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Remote Clin Eval Med Writer
Job Description
Pay 45-55/h depending on experience
HM's Top Needs:
- Experience in PSUR and PMCF writing in compliance with the European Union Medical Device Regulation (EU MDR), including PMS data analysis and risk–benefit evaluation.
- Strong expertise in clinical literature analysis, including systematic searches, critical appraisal, and clinical data synthesis.
- Solid project management skills with the ability to manage timelines, coordinate stakeholders, and ensure timely deliverables.
- Proficient in Microsoft Office, particularly advanced MS Word (structured formatting, templates, track changes, and document control).
Education Required:
Baccalaureate degree (Preferred Degree in Life Sciences, Pharmacy, Medicine, Biomedical Engineering, or Public Health, ideally with training in Clinical Research or Regulatory Affairs. : 2yrs-5yrs (see job description in VNDLY)
Years’ Experience Required:
Minimum 3 years, maximum 10 years of relevant experience in PSUR and PMCF writing, clinical evaluation, or post-market surveillance.
Will the contractor be working 40 hours a week? If not, weekly estimate?
Yes
Work Location: On-site preferred; remote work is acceptable depending on candidate profile pool and experience.
Do they need to be local to any MDT office and if so where? No, but if they local to Lafayette, Colorado or MN campus that would be great, otherwise remote is acceptable.
Responsibilities may include the following and other duties may be assigned.
Author Periodic Safety Update Report and Post Market Clinical Follow Up Plan /Reports.
Expereince with EU MDR Regulation
Review and summarize scientific literature. Reports instances of complaints/adverse events from literature to GCH. Create responses for audit/submission queries. Maintains database of peer-reviewed literature. Appraise, analyze, summarize, and discuss clinical evidence from all the available sources. Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence. Develop state of the art on product family for its intended purpose. Create & maintain plans and reports for regulatory authorities. Review/approve other documentation for device development. Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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