Medical Writer

Philips•Murrysville, PA

13d•$71,250 - $134,400

About The Position

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 sources—including clinical study results, post-market surveillance data, risk assessments, and published literature—to 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.

Requirements

Experience in scientific writing (publications, white papers, brochure writing, etc.) required
High comfortability and experience working within GDP and knowledge of relevant writing styles (e.g., AMA) and good publication practices (e.g., ICMJE)
Strong ability to identify, mitigate and escalate risks, and strong ability to meet prioritize and meet multiple project deadlines
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.)
PhD/MD/PharmD in a scientific or medical discipline required
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
Ability to learn quickly and self-educate on different medical device products and procedures
Strong project/timelines management skills and organizational skills
Demonstrated to work and communicate effectively in a team environment including leading discussions and presenting to internal business and regulatory stakeholders

Nice To Haves

Medical writing experience in the medical device industry strongly preferred.
Strong knowledge of clinical research methodology, including study design, outcomes and measures, and biostatistics is preferred

Responsibilities

Authoring and maintaining clinical and post-market documentation such as CEPs, CERs, PMCFPs, and PMCFRs
Authoring other technical documents that support Clinical, Regulatory, Risk Management, or Post-Market Surveillance efforts (e.g., Clinical Evidence Strategies, Benefit-Risk Determinations, PSURs)
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 sources—including clinical study results, post-market surveillance data, risk assessments, and published literature—to 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.

Benefits

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.

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