Associate Medical Writer - St Paul, United States - Integrated Resources, Inc ( IRI )

Description

Job Description

HM's Top 3:

• Detail-oriented.
• Quick learner
• Strong communication skills

Education Required: Bachelor's degree.

Years' Experience Required: 0 years of experience.

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 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