Senior Medical Writer (Contract-to-Hire) Job at Blue Star Partners LLC, Maple Grove, MN

QWpPWmJnRFFFTW1DWUZBU1l0bVB6ZnFr
  • Blue Star Partners LLC
  • Maple Grove, MN

Job Description

Job Title: Senior Medical Writer (Contract-to-Hire)
Location: Maple Grove, MN (100% Onsite)
Period: 07/28/2025 to 07/24/2026

Hours/Week: 40 hours (Overtime paid at time and a half)

Rate: $40 - $50/hour Contract Type: W-2 only (U.S. work authorization required)

 
Scope of Services

The Sr. 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.

 
Role, Responsibilities & Deliverables

  • 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, 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), 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 & 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.

Job Tags

Contract work, Work experience placement

Similar Jobs

Aequor

Scientist Senior Job at Aequor

 ...exercise during the interview. Red flags: Pattern of moving from job to job in 1 to 1.5 year intervals, has NO past experience in human factors, has only been working within academia. Top 3 Must Have Skill Sets: 1. Very strong written communication skills with evidence of

Pawfect Pet Sitter

Join Pawfect Pet Sitter: Pet Sitter & Dog Walker - Cave Creek, AZ Job at Pawfect Pet Sitter

 ...Pawfect Pet Sitter is actively hiring a reliable pet sitter and dog walker who lives in Cave Creek or very close by . We are specifically...  ...reading. What You Will Do Provide daily check-ins, dog walks, and pet sitting visits in clients homes Care for pups of all... 

Vacation Advertiser

Travel Booking Agent Job at Vacation Advertiser

 ...Remote Travel Booking Agent: Full-Time or Part Time We are looking for travel booking agents to help clients plan and book their travel arrangements, such as flights, hotels, rental cars, and vacation packages. The job requires excellent customer service skills,... 

MicroDental Laboratories

Dental Technician Trainee Job at MicroDental Laboratories

 ...packages and great long-term stability. We operate in over 25 locations in North America as both MicroDental Laboratories and Modern Dental Laboratory USA. With our focus on Quality, Value, and Legendary Customer Care, our Centers are devoted to building strong and... 

Sharing Excess

Food Rescue Delivery Driver Job at Sharing Excess

 ...Point Produce Market, Hunts Point, NY Job Description: Food Rescue Drivers will assist in picking up surplus, soon-to-expire...  ...restaurants, and wholesalers. Drivers will primarily complete deliveries in our XL Sprinter Van, where boxes of food donations are hand-...