Medical - Clinical Writing Team Lead

We currently have a career opening for a Medical - Clinical Writing Team Lead.

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.

Qualifications

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).

Benefits

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with myFlexPay

Flexible spending accounts (FSAs)

Short- and long-term disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Anticipated salary range: $123,400 - $158,670.

Bonus eligible: Yes.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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