Medical Writer III Job at Actalent in Maple Grove
Actalent, Maple Grove, MN, United States, 55311
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Description
Medical Writer III Our location in Maple Grove MN currently has an opportunity for a Principal Clinical Evaluation Reporting / Medical Writer CER The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to 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. WHAT YOULL DO - 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 deliverable as assigned. - Effectively communicates and collaborates with Sales and Marketing RD 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 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 guidances ISO13485 ISO14155 ISO14791 MEDDEV 2.7.1 MDR and EU and FDA guidance documents and applicable Abbott SOPs and DOPs. EDUCATION AND EXPERIENCE YOULL BRING Required - Bachelors 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 Outlook etc.
Description
Medical Writer III Our location in Maple Grove MN currently has an opportunity for a Principal Clinical Evaluation Reporting / Medical Writer CER The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to 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. WHAT YOULL DO - 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 deliverable as assigned. - Effectively communicates and collaborates with Sales and Marketing RD 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 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 guidances ISO13485 ISO14155 ISO14791 MEDDEV 2.7.1 MDR and EU and FDA guidance documents and applicable Abbott SOPs and DOPs. EDUCATION AND EXPERIENCE YOULL BRING Required - Bachelors 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 Outlook etc.
Experience Level
Expert Level
Pay And Benefits
The pay range for this position is $65.00 - $67.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
Available For This Temporary Role May Include The Following
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
This is a hybrid position in Maple Grove,MN.
Application Deadline
This position is anticipated to close on Aug 8, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Contract
Job function
Job function
Marketing, Public Relations, and Writing/EditingIndustries
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