Clin Eval Med Writer- ProductF

Clin Eval Med Writer- ProductF
Location: Remote/Remote in CO/MN or Local-Lafayette, CO 80026, Minneapolis, MN
Duration: 12 Months+
Shift: 1st Shift.
Pay Range $50-$61.15/hr on w2
Interview:
1st Round: MS Teams Video with one HM
2nd Round: Once qualify after 1st Round- written assessment test
3rd Round: MS Teams Video with 2nd HM

TECHNICAL SKILLS
Must Have

• Advances use of work document
• EU MDR knowledge
• Literature analysis for PSUR and CE documents
• Microsoft Skills
• ProductFR
• PSUR Medical Writer
• Understanding of EU MDR safety and Performance

Nice To Have

• 10+ of project management 5+ years of Program management

HM's Top Needs:

• Experience in PSUR and ProductF writing in compliance with the European Union Medical Device Regulation (EU MDR), including PMS data analysis and riskbenefit 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:

BS- 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

Years Experience Required:

Minimum 3 years, maximum 10 years of relevant experience in PSUR and ProductF writing, clinical evaluation, or post-market surveillance.

Responsibilities may include the following and other duties may be assigned:

• Author Periodic Safety Update Report and Post Market Clinical Follow Up Plan/Reports.
• Experience 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 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, Product 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, or advanced degree with 0 years of experience.