Description

We are looking for below resources in our Chennai location Primary responsibilities: • Contribute independently and/or support team in drafting and editing documents as required in conducting and reporting the results of clinical and nonclinical studies, in the development of initial and update of Clinical Evaluation reporting deliverables including CEP, CER, PSUR, PMS plan, PMCF plan/reports, SSCPs, Regulatory responses and other related documents for medical devices. • Experiences in Scientific research and writing in Cardiology which involves writing, editing, proofreading and peer-reviewing documents (includes original, experimental study, case reports, literature reviews, meta-analysis and systematic review), clinical documents and documents intended for regulatory submissions. • Conducts complex literature searches, finalizes into written summaries for Safety & Performance sections, or for safety update annual reports. Researching industry-related topics and deliver plagiarism-free content. • Manages in the preparation of such documents, meetings, developing and managing timelines. • Adheres to job-specific instructions, procedures, practices, technical and industry standards during all aspects of work. • Ability to work within the set deadline. The correctness of content, terminology, flow, transition, and coherence. • Works effectively with cross-functional groups. Qualifications • Bachelor's or Master's in a life science or biomedical engineering discipline preferred or expertise in Cardiology. • Strong understanding and experience with Cardiology devices would be an advantage. • 2+ years (Junior engineers), 4+ years (Senior engineers) life sciences clinical and regulatory writing experience. • Expert knowledge of standard clinical regulatory document types. • Excellent writing and editing skills and attention to detail (prior writing experience would be an advantage). • Experience working in Medical Device Regulatory documentation. • Willingness and ambition to learn and take on new skills. • Proven proactive approach to your work. • Highly motivated.

Role and Responsibilities

• We are looking for below resources in our Chennai location Primary responsibilities: • Contribute independently and/or support team in drafting and editing documents as required in conducting and reporting the results of clinical and nonclinical studies, in the development of initial and update of Clinical Evaluation reporting deliverables including CEP, CER, PSUR, PMS plan, PMCF plan/reports, SSCPs, Regulatory responses and other related documents for medical devices. • Experiences in Scientific research and writing in Cardiology which involves writing, editing, proofreading and peer-reviewing documents (includes original, experimental study, case reports, literature reviews, meta-analysis and systematic review), clinical documents and documents intended for regulatory submissions. • Conducts complex literature searches, finalizes into written summaries for Safety & Performance sections, or for safety update annual reports. Researching industry-related topics and deliver plagiarism-free content. • Manages in the preparation of such documents, meetings, developing and managing timelines. • Adheres to job-specific instructions, procedures, practices, technical and industry standards during all aspects of work. • Ability to work within the set deadline. The correctness of content, terminology, flow, transition, and coherence. • Works effectively with cross-functional groups. Qualifications • Bachelor's or Master's in a life science or biomedical engineering discipline preferred or expertise in Cardiology. • Strong understanding and experience with Cardiology devices would be an advantage. • 2+ years (Junior engineers), 4+ years (Senior engineers) life sciences clinical and regulatory writing experience. • Expert knowledge of standard clinical regulatory document types. • Excellent writing and editing skills and attention to detail (prior writing experience would be an advantage). • Experience working in Medical Device Regulatory documentation. • Willingness and ambition to learn and take on new skills. • Proven proactive approach to your work. • Highly motivated.