Position: Medical Writer II

Location: Plymouth, MN 55442

Duration: 6 Months

Job Type: Contract

Work Type: Onsite

Shift Timings: Mon - Fri (8:00 AM - 5:00 PM)

Pay Rate: $38-$38.00/hour

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is a, passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. A leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets. Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services.

Job Description:

Qualifications:

• 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.
• High level of attention to detail
• Ability to prioritize key business objectives and respond quickly to changing priorities
• Ability to work independently with minimal daily instruction
• Able to multitask and work in a fast-paced environment
• Bachelor’s Degree required in related field
• Minimum of 2 years medical writing experience in the medical or pharmaceutical industry or 5 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
• PSUR writing experience strongly preferred
• Literature search experience is preferred
• Biomedical, sciences, medicine or similar health related discipline preferred

Physical Requirements and Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.

Responsibilities:

• Writes and contributes to Clinical Evaluation reporting deliverables including Post-Market Surveillance Plans and Periodic Safety Update Reports (PSURs), 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 regulatory submissions and the maintenance of clinical evaluation report files.
• Collaborates with team members and stakeholders in planning for and supporting PSUR 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, Quality Engineering, 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 Reports and Plans (CER/CEP), clinician 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 to regulatory submissions and communications, 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.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.