Philips is hiring: Senior Medical Writer in Baltimore

Philips Senior Medical Writer in Baltimore, Maryland

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 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:

1. 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.
2. 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 identify potential evidence gaps.
3. Maintaining thorough knowledge of business unit products, competitor devices, and current clinical/market developments.
4. Interacting with cross-functional teams to ensure compliance of the clinical evaluation for new products requiring CE Mark.
5. Managing timelines and communication to ensure deliverables and milestones are met; complying with Good Documentation Practices to ensure quality and accuracy of document content and format.

You're the right fit if:

1. You have experience in clinical research or healthcare; knowledge of sleep and respiratory care therapies preferred.
2. Strong experience in performing systematic searches of medical/scientific literature using tools like Embase and PubMed.
3. Advanced knowledge and experience with international regulatory requirements and guidance (EU 2017/745, MEDDEV 2.7.1 Rev 4, ISO 13485, ISO 14155, ISO 14971, applicable MDCGs).
4. Strong knowledge of clinical research methodology, including study design, outcomes and measures, and biostatistics.
5. Excellent written and oral communication skills with strong attention to detail.
6. You have a 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.

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.

About Philips:

We are a health technology company committed to improving lives through meaningful innovation.

Additional Information:

US work authorization is a precondition of employment. Philips is an equal opportunity employer.

#J-18808-Ljbffr