Sr. Medical Writer (Creative Design)

CooperVision, a division of CooperCompanies (NYSE: COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com 

Job Summary:

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. 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.
• Previewing 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%.

Qualifications

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.
• Able to work effectively in multinational/multicultural environments.
• Professionally conducts self with coworkers, management, customers, and others. Model the corporate values.
• 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

Work Environment:

• Professional Office setting, willing to report to Pleasanton, CA location.
• Sedentary to light physical effort necessary to perform the job. 

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.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $103,583 and $138,110 and may include cost of living adjustments.  The actual base pay includes many factors and is subject to change and modification in the future.  This position may also be eligible for other types of compensation and benefits.

Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran

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