Job Description
Are you a master of medical narrative? Apex Clinical Research is looking for a dynamic and detail-oriented Senior Medical Writer to join our elite team in New York City. In this pivotal role, you will translate complex clinical data into compelling, accurate, and accessible content for regulatory submissions, peer-reviewed publications, and marketing materials.
Our mission is to accelerate the pace of medical breakthroughs, and we need a storyteller who understands the science behind the story. You will work closely with Principal Investigators and regulatory experts to ensure our voice is authoritative, clear, and impactful.
Why Join Us?
• Competitive salary and comprehensive benefits package.
• Hybrid work model offering flexibility and collaboration.
• Professional development opportunities with industry leaders.
Responsibilities
- Lead the end-to-end writing process for clinical study reports (CSRs), protocols, and regulatory submissions (INDs, NDAs).
- Collaborate with cross-functional teams including medical directors, data managers, and regulatory affairs to ensure scientific accuracy.
- Develop high-quality manuscripts, abstracts, and posters for peer-reviewed medical journals.
- Conduct thorough literature reviews and scientific research to support manuscript development.
- Mentor junior writers and provide editorial guidance to maintain high writing standards.
- Adhere to Good Clinical Practice (GCP) guidelines and regulatory agency requirements.
Qualifications
- Master’s degree in Medicine, Life Sciences, Pharmacy, or a related field (MD, PhD, PharmD preferred).
- 5+ years of professional experience in medical writing, specifically within the pharmaceutical or biotechnology industry.
- Proven track record of authoring high-impact publications in peer-reviewed journals.
- Proficiency in industry-standard writing tools (e.g., MS Word, Adobe Acrobat Pro, EndNote, LaTeX).
- Strong knowledge of regulatory agencies (FDA, EMA) and submission processes.
- Excellent attention to detail and the ability to manage multiple deadlines in a fast-paced environment.