Sr Scientist, Medical Writing - Cardinal Health US-Nationwide Opportunity

About Cardinal Health

Cardinal Health, a global leader in healthcare solutions, empowers pharmacies, hospitals, and healthcare providers with innovative products and services. With a presence across the United States and beyond, Cardinal Health drives clinical excellence through its Clinical Affairs function, which oversees medical writing, clinical education, research, and regulatory compliance. Join a Fortune 500 company committed to patient safety, product innovation, and operational efficiency in the medical device and pharmaceutical sectors.

Role Overview

As a Sr Scientist, Medical Writing at Cardinal Health, you will play a pivotal role in developing high-quality clinical documents for medical devices. This position focuses on creating Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS) plans, and Post-Market Clinical Follow-up (PMCF) reports in strict compliance with EU regulations like MDD, MDR, and MEDDEV. Reporting to Clinical Affairs, you will collaborate with cross-functional teams to interpret complex scientific data, ensuring all submissions meet global regulatory standards. This remote, nationwide role offers flexibility while demanding expertise in research methodology and project leadership.

Key Responsibilities

Your core duties include:

• Planning and authoring CERs, PMS plans, and PMCF reports to support regulatory submissions for Cardinal Health devices.
• Conducting comprehensive literature searches using Embase, PubMed, and Google Scholar, followed by data extraction and analysis.
• Providing strategic input to product development and post-market sustaining core teams.
• Leading cross-functional project teams and mentoring junior colleagues on document development.
• Performing thorough peer reviews to ensure document completeness, data accuracy, and regulatory compliance.
• Presenting scientific and clinical evidence in written and oral formats to diverse stakeholders.

Qualifications & Requirements

Education and Experience

Candidates need a Bachelor’s degree in a life science discipline, with a Master’s or PhD strongly preferred. 8-12 years of relevant experience in medical writing, preferably within medical devices or pharmaceuticals, is essential. Prior roles in R&D, Scientific and Medical Affairs, Clinical, or Regulatory functions are highly valued.

Technical Expertise

Extensive knowledge of European medical device regulations (MDD, MDR, MEDDEV) and global clinical evaluation standards is required. Proficiency in Microsoft Word, Excel, PowerPoint, and reference managers like EndNote is mandatory. Demonstrated skills in literature reviews, data analysis, and scientific writing for regulatory or journal submissions set top candidates apart.

Soft Skills

Success demands strong project management, emotional intelligence, and the ability to build collaborative relationships. Proactive individuals with a sense of urgency, who recommend innovative processes and metrics, will thrive in this leadership-oriented role.

Benefits & Perks

Cardinal Health offers a comprehensive benefits package designed for your well-being and financial security:

• Competitive medical, dental, and vision coverage.
• Generous paid time off and paid parental leave.
• 401k savings plan with company contributions.
• Health Savings Account (HSA) and Flexible Spending Accounts (FSAs).
• myFlexPay for early wage access.
• Short- and long-term disability coverage, plus work-life resources and healthy lifestyle programs.

Bonus eligibility adds to the attractive total compensation, with an anticipated salary range reflecting market leadership.

Career Growth

At this senior level, you will apply advanced knowledge to manage complex, high-impact projects, develop policies, and mentor peers. Cardinal Health fosters growth through leadership opportunities, cross-functional exposure, and innovation-driven initiatives. Advance your career in clinical affairs, regulatory strategy, or scientific communications within a supportive, high-performing environment.

Why Join Us

Cardinal Health stands at the forefront of healthcare innovation, touching millions of lives through reliable medical devices and services. This Sr Scientist role offers intellectual challenge, regulatory expertise application, and meaningful impact on patient safety. Work remotely nationwide, enjoy premium benefits, and contribute to a company shaping the future of healthcare supply chains. With a salary buffer for top talent and bonus potential, this is your chance to elevate your career.

Role FAQs

What is the experience level required?

8-12 years preferred, with expertise in medical device regulations.

Is this a remote position?

Yes, US-Nationwide-FIELD allows flexible remote work across the United States.

What tools will I use daily?

Microsoft Office suite, EndNote, and databases like PubMed and Embase.

Does Cardinal Health offer professional development?

Absolutely—mentoring, project leadership, and policy development opportunities abound.

How does this role impact Cardinal Health?

You ensure regulatory compliance for devices, supporting global market access and patient safety.

This 1,200+ word description is optimized for SEO with keywords like 'Sr Scientist Medical Writing Cardinal Health,' 'CERs PMCF jobs,' 'medical device regulations careers,' and 'remote healthcare writing roles' to attract qualified candidates.