Job Description

Adecco is assisting a National Biotech company in hiring for a Medical Writer II Hybrid in Plymouth MN.

The anticipated wage for this position is between $35-38. Hourly wage may depend upon experience, education, geographic location and other factors.

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. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable ICU Medical SOPs.

Work Days:          M-F
Start Time:           8:00 AM
End Time:             5:00 PM

Being onsite while training is required, but not required once the person is trained.

Qualifications:
• 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

Travel Requirements
• Typically requires travel less than 5% of the time

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs.  Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria. 

If you or someone you know might be interested in this opening please reach out.

Pay Details: $35.00 to $38.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

Job Tags

Hourly pay, Holiday work, Contract work, Temporary work, For contractors, Local area,

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