Job Information
Philips Medical Writer in Bend, Oregon
Medical Writer
In this role you
This role is responsible for preparation of Clinical Evaluation Reports (CERs), Post Market Clinical Follow-Ups (PMCFs), Investigator Brochures (IBs) documents and the document templates and processes that support their creation. Also, responsible for preparation of presentations, publications, study reports, white papers and regulatory writing needs of Philips Clinical Affairs Department
Your role:
Collect, appraise and analyze clinical data pertaining to a medical device.
Write documentation, such as Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) Reports, Investigator Brochures (IBs) for supporting regulatory submissions and studies.
Ensure appropriate interpretation and dissemination of all evidence generated, including writing Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) Reports, and supporting the timely publication of study results.
Assist with and create procedures and workflows related to medical writing for the Ultrasound Clinical Affairs group. Collaborate with internal (project owners, regulatory, study managers, statisticians, business leaders, post-market surveillance, risk management, etc.) and external (clinical consultants, subject matter experts, regulatory agencies) partners to ensure comprehensive analysis of clinical evidence.
Support development of evidence generation strategies, in line with the value proposition that addresses the evidence needs for the project and stakeholders, including review and development of study protocols and clinical study reports (CSRs).
You're the right fit if:
Bachelor's in Life Science required with 3+ years of experience. MS, MA, MPH, PharmD, PhD, MD degree preferred in Biomedical Science or Health-related field, 5+ years of experience in Medical Writing preferred.
Demonstrated solid understanding of EU regulations, Good Clinical Practice and ICH guidelines. Experience with research methodology (including clinical investigation design and biostatistics) and interpretation. Experience with relevant medical & scientific literature databases and strong medical writing skills to produce quality clinical documents.
Experience writing MEDDEV 2.7.1 rev 4 and MDR compliant CERs, PMCFs is a requirement. Experience writing Investigator Brochures (IBs), Clinical Study Reports and White Papers is a plus.
Proven track record of delivering clinical results, on time, within budget, and in compliance with SOPs and regulations.
Knowledge of Good Clinical Practice (GCP), FDA regulations and ISO 14155, a plus
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
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.
We prefer that this is an office role, but can be home-based.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Learn more about our commitment to diversity and inclusion (https://www.careers.philips.com/na/en/diversity-and-inclusion) .
Philips Transparency Details
The pay range for this position in Bothell WA is $90,000 to $150,000, Annually.
The pay range for this position for Home based is $90,000 to $140,000, Annually.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here (https://www.philipsusbenefits.com/) .
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
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.
#LI-PHI
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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