Senior Medical Writer

JOB DESCRIPTION

Job Title

Senior Medical Writer

Job Description

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 our author 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 :

• 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 to EU MDR. You will also contribute to Risk Management and Post-Market Surveillance function efforts, as needed.
• Responsible for 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 to identify potential evidence gaps.
• Acquire / maintain thorough knowledge of business unit products, competitor devices, state-of-the-art, current clinical / market developments, literature review processes and the ability to keep current with relevant literature. Must also remain current with regulatory requirements as they relate to clinical evaluations and contributions to regulatory documents.
• Interaction 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.
• Must manage timelines and communication to ensure deliverables and milestones are met; comply with Good Documentation Practices to ensure quality and accuracy of document content and format; and prepare for and participate in audits, as needed.

You're the right fit if :

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.

Philips Transparency Details

The pay range for this position in AZ, AR, ID, IA, KS, KY, LA, ME, MS, MO, NE, NM, OK, SC, SD, TN, UT, or WV is $122,906 to $196,650.

The pay range for this position in AL, CO, FL, GA, HI, IL, IN, MI, MN, NV, NH, NC, ND, OH, OR, PA, TX, VT, VA, WI, or WY is $129,375 to $207,000

The pay range for this position in AK, DE, MD, NY, RI, or WA is $135,844 to $217,350

The pay range for this position in CA, CT, DC, MA, or NJ is $144,900 to $231,840

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 .

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.

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.

Salary : $122,906 - $196,650