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Company: HCL America, Inc.
Location: Santa Clara, CA and various unanticipated locations throughout the U.S.
Job Title: Senior Lead – Medical Writing (HCLA53)
Multiple positions available

Job Description:

Plan and execute clinical documents for medical devices related to EU regulatory compliance including clinical evaluation, post-market clinical follow-up (PMCF), periodic safety update report and other clinical/Post Market Surveillance (PMS) documents related to EU MDR regulations for Medication Delivery, Surgery, and Critical Care Devices. Plan and execute clinical documents for in-vitro diagnostic devices related to EU regulatory compliance for the performance evaluation including analytical and scientific validity reports. Provide guidance and expertise for clinical evidence substantiation in context of post market clinical follow-up and EU MDR and EU IVDR requirements. Evaluate the clinical context for Clinical Evaluation Report (CER) through reviewing peer reviewed journal manuscripts, data sheets, white papers, standards, guidelines, and other technical communication materials. Perform proactive and reactive PMS data analysis and medical review. Review and approve Risk Management File documents (FMEA, RBA, etc.). Perform medical review for serious adverse event (SAE) reports. Collect and compile available clinical evidence for CER updates (clinical study outcomes, post-market surveillance data, PMCF updates, etc.) and completion of post-market surveillance documents. Liaise with cross-functional teams such as R&D, design quality engineering, post-marketing surveillance and regulatory affairs relating to clinical evaluation and post market clinical follow-up process. Prepare files for notified body submission and coordinate with notified body for the approval process. Develop standardized operating procedures for conducting post market clinical follow-up studies. Prepare post market clinical follow-up study protocol, survey design and healthcare professional survey questionnaire. Validate clinical trial protocols, investigator’s brochure, and informed consent forms. Ensure accurate, high-quality documents are delivered on schedule as per the regulatory timelines. Travel and work at client sites as assigned.

Job Requirements:

Requires Master’s degree or foreign equivalent in Pharmaceutical Science, Computer Science, Engineering (Any), Information Technology, Computer Technology, Computer Information Systems, Management Information Systems or related field plus one (1) year of experience in the job offered, or related IT or engineering role. Will accept a Bachelor’s degree plus five (5) years of described experience in lieu of Master’s degree plus one (1) year of described experience. Any suitable combination of education, training, or experience is acceptable. Base Salary: $295,194 - $296,000/Year (whatever range we reasonably expect to hire a candidate within based upon our internal salary grid). Exact compensation may vary based on skills, experience, education, and/or to comply with federal or state law. Travel and work at client sites as assigned.

How to apply: Email resume, referencing HCLA53, including job history, to: HanimireddyV@hcl.com. HCL America, Inc.is an Equal Opportunity Employer.