Medical Writer IV

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition SpecialistPriyanka Mahantat email address Priyanka.mahant@generistek.com can be reached on #(630) 576-1940.

We haveContractrole Medical Writer for client atSanta Clara, CA.Please let me know if you or any of your friends would be interested in this position.

Position Details:

Medical Writer- Santa Clara, CA

Location        : 100% on site at Santa Clara, CA/ St. Paul, MN/ Maple Grove, MN/ Plano, TX

Project Duration: 12 Months of contract

Shift                : Daytime Hours (Mon-Fri) 40hrs/week

Pay Rate      : $67.00 per hour on W2

Job Description:

·        We currently have an opportunity for a Clinical Evaluation Reporting / Medical Writer (CER) for Vascular Medical Devices

·        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 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 YOU’LL DO

·        Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation 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), PMS Plan, PMCF Plans/Reports, SSCPs, 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 and Experience:

Required

·        Bachelor’s 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.

To discuss this amazing opportunity, reach out to our Talent Acquisition SpecialistPriyanka Mahantat email address Priyanka.mahant@generistek.com can be reached on #(630) 576-1940.

About generis Tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.