Regulatory Medical Writers play a vital role in translating complex clinical and scientific data into clear, compliant documentation that supports product development and patient safety. This opportunity could involve working on regulatory submissions, clinical trial protocols, and safety reports within a dynamic life sciences environment. 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 within clinical development and regulatory affairs. Roles of this type could support the preparation and maintenance of regulatory documentation that drives healthcare compliance and ensures data integrity throughout the product lifecycle. You could work within a collaborative team environment focused on clinical trial protocols, regulatory submissions, and post-market safety reporting. The work could involve partnering with clinical, quality, and regulatory teams to translate scientific evidence into clear, accurate documentation under FDA, ICH and other global regulatory frameworks. Typical role overview

Location:

New York, New York, USA Type:

Contract

•

Full-time Rate:

$400 - $480 per day

Domain:

Clinical / Life Sciences

• Regulatory Affairs What you would do Typical responsibilities could include: Drafting and editing regulatory documents, including Clinical Trial Agreements (CTAs), Investigator's Brochures (IBs), and safety reports Preparing submissions and supporting documents for regulatory agencies such as the FDA Ensuring compliance with ICH guidelines, 21 CFR Part 11, and other regulatory standards Reviewing clinical trial protocols and safety data to maintain accuracy and completeness Collaborating with clinical operations, quality assurance, and regulatory teams to ensure data integrity Managing document version control and maintaining regulatory files Supporting responses to regulatory agency requests and post-market surveillance activities What you could bring Most roles of this type require the following: Must-have 2-5 years of experience as a Medical Writer, Regulatory Medical Writer, or Clinical Writer Bachelor's degree in Life Sciences, Biology, Pharmacy, or related field Strong knowledge of FDA regulations, ICH guidelines, and regulatory submission processes Demonstrated experience with clinical trial documentation and safety reporting Excellent written and verbal communication skills Attention to detail and commitment to data integrity and patient safety Authorization to work in the United States Nice-to-have Advanced degree (Master's or PhD) in a life sciences discipline Industry certifications such as AMWA or EMWA membership Experience with regulatory information management systems (RIMS) Familiarity with electronic data capture (EDC) systems What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: Exposure to the full lifecycle of clinical development and regulatory processes Opportunity to contribute directly to bringing safe, effective healthcare solutions to patients Collaborative work environment with experienced clinical and regulatory professionals Professional development through exposure to diverse therapeutic areas and regulatory pathways Flexible work arrangements where supported by the role and organizational needs Contract-based engagement with competitive daily rates reflecting market standards and experience About Specialist Staffing Group Specialist Staffing Group partners with leading organizations across life sciences, healthcare, and clinical research to connect talented professionals with meaningful opportunities. We focus on building long-term relationships with both candidates and employers, ensuring the right fit for contract, permanent, and project-based roles. Our network spans regulatory affairs, clinical operations, medical writing, quality assurance, and related disciplines. 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.