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Medical Writer II

2 months ago

Saint Paul, Minnesota, United States Blue Star Partners LLC Full time
Job Title: Medical Writer II

Job Summary:

We are seeking a highly skilled Medical Writer II to join our team at Blue Star Partners LLC. As a Medical Writer II, you will be responsible for providing technical and strategic writing expertise throughout the product development and life cycle process.

Key Responsibilities:

  • Writes and contributes to Clinical Evaluation reporting deliverables such as Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses, and other related documentation.
  • Evaluates and summarizes clinical evidence, including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations.
  • Collaborates with team members and stakeholders in planning for and supporting CER-related projects and processes.
  • Supports additional clinical, regulatory, quality, and engineering-related deliverables as assigned.
  • Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management, and Medical Affairs in completing clinical evaluation project-related deliverables.
  • Maintains thorough knowledge of assigned products and identifies appropriate sources of relevant data, interprets, evaluates, and incorporates information from various sources.
  • Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), physician training materials, ensuring alignment of risk information.
  • Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews, and other processes such as regulatory inquiries.
  • Ensures quality in all deliverables and documentation with attention to detail, consistency, and integrity of data.

Requirements:

  • Bachelor's Degree required, along with 4 to 6 years of experience.
  • People with clinical experience, 4 to 6 years of experience in this area or clinical studies and report writing within the Medical Device area.
  • Ability to work independently after initial onboarding.
  • Ability to work with teams of people in a teamwork setting with Project Managers and the business to create documents that are fairly large in volume.
  • Writing experience in a medical, pharmaceutical, medical device, clinical research, medical, or research industry, or combination of these skills.
  • CER writing experience required.

Preferred Skills:

  • Biomedical, sciences, medicine, or similar health-related discipline preferred.
  • Excellent written and verbal communication skills.
  • Experience with collaborative, cross-functional teams.
  • Excellent analytical skills and ability to manage complex tasks and manage time effectively.
  • Proficient with Word, Excel, PowerPoint, Outlook, etc. Experience working within a Matrix Organization and Cross-Functional Teams.
  • Project Management experience where they owned their own projects and supported multiple technical projects.
  • MS Excel - Intermediate Level as they will leverage this as a tool to manage projects, data extracting, and screening, Word, and Technical Knowledge.
  • Citation Management Systems experience - they use Endnote but can come with other systems knowledge and experience and will train on theirs.