Medical Writer IV

Techlink Systems Inc.; Maple Grove (MN); On-site; USD 95,000 - 125,000; Full time

Job summary

Techlink Systems Inc. in Maple Grove, MN (onsite) seeks an experienced Medical Writer IV to develop Clinical Evaluation documentation and support regulatory submissions.

The role operates on a daytime schedule under a contract ending 10/15/2027, with an on-site work arrangement. The candidate should have 6-8 years of medical writing experience in the medical/pharmaceutical sector or 8+ years in technical writing, and possess strong communication and collaboration skills.

Qualifications

• Bachelor's Degree or equivalent required.
• 6-8 years medical writing experience in the medical or pharmaceutical industry or 8+ years general technical writing experience required.
• Experience with clinical, regulatory, quality and medical device documentation.

Responsibilities

• Writes and contributes to Clinical Evaluation reporting deliverables including CERs, CEPs and regulatory responses.
• Evaluates and summarizes clinical evidence from literature, investigations, PMS and post-market data.
• Collaborates with cross-functional teams on CER-related projects and processes.
• Supports regulatory, quality and engineering deliverables as assigned.
• Communicates with Sales, Marketing, R&D, Regulatory Affairs and other groups to complete CER-related deliverables.
• Maintains knowledge of assigned products and interprets data from various sources.
• Reviews IFUs, patient guides and risk files for alignment of risk information and regulatory inquiries.
• Authors documents for regulatory submissions and risk reviews.

Skills

Communication skills

Analytical skills

Time management

Cross-functional teamwork

Education

Bachelor's degree

Biomedical/health sciences preferred

Tools

Word

Excel

PowerPoint

Outlook

Job description

Job Title: Medical Writer IV
Location (On-site, Remote, or Hybrid?): Maple Grove, MN (onsite)
Contract Duration: Contract until 10/15/2027
Work Hours: Daytime hours
Total Hours: 40

WHAT YOU'LL DO

• Writes and contributes to Clinical Evaluation reporting deliverables including 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. Analyzes results in preparation for product applications and submissions.
• Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
• Supports additional clinical, regulatory, quality and engineering related deliverable 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. Identifies appropriate sources of relevant data, interprets, evaluates, and incorporates information from various sources including literature, clinical data, and medical references.
• Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), PMS Plan, PMCF Plans/Reports, SSCPs, physician training materials, ensuring alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
• 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. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance's (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable SOPs and DOPs.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

• Bachelor's Degree or an equivalent combination of education and work experience
• 6-8 years of medical writing experience in the medical or pharmaceutical industry or 8+ years general technical writing experience required
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills

Preferred

• Biomedical, sciences, medicine or similar health related discipline preferred
• CER writing experience 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, Outlo