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Prin Medical Writer
Ref No.: 18-27809
Location: Minneapolis, Minnesota
Open to remote candidates but would be more challenging not to be local to Minneapolis. We need them to be on site once in a while and will not pay to fly someone in.

The Prin Medical Writer/CER Specialist will have an in-depth knowledge of medical writing and will be responsible for developing Clinical Evaluation Reports (CERs). This individual will have demonstrated expertise in partnering with clinical research, regulatory affairs, quality/reliability, product development, and biostatisticians to develop schedules and timely execute tasks.
Analyze and synthesize vast amount of pre-clinical data, risk management assessments, published literature, clinical investigation results and field performance data in order to evaluate product safety and performance.
Interface with key functional areas (eg. Product core teams, clinical team, EU and US regulatory, marketing and risk management group) to obtain necessary information and documents required for the development of CER.

POSITION DESCRIPTION:
This is a medical writing position in Implantable Therapies Clinical Research for the Restorative Therapies Group. The CER Specialist will have an in-depth knowledge of medical writing and will be responsible for developing Clinical Evaluation Reports (CERs) This individual will have demonstrated expertise in partnering with clinical research, regulatory affairs, quality/reliability, product development, and biostatisticians to develop schedules and timely execute tasks. The individual will have demonstrated the ability to develop solutions to complex problems and ensures that solutions are consistent with objectives. The individual will have a broad expertise in collaborating on a number of clinical and regulatory documents. The role includes management of the clinical evidence report writing process to ensure compliance to regulations and expectations of Regulatory Bodies.

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POSITION RESPONSIBILITIES:
• Analyze and synthesize vast amount of pre-clinical data, risk management assessments, published literature, clinical investigation results and field performance data in order to evaluate product safety and performance.
• Interface with key functional areas (eg. Product core teams, clinical team, EU and US regulatory, marketing and risk management group) to obtain necessary information and documents required for the development of CERs.
• Therapeutic and device operation knowledge and apply this knowledge to clinical assessment and development of evaluation reports for corresponding product/s.
• May interface with regulatory agencies to discuss details of the clinical evaluation report
• Collaborate with cross-functional team to assure high quality and successful completion of deliverables
• Manage project schedule, timelines and deliverables
• May conduct literature review searches, ordering articles, conducting article reviews, and creating bibliographies

BASIC QUALIFICATIONS: EDUCATION/EXPERIENCE:
EDUCATION:
Bachelor's degree

EXPERIENCE:
• 5+ years experience (4+ years with Masters or 3+ with Doctorate, or Board Certified MD or DVM)
• Medical writing experience

DESIRED/PREFERRED QUALIFICATIONS: EDUCATION & JOB EXPERIENCE
• Clinical Research experience
• Medical device experience
• Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)
• Advance degree in related field (i.e. systems, reliability, safety engineering)

KNOWLEDGE & SKILLS/COMPETENCIES
• Previous experience in the application of in-depth therapeutic and device knowledge to development of clinical evaluation reports
• Analyzes complex issues and significantly improves, changes, or adapts existing methods.
• Proficient knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states, Neuromodulation therapies and technologies
• Ability to maintain composure in difficult circumstances, and identify and overcome obstacles
• Strong knowledge and understanding of Good Clinical Practices and regulatory standards
• Excellent critical and analytical thinking skills
• Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills
• Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development
• Strong ability to determine and pursue courses of action necessary to obtain desired results.
• Proficiency in word processing tools, spreadsheets, and/or database applications (e.g., MS Word and Excel)
• High attention to detail and accuracy
• Ability to identify customer/stakeholder requirements, and constructively respond to feedback/comments/inquiries
• Project management capability