Remote Fda Scientist Jobs in Ohio (NOW HIRING)

We are a team of nearly 48,000 mission-driven partners striving each day to advance healthcare and improve lives. Headquartered in Dublin, Ohio, Cardinal Health, is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities

We are a crucial link between the clinical and operational sides of care, working with more than 4,500 sourcing and manufacturing partners to deliver end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

With more than 50 years in business, operations in 30 countries and approximately 46,500 employees globally, Cardinal Health is Essential to Care.

What Regulatory Sciences contributes to Cardinal Health

For over 40 years, our Regulatory Sciences team has provided strategic regulatory and scientific consulting services to pharmaceutical, biotechnology, and medical device companies worldwide. We support clients throughout the full product lifecycle, helping them navigate regulatory requirements, reduce development risks, and bring products to market successfully.

At Cardinal Health Specialty Solutions, our Medical Writers transform complex scientific and clinical data into clear, accurate, and high-quality documentation that meets regulatory requirements and client expectations . We author all types of regulatory and nonregulatory documents, including eCTD summary documents, clinical study reports, patient narratives, clinical study protocols, manuscripts, Investigator Brochures, and briefing books, among others. We are currently looking for Medical Writers in Ireland.

Key Responsibilities

• 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).
• Contribute to the planning of data analyses and presentation for CSRs; review statistical analysis plans and related documents.
• Work together with the in-house Documentation Specialist(s) to produce high-quality final documents and ensure timely delivery
• Ensure all documents meet regulatory requirements, internal quality standards, and project timelines
• Incorporate reviewer feedback and manage version control across multiple stakeholders.

Qualifications

• A Bachelor's, Master's, or PhD in life science (e.g., biology, pharmacology, or biochemistry).
• 3-5 years of regulatory/medical writing experience in the pharmaceutical industry across several therapeutics areas.
• Well-developed and proven medical writing skills.
• Must be able to translate complex medical information into clear, accurate content tailored to different audiences.
• Knowledge of regulatory document requirements and guidelines specific to ICH, FDA, and the EMA.
• The ability to work independently and as part of a team as well as under pressure meeting challenging deadlines
• Excellent interpersonal skills
• English proficiency required for this role
• Proficiency in document management tools (e.g., Veeva, MS Office)

#LI-Remote

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.

To read and review this privacy notice click here