Senior Medical Writer

JOB TITLE – Senior Medical Writer

DEPARTMENT – Research & Development

LOCATION – Chandlers Ford

WORKING HOURS – Monday – Friday, 0830 - 1630

Do amazing things as part of your every day.

What we do every day feels pretty amazing – we help improve the way people see each day. It’s about more than making contact lenses, it’s about giving lens wearers freedom and confidence. And everybody has a part to play in making this happen – everybody’s contribution counts, whatever their role or experience. Which is why at CooperVision, you’ll feel empowered, trusted and supported in everything you do.

What will you be doing:

In this role, you will fully own clinical-related technical writing for medical device regulatory projects (CER, MDD/ MDR compliant format, literature review and analysis) and support clinical projects including study reports and manuscripts. You will also provide insights and expertise on regulatory gap closures.

Essential Functions & Accountabilities:

• Implements CER strategies and interfaces with project team members, both within the organization and with a diverse range of external groups, to drive deliverables to completion
• Develop approaches and methodologies based on established, changed and new legislation, regulation and guidance documentation. Specifically, with the existing MDD and new EU MDR requirements, including those outlined in existing and emerging EU Commission’s CER MDCG guidance
• Collect, summarize, and analyze CERs for periodic review as per regulatory guidance such as MDCG 2020-5, 2020-6, Regulation (EU) 2017/745 on Medical Devices (MDR), Council of the European Union, MEDDEV 2.7/1. Data may include scientific literature review, post-market surveillance, biological evaluation, technical documentation, and clinical investigations. Ability to identify clinical risks that may require support for product safety, liaison with Clinical and Regulatory groups, as applicable
• Stay abreast of all pertinent regulatory affairs issues, including MDCG guidance. Interprets and applies FDA regulations to business practices and provides regulatory input, advice and guidance to the organization
• Active follow-up on the progression of technical documentation activities required to successfully and timely complete the deliverables
• Periodically reviewing medical literature for new information that may warrant supplemental updates to CERs as applicable (e.g., if new risks are identified) and for reporting of device safety and performance data
• Conducting comprehensive literature searches for product/technology evaluations to support product development, risk analysis, regulatory submissions, due diligence efforts. Writing ad hoc reports based on these literature searches for internal distribution or regulatory submission
• Writing and/or editorial review (for accuracy/clarity) of core clinical study documentation for submission to regulatory agencies, for distribution to investigational centers, or intra-company use, including: study protocols, investigator brochures, risk/benefit and integrated summaries from raw data (i.e., aggregate adverse event narratives), compiling, analyzing and summarizing data for comprehensive study reports, tables, charts, figures, and other visual display elements for presenting clinical data
• Assisting members of the Clinical Affairs team in effective visual and written communication, including manuscripts and conference presentations
• As needed, project management of Clinical Research Organizations (CRO) conducting post-market follow-up (PMCF) clinical studies when CooperVision is considered the Sponsor
• Travel up to 10%

What skills and experience should you have?

Knowledge, Skills, and Abilities:

• Experience with EU MDR CEPs/CER; experience with literature analysis; experience with managing a writing project from start to end
• Cross functional understanding of Design Control and Clinical Affairs
• Working knowledge of adverse event reporting and international vigilance reporting
• Strong project management and technical writing skills
• Attention to detail, systematic and orientation toward careful meticulous work
• Effective communicator. Able to convey messages logically and concisely. Consistently reinforces regulatory/clinical expectations and requirements
• Must be proficient with MS Word Office Suite for PC, MS Excel, Adobe Acrobat XPro, MS Project, PubMed/ Embase/ Endnote
• Familiarity with Agile Project Lifecycle Management
• Working with CROs

Experience:

• Minimum 5 years’ experience in Medical Device Technical Writing
• Direct experience in creating clinical-related documents for CE submission
• Working knowledge of the EU Medical Device Directive and Medical Device Regulation

Education:

• Bachelor’s degree required in a scientific or technical discipline from an accredited year college or university
• Certifications or achievements in technical writing is desirable
• Master’s degree in regulatory, scientific, or technical discipline university, preferred
• Working knowledge of medical device regulations, with formal education in regulatory discipline preferred

What we offer

You’ll receive competitive compensation and a fantastic benefits package including; 25 days holiday, bonus, pension scheme, healthcare cover, life assurance, a discounted contact lens scheme and much more!

You’ll benefit from extensive training opportunities and personal development. Gain insights and inspiration from collaborating with teams all over the globe. You’ll be joining a friendly team that’s open, flexible and respectful of each other’s differences. We understand that different perspectives bring fresh and unique insights to the mix.

If you like what you see, take the first step towards your brighter future and apply today. All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

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