Medical Writer II

2 weeks ago

Maple Grove, United States Experis Full time

Our client, medical device manufacturing industry,?is seeking a medical writer to join their team.

Job Title:?Medical Writer?
Location: Maple Grove, MN, 100% Onsite?
Duration: 12 months from the workers' start date
Pay Range: $40-$45/hr on W2

?

What’s the job?


Nature of role: authoring clinical evaluation reporting documents for the neuromodulation, CAHF, and vascular products. Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed.
* • Writes and contributes to clinical evaluation reporting deliverables, including clinical evaluation plans/reports, PMS and PMCF 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 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. Identifies appropriate sources of relevant data and 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), 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 Abbott SOPs and DOPs.
EDUCATION AND EXPERIENCE
Required
• Bachelor’s Degree or an equivalent combination of education and work experience
• 4-6 years of medical writing experience in the medical or pharmaceutical industry or 7+ 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, Outlook, etc.

If this is a role that interests you and you’d like to learn more, click apply now, and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you

?

About ManpowerGroup, Parent Company of:??Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup? (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands—Manpower, Experis, Talent Solutions, and Jefferson Wells—creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity—as the best place to work for women, inclusion, equality, and disability—and in 2022, ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year—all confirming our position as the brand of choice for in-demand talent.

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