Medical Writer

Job Title

Job Description

Medical Writer Hospital Patient Monitoring (EST time zone)

You will be responsible for helping with authoring and maintaining clinical and post-market documentation such as CEPs CERs PMCFPs and PMCFRs and contribute to our 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:

• Enforces rigorous adherence to Good Documentation Practices meticulously maintaining the quality and accuracy of document content and format to meet stringent regulatory standards and internal protocols working under direct supervision.
• Handles the development of clinical evaluation deliverables for new products and meticulously updates existing company CEPs CERs and PMCFP/Rs in strict accordance with MEDDEV 2.7.1 Rev. 4 guidelines and compliant with EU MDR regulations.
• Compiles and synthesizes a wide array of data types and sourcesincluding clinical study results post-market surveillance data risk assessments and published literatureto conduct comprehensive evaluations of medical device safety and performance identifying potential evidence gaps and informing strategic decision-making.
• Collaborates with the team to generate accurate and compliant documents by applying standard software tools and internal procedures ensuring adherence to external standards regulations and guidelines. Engages with peers regularly to share knowledge experiences and best practices fostering a collaborative environment for collective learning and professional development.
• Analyzes complex issues and identifies opportunities to improve or adapt existing methods and processes to enhance efficiency and quality in document preparation and submission.

Youre the right fit if:

• Youve acquired some experience in scientific writing (publications white papers brochure writing etc.) required; medical writing experience in the medical device industry strongly preferred.
• Your skills include high comfortability and experience working within GDP and knowledge of relevant writing styles (e.g. AMA) and good publication practices (e.g. ICMJE); Strong knowledge of clinical research methodology including study design outcomes and measures and biostatistics is preferred; strong ability to identify mitigate and escalate risks and strong ability to meet prioritize and meet multiple project deadlines. You have excellent written English and oral communications skills with strong attention to detail related to consistency grammar syntax and accuracy. Advanced microsoft office formatting and data analysis skillsets required (pivot tables table formatting in word etc.)
• You have a PhD/MD/PharmD in a scientific or medical discipline required.
• You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.
• Youre a self-starter with an ability to learn quickly and self-educate on different medical device products and procedures; have strong project/timelines management skills and organizational skills as well as a demonstrated to work and communicate effectively in a team environment including leading discussions and presenting to internal business and regulatory stakeholders.

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 companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.

This is a field-based role with a strong preference to hire someone in EST time zone.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters and we wont 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 $71250 to $114000.

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 $75000 to $120000.

The pay range for this position in AK DE HI MD RI and WA is $78750 to $126000.

The pay range for this position in CA CT MA NJ NY DC is $84000 to $134400.

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.

Company relocation benefits will not be provided for this position.

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.