Philips is hiring: Senior Medical Writer in Shawnee

Philips Senior Medical Writer in Lenexa, Kansas

Senior Medical Writer - Sleep & Respiratory Care

The Senior Medical Writer will be responsible for authoring and maintaining clinical and post-market documentation (CEPs, CERs, PMCFPs, and PMCFRs). This person may also contribute to authoring other technical documents that support Clinical, Regulatory, Risk Management, or Post-Market Surveillance efforts (e.g., Clinical Evidence Strategies, Benefit-Risk Determinations, PSURs).

Your role:

1. Contributing to and authoring clinical evaluation deliverables for new and sustaining products (CEPs, CERs, and PMCFP/Rs) according to MEDDEV 2.7.1, Rev. 4 and compliant with EU MDR.
2. Compiling, appraising/analyzing, and synthesizing multiple types and sources of data (e.g., clinical study results, post-market surveillance data, risk assessments, published literature) to evaluate product safety and performance and identify potential evidence gaps.
3. Acquiring/maintaining thorough knowledge of business unit products, competitor devices, current clinical/market developments, and literature review processes.
4. Interacting with cross-functional teams to ensure compliance of the clinical evaluation for new products requiring CE Mark and ensuring compliance with internal policies and procedures.
5. Managing timelines and communication to ensure deliverables and milestones are met; complying with Good Documentation Practices to ensure quality and accuracy of document content and format; and preparing for and participating in audits, as needed.

You're the right fit if:

1. You have experience in clinical research or healthcare experience strongly preferred; knowledge of sleep and respiratory care therapies preferred.
2. You possess strong experience and skill in performing systematic searches of the medical/scientific literature using tools including Embase and PubMed, and are highly skilled with data extraction and related tools (e.g., Distiller, Zotero).
3. You have advanced knowledge and experience with international regulatory requirements, standards, and guidance (EU 2017/745, MEDDEV 2.7.1 Rev 4, ISO 13485, ISO 14155, ISO 14971, applicable MDCGs).
4. You have a minimum of BS/BA in a scientific or medical discipline with at least 7 years of experience in clinical evaluation report writing in the medical device industry OR an advanced degree (MS, MA, MPH, PharmD, PhD, MD) strongly preferred with at least 2 years of direct experience in clinical evaluation report writing in the medical device industry.
5. You have excellent written English and oral communication skills with strong attention to detail related to consistency, grammar, syntax, and accuracy.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

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.

Additional Information

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.

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

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