Medical Writer

Job Description

Medical Writer

The Medical Writer for the Sleep & Respiratory Care business 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), and heavily contribute to Periodic Safety Update Reports (PSURs).

Your role:

• Ensures strict compliance with Good Documentation Practices and regulatory standards for all clinical evaluation documents.
• Develop and update clinical evaluation deliverables, including CEPs, CERs, and PMCFP/Rs, in accordance with MEDDEV 2.7.1 Rev. 4 and EU MDR requirements.
• Collects, analyzes, and synthesizes data from various sources to assess medical device safety and performance, identifying evidence gaps and supporting strategic decisions.
• Collaborates cross-functionally to produce accurate, compliant documents and leads process improvements for greater efficiency and quality.
• Coordinates review meetings, manages deliverable timelines, and facilitates responses to regulatory inquiries to support successful submissions and approvals.

You're the right fit if:

• You’ve acquired 2+ years of experience with medical writing in the medical device industry with a bachelors degree or higher OR some experience with an advanced degree or higher. Clinical research or healthcare experience preferred; knowledge of sleep and respiratory care therapies preferred. Experience with and knowledge of Embase, PubMed, as well as Distiller and Zotero is preferred.
• Your skills include strong knowledge of relevant regulatory requirements, standards, and guidance’s (EU 2017/745, MEDDEV 2.7.1 Rev 4, ISO 13485, ISO 14155, ISO 14971, applicable MDCGs). Comfortability working within GDP and familiarity with relevant writing styles (e.g., AMA) and good publication practices (e.g., ICMJE).
• You have an advanced degree (MS, MA, MPH, PharmD, PhD, MD) strongly preferred; bachelor’s degree in a scientific field required.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You have a demonstrated ability to work in a team environment, including leading discussions and presenting to internal business and regulatory stakeholders. You are able to multi-task and manage multiple projects with ability to adapt as needed.

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.

This is a field-based role.

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.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in AZ, AR, ID, IA, KS, KY, LA, ME, MS, MO, MT, NE, NM, OK, SC, SD, TN, UT, and WV are $96,188 to $153,900.

The pay range for this position in AL, CO, FL, GA, IL, IN, MI, MN, NV, NH, NC, ND, OH, OR, PA, TX, VT, VA, WI, and WY are $101,250 to $162,000.

The pay range for this position in AK, DE, HI, MD, RI, and WA is $106,313 to $170,100.

The pay range for this position in CA, CT, MA, NJ, NY, DC, is $113,400 to $181,440.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

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.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.