Medical Writer
You will be responsible for helping with authoring and maintaining clinical and post-market documentation such as CEPs, CERs, PMCFPs, and PMCFRs and contribute to our 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:
Enforces rigorous adherence to Good Documentation Practices, meticulously maintaining the quality and accuracy of document content and format to meet stringent regulatory standards and internal protocols, working under direct supervision.
Handles the development of clinical evaluation deliverables for new products and meticulously updates existing company CEPs, CERs, and PMCFP/Rs in strict accordance with MEDDEV 2.7.1, Rev. 4 guidelines and compliant with EU MDR regulations.
Compiles and synthesizes a wide array of data @types and sources-including clinical study results, post-market surveillance data, risk assessments, and published literature-to conduct comprehensive evaluations of medical device safety and performance, identifying potential evidence gaps and informing strategic decision-making.
Collaborates with the team to generate accurate and compliant documents by applying standard software tools and internal procedures, ensuring adherence to external standards, regulations, and guidelines. Engages with peers regularly to share knowledge, experiences, and best practices, fostering a collaborative environment for collective learning and professional development.
Analyzes complex issues and identifies opportunities to improve or adapt existing methods and processes to enhance efficiency and quality in document preparation and submission.
You're the right fit if:
You've acquired 1+ years in experience in clinical research or healthcare experience strongly preferred; knowledge of bedside patient monitoring beneficial; experience and skill in performing systematic searches of the medical/scientific literature using tools including Embase and PubMed, highly skilled with data extraction and related tools (e.g., Distiller, Zotero, EndNote).
Your skills include high comfortability and experience working within GDP and knowledge of relevant writing styles (e.g., AMA) and good publication practices (e.g., ICMJE); Strong knowledge of clinical research methodology, including study design, outcomes and measures, and biostatistics is preferred; strong ability to identify, mitigate and escalate risks, and strong ability to meet prioritize and meet multiple project deadlines. You have excellent written English and oral communications skills with strong attention to detail related to consistency, grammar, syntax, and accuracy.
You have a BS/BA in a scientific or medical discipline with 1+ years of experience in clinical evaluation report writing in the medical device industry OR an advanced degree (MS, MA, MPH, PharmD, PhD, MD) with no experience, preference for some experience related to 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, as well as a demonstrated 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. 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.
Discover our rich and exciting history.
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Learn more about our commitment to diversity and inclusion.
Philips Transparency Details
The pay range for this position in AZ, AR, ID, IA, KS, KY, LA, ME, MS, MO, NE, NM, OK, SC, SD, TN, UT, or WV is $66,500 to $114,000.
The pay range for this position in AL, CO, FL, GA, HI, IL, IN, MI, MN, NV, NH, NC, ND, OH, OR, PA, TX, VT, VA, WI, or WY is $70,000 to $120,000.
The pay range for this position in AK, DE, MD, NY, RI, or WA is $73,500 to $126,000.
The pay range for this position in CA, CT, DC, MA, or NJ is $78,400 to $134,400.
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.
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.
Company relocation benefits will not be provided for this position.
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.
Equal Employment and Opportunity Employer/Disabled/Veteran
