Clinical Writer

ZOLL Medical Corporation - Minnetonka, MN

Full-time - Mid Level

Minnetonka, MN

10,001+ employees

Merchant Wholesalers, Durable Goods

About the position

At ZOLL, we are dedicated to improving patient outcomes and saving lives through innovative technologies. Our Acute Care Technology division develops and delivers lifesaving products and software solutions to EMS, hospitals, public safety, and military customers globally. We are currently seeking a strong candidate for a medical writing position focused on the development of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER). This role will also involve the creation of other clinical evidence documents in compliance with the Medical Device Regulation (MDR) and Medical Device Directive (MDD). The successful candidate will be responsible for authoring clinical documentation, particularly the Clinical Evaluation Plans and Reports, and will need to acquire in-depth knowledge of therapeutic areas, competitor devices, and current clinical developments. This includes conducting comprehensive literature searches to support product lines and clinical studies, as well as summarizing risks and benefits from the literature. The role requires managing regulatory and clinical documentation timelines, supporting broader Clinical/Scientific Affairs activities, and interacting with internal teams to define strategies for new product development requiring CE Mark. Additionally, the candidate will conduct proofreading, editing, and document formatting, ensuring compliance with corporate and regulatory requirements. The position demands strong communication skills, attention to detail, and the ability to manage multiple projects across various surgical disciplines. ZOLL is a fast-growing company with a commitment to making a difference in patients' lives, and we value innovation and self-motivation in our employees. Join us in our mission to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions.

Responsibilities

• Author Clinical Evaluation Plans and Reports (CEP/CER) including the clinical section of regulatory authority requests.
• Conduct comprehensive literature searches to maintain in-depth knowledge of current scientific literature.
• Review literature to interpret and summarize risks, alternate therapies, and device-specific benefits.
• Manage regulatory/clinical documentation timelines required by product development teams and global Regulatory Bodies.
• Support broader Clinical/Scientific Affairs activities such as regulatory submissions/responses.
• Interact with internal teams to define the plan and strategy for development of Clinical evaluation plans/reports for new products requiring CE Mark.
• Conduct proofreading, editing, document formatting, and review comment integration.
• Perform periodic reviews of risk documentation and product labeling to ensure appropriate updates are implemented.
• Provide clinical perspective and support to guide new product development for CE Mark purposes.
• Author routine Clinical Study Progress Reports.

Requirements

• Bachelor's Degree in scientific, clinical or regulatory field is preferred or equivalent work experience.
• Minimum of 2-5 years of medical writing experience required.
• Minimum of 2 years of experience in clinical evaluation report writing in a medical device industry is preferred.
• Previous experience in the application of in-depth therapeutic and/or device knowledge to development of clinical evaluation plans/reports.
• Strong experience in conducting literature searches, reviews, and appraisal of scientific data.
• Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing.
• Excellent critical and analytical thinking skills.
• High level of attention to detail and accuracy.
• Ability to work effectively on cross-functional teams.
• Strong communication, presentation, and interpersonal skills.

Nice-to-haves

• Experience in protocol development and writing clinical sections for regulatory submissions.
• Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures.
• Demonstrated dedication or strong work ethic to meet aggressive timelines.

Benefits

• Comprehensive health insurance coverage.
• 401k retirement savings plan with matching contributions.
• Paid time off and holidays.
• Opportunities for professional development and continued education.