If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
The Medical Writer 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). In addition, the Medical Writer may contribute toward or author other technical documents that support clinical and regulatory efforts of the company.
You are responsible for
- 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.
- Develop and maintain compliant PMCF studies according to requirements of MEDDEV 2.12/2 rev. 2 and EU MDR clinical evidence needs
- Evaluate 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
- Analyze post-market surveillance data and risk management data to ensure consistency and alignment in CER and PMCFR
- Perform gap assessments of clinical documents for devices to ensure clinical documentation meets all regulatory requirements
- Contribute toward post-market surveillance and risk management programs as requested
- Remain current with regulatory requirements as they relate to clinical evaluations and clinical contributions to regulatory documents.
- Maintain thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources
- Manage timelines and communication to ensure deliverables and milestones are met.
- Prepare for and participate in audits as needed.
- Interact with internal and international teams (engineering/marketing/regulatory) to gather information and ensure compliance of the clinical evaluation for new products requiring CE Mark.
- Acquire or possess in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
- 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).
- Other duties as assigned
You are a part of
As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear collaboration with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
- Minimum of Bachelor’s 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’s or PhD) preferred with at least 2 years of related experience
- Knowledge and experience with Medical Devices Directive 93 / 42 /EEC
- Knowledge and experience with MEDDEV 2.7.1 Rev 4 Clinical Evaluations
- Knowledge and experience with MEDDEV 2.12-2 PMCF
- Experience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.)
- Knowledge of research methodology (including clinical investigation design and biostatistics) preferred
- Excellent written and oral communications skills-- strong attention to detail related to consistency, grammar, syntax, and accuracy
- Demonstrated ability to work in a team environment, including leading discussions and presenting to internal business and regulatory stakeholders
- Ability to identify and mitigate or escalate risks; identify roles/individuals to involve for decision making within clinical evaluation assessment and report development
- Project/timeline management skills and organizational skills
- Ability to prioritize and manage multiple projects and adapt to change as needed
- Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures; ability to work independently with minimal supervision
- Strong familiarity with Microsoft Office
- Research or healthcare experience preferred
- Knowledge and experience with EN ISO 14155 Clinical Investigations is a plus
- Knowledge and experience with ISO14971 Risk Management is a plus
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.