This is an opportunity to register your interest in future Principal Medical Writer positions within clinical development and regulatory affairs. These senior-level roles could support the advancement of therapeutics through strategic medical communication, regulatory strategy, and clinical evidence synthesis for healthcare organizations and life sciences companies. Please note the content of this advert does not represent a live vacancy. About the opportunity Roles of this type may sit within dynamic clinical research, regulatory affairs, or medical communications functions where senior medical writers lead evidence strategy, mentor junior teams, and shape how clinical data is communicated to regulatory bodies, healthcare providers, and patients. The work could involve owning complex regulatory submissions, designing clinical trial protocols, directing medical communication strategy, and ensuring data integrity and patient safety across therapeutic programs. Typical role overview

Location:

New York, New York, USA — permanent, full-time

Salary:

$130,000 - $190,000 per annum, dependent on experience

Experience:

10-15 years in medical writing, clinical research, or regulatory affairs, with 5+ years leading teams

Domain:

Clinical development

• Regulatory affairs

• Medical communications What you would do Typical responsibilities could include: Leading the development and submission of regulatory documents, including clinical study reports, common technical documents (CTDs), and regulatory correspondence Directing medical writing strategy and clinical evidence synthesis for therapeutic programs from preclinical through post-market phases Owning the design and documentation of clinical trial protocols, informed consent forms (ICFs), and safety reports in compliance with GCP and regulatory requirements Mentoring and leading a team of medical writers and junior staff, setting standards for quality, consistency, and compliance Ensuring data integrity, accuracy, and patient safety across all written deliverables Partnering with clinical, regulatory, and cross-functional stakeholders to translate complex clinical data into clear, compelling narratives Managing timelines and regulatory submissions to support program advancement and market access Staying current with evolving regulatory guidance, therapeutic area standards, and healthcare compliance requirements What you could bring Most roles of this type require the following: Must-have 10-15 years of professional experience in medical writing, clinical research coordination, or regulatory affairs 5+ years leading, mentoring, or managing medical writing teams or junior staff Advanced degree in Life Sciences, Pharmacy, Biology, or equivalent clinical/scientific discipline Deep expertise in regulatory document preparation, clinical trial protocol development, and GCP/ICH guidelines Demonstrated knowledge of FDA, EMA, or other regulatory pathways and submission requirements Proficiency with medical writing software, clinical trial management systems, and data integrity tools Strong project management and stakeholder communication skills across clinical, regulatory, and commercial functions Authorization to work in the United States Nice-to-have Advanced certification in medical writing (such as EMWA, AMWA, or EMWF credentials) Direct experience with oncology, rare disease, or other specialty therapeutic areas Familiarity with real-world evidence (RWE) and health economics outcomes research (HEOR) Experience supporting FDA submissions or post-market surveillance activities What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: Leadership scope to shape regulatory strategy and clinical evidence communication at a strategic level Opportunity to mentor and develop junior medical writers, building a high-performing team Potential involvement in bringing innovative therapeutics to patients through clear, compliant documentation Autonomy in managing complex regulatory programs and cross-functional stakeholder relationships Professional development and progression toward senior leadership or strategic advisory roles within clinical and regulatory functions Benefits including medical, dental, and vision coverage, paid time off, retirement planning, and flexible work arrangements where supported by the role About Specialist Staffing Group We partner with leading healthcare and life sciences organizations to find talented professionals who are passionate about advancing patient care and regulatory excellence. Our network spans clinical research, medical writing, regulatory affairs, and healthcare quality — connecting experienced professionals with opportunities to make a real impact in the industry. 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.