Science Director/Principal Medical Writer

Quest Diagnostics•Secaucus, NJ

About The Position

The Principal Medical Writer will leverage their clinical expertise and thought leadership to develop high-quality scientific content across a wide range of clinical topics. This role involves authoring and reviewing medical documents, collaborating with internal teams and external stakeholders, and ensuring that all communications are accurate, clear, and compliant with regulatory standards.

Requirements

Ph.D. required
Minimum of 10 years of medical writing within the life sciences industry, with a specialty in editing/writing content for peer-reviewed publication
Experience through an academic appointment or similar role, fostering interdisciplinary collaborations across diverse research teams, institutions, and industry partners.
Proven experience in medical writing, with a portfolio of published scientific manuscripts and regulatory documents as primary author or senior author/principal investigator.
Must provide proof of the most recent and important publications within the past 2-5 years.
Recognized as a Key Opinion Leader, with a track record of speaking engagements, advisory board participation, or other leadership roles.
Exceptional written and verbal communication skills, with the ability to convey complex scientific information to diverse audiences.
Strong analytical and critical thinking abilities, with keen attention to detail.
Proficiency in literature search methodologies and data interpretation.
Familiarity with regulatory requirements and guidelines for medical writing.
Ability to manage multiple projects simultaneously and meet tight deadlines.

Responsibilities

Content Development: Author and edit peer-reviewed scientific publications, including manuscripts, abstracts, posters, and presentations, ensuring clarity, accuracy, and adherence to journal or conference guidelines.
Develop regulatory documents such as clinical study reports, investigator brochures, and sections of regulatory submissions, ensuring compliance with governing bodies.
Collaboration and Stakeholder Engagement: Lead team of content contributors, including researchers, clinicians, and subject matter experts, to gather data for manuscript development.
Collaborate with internal teams, including clinical development, Analytics, regulatory affairs, and medical affairs, to gather necessary information and ensure alignment of messaging.
Engage with external stakeholders, including other KOLs, investigators, and healthcare professionals, to gather insights and incorporate feedback into medical communications.
Provide medical and scientific expertise to support publication planning and execution, ensuring alignment with overall product strategy.
Conduct literature reviews and provide context to internal stakeholders for future research and development.
Offer insights into clinical development plans, study designs, and data interpretation based on clinical experience and current medical knowledge.
Ensure all written materials are of high quality, scientifically accurate, and comply with applicable guidelines and regulations.
Implement quality control processes to maintain consistency and accuracy across all documents.