcare, and clinical research to connect talented professionals with meaningful roles in therapeutic development, regulatory compliance, and patient safety. We partner with organizations advancing innovation in clinical trials, medical devices, pharmaceuticals, and healthcare services. 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.