Philips is hiring: Senior Medical Writer in Baltimore
Philips, Baltimore, MD, United States, 21276
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:
- 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.
- 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.
- Maintaining thorough knowledge of business unit products, competitor devices, and current clinical/market developments.
- Interacting with cross-functional teams to ensure compliance of the clinical evaluation for new products requiring CE Mark.
- 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:
- You have experience in clinical research or healthcare; knowledge of sleep and respiratory care therapies preferred.
- Strong experience in performing systematic searches of medical/scientific literature using tools like Embase and PubMed.
- 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).
- Strong knowledge of clinical research methodology, including study design, outcomes and measures, and biostatistics.
- Excellent written and oral communication skills with strong attention to detail.
- 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.
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