Senior Medical Writer

Job Title

Senior Medical Writer

Job Description

As the Senior Medical Writer, you will be responsible for authoring technical documents that support the US, European Union (EU) and other international regulatory submissions of Philips Ambulatory Monitoring and Diagnostics (AM&D) division. You will also mentor junior medical writers and collaborate with AM&D Medical Affairs in writing scientific communication documents such as manuscripts, abstracts, and podium presentations.

Your role:

• Author Clinical Investigation Plan (CIP) for all upcoming AM&D clinical trials

• Author Premarket Application (PMA), 510k Premarket Submission, Clinical Study Report (CSR), Annual Progress Report (APR)

• Author Clinical Evaluation documents for existing and new products and maintain/update existing company Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) Plans and PMCF Reports according to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR

You're the right fit if:

• You have an MS Degree in scientific or medical discipline with at least 6 years of experience in the medical device industry focusing on clinical evaluation report writing or scientific writing and/or PhD, MD, PharmD, or equivalent with at least 4 years of related experience

• In depth experience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.), critically assess findings and research methodology experience (including clinical investigation design and biostatistics)

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

• 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

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.

• Read more about our employee benefits.

If you're 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 here.

Philips Transparency Details

The pay range for this position is $106,000 to $180,000, annually. The actual base pay offered may vary 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.

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.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to San Diego, CA.

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

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/Disabled/Veteran and maintains a drug-free workplace.