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Assoc Medical Writer (Assoc Clin Evidence Specialist)
8200 Coral Sea Street Northeast New Brighton, MN 55112 US
Job Description
HM's Top 3:
- Detail-oriented
- Quick learner
- Strong communication skills
Education Required: Bachelor’s degree
Years’ Experience Required: Entry level
40 hours/week
Onsite 3 days/week – Mounds View office
Responsibilities may include the following and other duties may be assigned.
- Creating/populating template content for project leads in accordance with QMS and policy standards
- With appropriate supervision and support from project lead, assist in developing and providing medical writing support for clinical evaluation documents such as Clinical Evaluation Plans and Reports, Post-Market Clinical Follow-up plans and reports, and more, in compliance with regulations and Medtronic policies and procedures.
- Conduct literature reviews and data extraction under supervision of project lead. May assist with facilitating cross-functional review team kick-off and conclusion meetings, and training for project leads
- With appropriate supervision and support, assist in reviewing and summarizing data from multiple sources (clinical investigation results, scientific literature and clinical experience, preclinical data, etc.) in order to evaluate product safety, performance and clinical benefits and identify potential evidence gaps.
- Report instances of complaints/adverse events from literature to GCH.
- Perform quality control check, compilation, formatting, and tabulation on clinical evaluation documents, as requested. Confirm data consistency and integrity across clinical evaluation documents.
- Coordinate the distribution of draft and final clinical evaluation documents to project team. Route final documents for approval and storage with appropriate database following good documentation practices.
- Create and manage project schedule for assigned documents in collaboration with project lead
- Develop sound knowledge of global clinical evaluation regulations and regulatory agencies’ guidelines on clinical evaluation requirements.
- May develop best practice guidelines/checklists for ensuring review comments are vetted and complete in partnership with team
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
- Bachelor’s degree in Life Sciences/ Health Related field or equivalent.
Nice to Have (Preferred Qualifications):
- Proficient knowledge of physiology and/or applicable disease states, medical terminology, CRM therapies and technologies
- Project management experience
- experience with medical and/or scientific writing
- experience within a medical device or pharmaceutical industry and basic understanding of clinical research.
- Experience with quality records, good documentation practices and/or 21 CFR Part 11 compliant filing systems.
- Demonstrated ability to work in a matrixed, global environment
- Demonstrated ability to communicate verbally clearly and effectively and in technical or scientific writing, clear and concise writing style
- Effective organizational, communication, and project team skills; high attention to detail and accuracy
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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