Philips Senior Medical Writer in Phoenix, Arizona
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.
- Acquiring/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.
- Preparing for and participating in audits, as needed.
You're the right fit if:
- You have experience in clinical research or healthcare experience strongly preferred; knowledge of sleep and respiratory care therapies preferred.
- You possess 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).
- You have 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).
- You have strong knowledge of clinical research methodology, including study design, outcomes and measures, and biostatistics; strong ability to identify, mitigate and escalate risks.
- You possess excellent written and oral communication skills with strong attention to detail related to consistency, grammar, syntax, and accuracy.
- 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.
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.
About Philips
We are a health technology company dedicated to providing quality healthcare to everyone. Do the work of your life to help improve the lives of others.
The pay range for this position varies by state. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, and geographical location.
In addition, other compensation, such as an annual incentive bonus, may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants without regard to protected characteristics.
As an equal opportunity employer, Philips is committed to a diverse workforce. Applicants that require accommodation in the job application process may contact 888-367-7223 for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran
#J-18808-Ljbffr