Job Description

Job Title Senior Medical Writer



Senior Medical Writer

You will primarily focus on and be responsible for authoring and maintaining Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up Plans (PMCFPs) and Post-Market Clinical Follow-up Reports (PMCFRs) but also have the opportunity to contribute toward or author other technical documents that support clinical and regulatory efforts of the company as well as mentor more junior medical writers and support internal team revisions and reviews.

Your role:

• Author Clinical Evaluation documents for new products and maintain/update existing company CEPs, CERs, and PMCFP/Rs according to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR.
• Evaluate and analyze clinical evidence from clinical investigations, published literature, post-market surveillance, risk assessments and post-market clinical data, and be able to generate a report of these data and draw supported conclusions regarding support for device safety, performance, and conformity to relevant GSPRs.
• Perform gap assessments of clinical documents for devices to ensure clinical documentation meets all regulatory requirements.
• Maintain thorough knowledge of assigned products.
• Identify appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources and manage timelines and communication to ensure deliverables and milestones are met.
• Comply with Good Documentation Practices to ensure quality and accuracy of document content and format, ensure compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines) and you are also expected to mentor junior writers

You\'re the right fit if:

• Minimum of Bachelor\xe2\x80\x99s Degree in scientific or medical discipline with at least 5 years of experience in clinical evaluation report writing in the medical device industry or in scientific writing; an advanced degree (Master\xe2\x80\x99s, PhD, MD, PharmD, or equivalent) preferred with at least 2 years of related experience
• You possess and demonstrate knowledge of European Union (EU) Medical Device Regulations (MDR), Medical Devices Directive 93/42/EEC, MEDDEV 2.7.1 Rev 4 Clinical Evaluations and MEDDEV 2.12-2 PMCF
• Experience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.) as well as research methodology experience (including clinical investigation design and biostatistics) preferred.
• Excellent written and oral communications skills-- strong attention to detail related to consistency, grammar, syntax, and accuracy, strong skills working in a team environment, including leading discussions and presenting to internal business and regulatory stakeholders.
• Knowledge and experience with EN ISO 14155 Clinical Investigations and ISO14971 Risk Management is a plus.
• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

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About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won\'t stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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If you\xe2\x80\x99re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

Additional Information

All United States-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation. *Montana employees, learn more .

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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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