Clinical Technical Writer
ZOLL Medical Corporation
At ZOLL, we're passionate about improving patient outcomes and helping save lives.
We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Resuscitation division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won’t just have a job. You’ll have a career—and a purpose.
Join our team. It’s a great time to be a part of ZOLL!
This position requires a strong candidate with experience in medical writing of clinical and regulatory documents. The position will mainly focus on development of Clinical Evaluation Plans/Reports (CERs), with future additional responsibility for development of other clinical evidence documents as part of the Medical Device Regulation (MDR) and Medical Device Directive (MDD).
- Authoring Clinical documentation mainly the Clinical Evaluation Plans and Reports (CEP/CER) including clinical section of regulatory authority requests.
- Acquire or possess in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
- Participates in and/or performs comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends.
- Providing product guidance and expertise to conduct literature searches on products/product families.
- Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment.
- Critically appraise scientific literature and write clinical summaries for products
- Managing regulatory/clinical documentation timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
- Will support broader Clinical/Scientific Affairs activities such as Regulatory submissions/responses
- Interacting with internal teams (engineering/product development/regulatory) to define the plan and strategy for development of the Clinical evaluation plans/reports for new products requiring CE Mark.
- Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
- Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
- Provide clinical perspective and support to guide new product development for CE Mark purposes. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input.
- May author routine Clinical Study Progress Reports.
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Required/Preferred Education and Experience
- Bachelor's Degree In scientific, clinical or regulatory field is preferred o equivalent work experience required.
- Must have a minimum of 2-5 years of medical writing experience.
- Minimum of 2 years of experience in clinical evaluation report writing in a medical device industry.
Knowledge, Skills and Abilities
- Previous experience in the application of in-depth therapeutic and/or device knowledge to development of clinical evaluation plans/reports.
- Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development.
- Strong experience in conducting literature searches, reviews and appraisal of the scientific data.
- Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills.
- Excellent critical and analytical thinking skills.
- Must have high level of attention to detail and accuracy.
- Must be able to work effectively on cross-functional teams.
- Must be able to manage multiple projects across numerous surgical disciplines.
- Strong communication, presentation and interpersonal skills with high attention to detail and organization.
- Strong experience in protocol development, writing clinical section for regulatory submission and clinical evaluation report writing.
- Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)
- Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.