Regulatory Medical writers play a critical role in translating complex clinical and scientific data into clear, compliant documentation that supports product development and regulatory submissions. This opportunity could focus on drafting, reviewing and maintaining regulatory documents for clinical trials and product submissions. 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 Regulatory Medical Writer positions, roles that could support the advancement of clinical programs and ensure regulatory compliance across healthcare initiatives. Roles of this type typically sit within a dynamic clinical development environment where precision, attention to detail and regulatory knowledge are essential. The work could involve collaborating with cross-functional teams including clinical, quality, regulatory and operations to produce accurate, compliant documentation that meets FDA, ICH and other regulatory standards. Typical role overview

Location:

Boston, Massachusetts, USA Type:

Contract

•

Full-time Rate:

$400 - $480 per day

Domain:

Clinical development

• Regulatory documentation What you would do Typical responsibilities could include: Drafting and editing regulatory documents including clinical trial protocols, study reports, and regulatory submissions Ensuring all documentation meets FDA, ICH and other applicable regulatory guidelines Collaborating with clinical, quality and regulatory teams to maintain data integrity and accuracy Reviewing clinical data and translating findings into clear, compliant written formats Managing document revisions and maintaining version control Supporting regulatory submissions and audit readiness activities Ensuring patient safety and compliance are maintained across all written materials What you could bring Most roles of this type require the following: Must-have 2 to 5 years of experience in medical writing, regulatory documentation, or clinical development Bachelor's degree in Life Sciences, Biology, Pharmacy or a related field Strong knowledge of FDA regulations, ICH guidelines and GCP standards Proficiency in clinical trial protocol development and regulatory document preparation Excellent written and verbal communication skills Ability to work independently and manage multiple projects simultaneously Authorization to work in the United States Nice-to-have Master's degree in relevant field or related certifications Experience with regulatory submissions in multiple therapeutic areas Familiarity with electronic data capture systems and regulatory software 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 contribute to the development of therapeutics that improve patient outcomes Exposure to regulated clinical development processes and regulatory strategy Potential for professional growth and skill development in medical writing Collaborative work environment with experienced clinical and regulatory professionals Flexible contract arrangement with potential for extension based on project needs Remote work flexibility where applicable About Specialist Staffing Group We are a specialized recruitment firm dedicated to connecting talented healthcare and life sciences professionals with meaningful contract and permanent opportunities. Our mission is to support the advancement of clinical programs and healthcare innovation by matching skilled professionals with organizations that value expertise, compliance and patient safety. 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.