Senior Medical Writer

$116,200 - $199,200/Yr

Philips - Colorado Springs, CO

Full-time - Senior

Colorado Springs, CO

Repair and Maintenance

About the position

The Senior Medical Writer will play a crucial role in authoring and maintaining clinical and post-market documentation for Philips' Sleep & Respiratory Care products. This position involves contributing to various technical documents that support clinical, regulatory, risk management, and post-market surveillance efforts, ensuring compliance with international regulatory standards and internal policies.

Responsibilities

• Author and maintain clinical evaluation deliverables (CEPs, CERs, PMCFP/Rs) according to MEDDEV 2.7.1, Rev. 4 and EU MDR compliance.
• Compile, appraise/analyze, and synthesize data from clinical studies, post-market surveillance, and published literature to evaluate product safety and performance.
• Maintain thorough 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, complying with Good Documentation Practices.

Requirements

• Minimum of BS/BA in a scientific or medical discipline with at least 7 years of experience in clinical evaluation report writing in the medical device industry, or an advanced degree (MS, MA, MPH, PharmD, PhD, MD) with at least 2 years of direct experience.
• 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).
• Excellent written and oral communication skills with strong attention to detail.

Nice-to-haves

• Experience with data extraction tools (e.g., Distiller, Zotero).
• Knowledge of clinical research methodology, including study design and biostatistics.
• Ability to identify, mitigate, and escalate risks effectively.

Benefits

• Generous PTO
• 401k with up to 7% match
• HSA with company contribution
• Stock purchase plan
• Education reimbursement