Medical Writer I in Plano, TX at Volt
Employee Type: Contingent
Location: Plano, TX
Job Type: Engineering Disciplines
Duration: 20 weeks
Date Posted: 6/5/2019
Job ID: 181794
Contact Name Volt Branch
Volt has an opening for a Medical Writer with our client in Plano Texas. We are looking for someone with experience in CER writing experience . Volt's Client is a leading healthcare company.
Under the direction of the Clinical Evaluation Report Project Manager (CER PM) and Director, will be asked to perform the following:
Author, review, quality control, and/or provide feedback, in accordance with Client processes and procedures, documents related to clinical evaluation of medical device products including: Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Post-Market Surveillance (PMS) Plan, Post-Market Clinical Follow-up (PMCF) Plan, PMCF Report, Summary of Safety and Clinical Performance (SSCP).
Document editing and quality control, generally include: quality review of accurate data presentation and bibliography, ensuring correctness of document content, preparing finalized documents for submission to document control, and managing literature screening projects with DistillerSR and EndNote.
Request PMS data and reports, and further analyze and synthesize these data and reports.
Summarize and synthesize other sources of data relevant to safety and performance of products, including: pre-clinical data reports, risk management assessment reports, published clinical literature, clinical investigation results and field performance data.
Interface regularly with the CER PM, and may interact with stakeholders from key functional areas (e.g., clinical team, EU and US regulatory, R&D, risk management, etc.) to obtain necessary information and documents (e.g., technical files, risk reports, IFU, etc.) required for CER content.
Develop therapeutic and device operation knowledge and apply this knowledge to clinical assessment.
Other relevant duties as required
Bachelor's degree required; Master's or PhD preferred with a focus in science, engineering, or medical fields.
2+ years of experience in a medical, clinical research, quality systems setting; regulatory experience in medical device or pharmaceuticals industry is preferred.
MUST have CER writing experience; preferably with Class III and/or implantable devices.
Understanding of regulations, standards and guidelines related to medical devices, clinical studies, and quality systems, including: 21 CFR (e.g., 803, 812, 814, 820, 822, and 830); MDD 93/42/EEC; AIMDD 90/385/EEC; EU MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
Effective written, verbal and presentation skills in English.
Strong command of medical terminology.
Highly-developed interpersonal skills, and strong attention to detail.
Advanced experienced with MS Office suite
This is a W2 position.
Direct inquiries only.
No 3 rd party submittals please.
This position is not available for Corp-to-Corp.
This position is not available for Associate Vendors.
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In order to promote this harmony in the workplace and to obey the laws related to employment, Volt maintains a strong commitment to equal employment opportunity without unlawful regard to race, color, national origin, citizenship status, ancestry, religion (including religious dress and grooming practices), creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), sexual orientation, gender identity, gender expression, marital or parental status, age, mental or physical disability, medical condition, genetic information, military or veteran status or any other category protected by applicable law.