We are seeking a Senior Medical Writer to join our team on a contract basis. This role focuses on developing high-quality clinical and regulatory documentation that supports the advancement of life-changing therapies. You would work with cross-functional teams to translate complex scientific data into clear, compliant communications that meet regulatory standards and serve patient safety. 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 Senior Medical Writer roles within clinical development and regulatory affairs. Roles of this type support the preparation of regulatory submissions, clinical trial protocols, and safety documentation for life sciences organizations advancing innovative treatments. The work could involve partnering with medical, clinical, quality and regulatory teams to ensure data integrity, regulatory compliance, and alignment with healthcare standards including FDA requirements and ICH guidelines. Typical role overview

Location:

New York, New York, USA Type:

Contract

•

Full-time Rate:

$560 - $800 per day

Domain:

Clinical development

• Regulatory affairs

• Life sciences What you would do Typical responsibilities could include: Developing and reviewing clinical trial protocols, investigator's brochures, and case report forms Preparing regulatory submissions, including INDs, BLAs, and NDAs, with attention to FDA requirements and ICH guidance Translating complex clinical and preclinical data into clear, scientifically accurate regulatory and clinical documentation Ensuring data integrity, accuracy, and compliance with healthcare regulations and company standards Collaborating with medical, clinical, quality, regulatory and cross-functional teams to align messaging and meet submission timelines Mentoring junior writers and contributing to the refinement of medical writing standards and processes Maintaining current knowledge of regulatory requirements, therapeutic areas, and industry best practices What you could bring Most roles of this type require the following: Must-have 10-15 years of medical writing experience, including minimum 5+ years leading or mentoring writing teams Demonstrated expertise in clinical trial protocols, regulatory submissions, and safety documentation Strong working knowledge of FDA regulations, ICH guidelines, GCP, and healthcare compliance standards Advanced degree in Life Sciences, Biology, Pharmacy, or related field Excellent scientific writing, data interpretation, and communication skills Experience with clinical data and regulatory submission formats Authorization to work in the United States Nice-to-have Professional medical writing certification or

EMWA/AMWA

membership Experience with therapeutic areas such as oncology, cardiovascular, or rare diseases Familiarity with electronic submission formats and regulatory tracking systems Master's degree or PhD in a life sciences discipline 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 shape regulatory and clinical communications for innovative therapies that could impact patient outcomes Scope to lead and mentor medical writing teams, driving quality and compliance standards Potential for progression toward principal-level responsibility, where supported by role scope Exposure to cross-functional regulatory, clinical, and commercial strategy Flexibility and professional development opportunities, including ongoing training in emerging therapeutic areas and regulatory frameworks Engagement with high-stakes submissions and the satisfaction of supporting healthcare innovation About Specialist Staffing Group We partner with leading life sciences, clinical development and healthcare organizations to connect experienced professionals with impactful opportunities. Our focus is on identifying talented medical writers, regulatory specialists, and clinical professionals who bring expertise, integrity, and a commitment to patient safety and data accuracy. 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.