Philips is hiring: Senior Medical Writer in Nashville

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 with EU MDR.
2. Responsible for 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 to identify potential evidence gaps.
3. Acquire/maintain thorough knowledge of business unit products, competitor devices, current clinical/market developments, and literature review processes while remaining current with relevant regulatory requirements.
4. Interaction with cross-functional teams to ensure compliance of the clinical evaluation for new products requiring CE Mark and ensuring compliance with internal policies and procedures.
5. Manage timelines and communication to ensure deliverables and milestones are met; comply with Good Documentation Practices to ensure quality and accuracy of document content and format; and prepare for and participate in audits, as needed.

You're the right fit if:

1. You have experience in clinical research or healthcare experience strongly preferred; knowledge of sleep and respiratory care therapies preferred.
2. You have strong experience and skill in performing systematic searches of the medical/scientific literature using tools including Embase and PubMed, and are highly skilled with data extraction and related tools (e.g., Distiller, Zotero).
3. Advanced knowledge and experience with international regulatory requirements, standards, 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 is required.
5. You have excellent written English and oral communication skills with strong attention to detail related to consistency, grammar, syntax, and accuracy.
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) strongly preferred with at least 2 years of direct experience in clinical evaluation report writing in the medical device industry.

You must be able to successfully perform the following minimum Physical, Cognitive, and Environmental job requirements with or without accommodation for this position.

You’re a self-starter with an ability to learn quickly and self-educate on different medical device products and procedures, have strong project/timelines management skills and organizational skills, and demonstrate the ability to work and communicate effectively in a team environment including leading discussions and presenting to internal business and regulatory stakeholders.

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. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is a field-based role.

About Philips

We are a health technology company committed to providing quality healthcare to everyone. Join us to improve the lives of others.

Compensation

The pay range for this position varies by location, with a range of $122,906 to $231,840 based on geographic location and experience. Additional compensation may include bonuses and benefits such as a generous PTO, 401k, HSA, and education reimbursement.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Philips is an equal opportunity employer committed to a diverse workforce. Reasonable accommodation for individuals protected by the Rehabilitation Act and the Americans with Disabilities Act is available upon request.

Equal Employment and Opportunity Employer/Disabled/Veteran

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