Medical - Clinical Writing Team Lead

Cardinal Health

4d•$123,400 - $158,670

About The Position

For over four decades, our industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology, and medical device companies get their products to market. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on your research investments. We provide efficient scientific and regulatory consulting services throughout the full product lifecycle to help ensure the continued success of your product post-approval. The medical writers at Cardinal Health Specialty Solutions summarize data into concise and accurate reports in formats that comply with regulatory agency requirements and client expectations. We author all types of regulatory and non‑regulatory documents, including eCTD summary documents, clinical study reports, patient narratives, clinical study protocols, manuscripts, Investigator Brochures, and briefing books, among others.

Requirements

Advanced degree in life sciences (PhD, PharmD, MD, or MS required).
Advanced regulatory/medical writing experience in the pharmaceutical industry across several therapeutics areas.
Well-developed and proven medical writing skills.
Knowledge of regulatory document requirements and guidelines specific to ICH, FDA, and the EMA
The ability to develop and mentor more junior medical writers.
The ability to work independently and as part of a team.
The ability to work under pressure and meet challenging deadlines.
Excellent interpersonal and presentation skills.
Advanced level of English proficiency required for this role.
Proficiency in document management tools (e.g., Veeva, MS Office)

Responsibilities

Acts as a Subject Matter Expert, guides strategic decisions, and oversees multiple writers.
Write, review, and/or edit clinical regulatory documents such as CTD Module 2 summaries and Clinical Overviews, Clinical study reports (CSRs), and other regulatory documents, as needed (e.g., Responses to Health Authority questions, Briefing Books, 120-day Safety updates, Pediatric Investigational Plans, or Investigator Brochures.
Contribute scientifically and strategically to submission teams at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing (e.g., provide content expertise and guidance on regulatory requirements).
Translate and summarize complex biostatistical concepts and preclinical/clinical data into clear, accurate scientific reports.
Work seamlessly with cross-functional stakeholders, including Clinical Sciences, Clinical Pharmacology, Biometry, Drug Safety, Clinical Operations, CMC, and Regulatory Affairs.
Participate in document planning meetings, timeline development, and content strategy discussions.
Oversee document timelines, ensuring projects are delivered on time and on-budget.