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Senior Medical Writer
Philips - Rosemont, IL
posted 2 months ago
About the position
The Senior Medical Writer will be responsible for authoring and maintaining clinical and post-market documentation related to sleep and respiratory care products. This role involves contributing to clinical evaluation deliverables, compiling and analyzing data to evaluate product safety and performance, and ensuring compliance with regulatory requirements. The position requires interaction with cross-functional teams and managing timelines to meet deliverables while adhering to Good Documentation Practices.
Responsibilities
- Author and maintain clinical evaluation deliverables (CEPs, CERs, PMCFPs, PMCFRs) according to MEDDEV 2.7.1, Rev. 4 and EU MDR compliance.
- Compile, appraise, analyze, and synthesize data from various sources to evaluate product safety and performance.
- Acquire and maintain knowledge of business unit products, competitor devices, and current clinical/market developments.
- Interact with cross-functional teams to ensure compliance of clinical evaluations for new products requiring CE Mark.
- Manage timelines and communication to ensure deliverables and milestones are met.
- Prepare for and participate in audits as needed.
Requirements
- Experience in clinical research or healthcare, with knowledge of sleep and respiratory care therapies preferred.
- Strong experience in systematic searches of medical/scientific literature using tools like Embase and PubMed.
- Advanced knowledge of international regulatory requirements and standards (EU 2017/745, MEDDEV 2.7.1 Rev 4, ISO 13485, ISO 14155, ISO 14971).
- High comfortability working within Good Documentation Practices and knowledge of relevant writing styles (e.g., AMA).
- Strong knowledge of clinical research methodology, including study design, outcomes, and biostatistics.
- Excellent written and oral communication skills with strong attention to detail.
Nice-to-haves
- Experience with data extraction tools (e.g., Distiller, Zotero).
- Ability to identify, mitigate, and escalate risks effectively.
- Demonstrated ability to work and communicate effectively in a team environment.
Benefits
- Generous PTO
- 401k with up to 7% match
- HSA with company contribution
- Stock purchase plan
- Education reimbursement
- Annual incentive bonus
