Senior Executive -Clinical Trail

Job Description

Job Title: Sr. Executive (Clinical) Medical Device Clinical Evaluation, Medical Writing and Publications. Location: Moraiya, Ahmedabad Job Type: Full-time Introduction: We are seeking a highly motivated and experienced PhD candidate with 3-4 years of experience to join our team, focusing on medical device clinical evaluation, medical/technical writing, publication writing and content creation. The ideal candidate will have a strong background in medical research, excellent writing skills, and a passion for communicating complex scientific information clearly and effectively. This is an exciting opportunity to contribute to cutting-edge developments in the medical device industry while supporting our clinical evaluation and content creation efforts. Key Responsibilities: Medical Device Clinical Evaluation: Contribute to the design, implementation, and reporting of clinical evaluation activities for medical devices for both planning and execution Review and analyze clinical data (State of Art Literature, Post market surveillance), ensuring compliance with regulatory requirements and industry standards. Collaborate with cross-functional teams, including R&D, regulatory affairs, and quality assurance and marketing/sales, to support clinical evaluation efforts. Assist in the preparation of Clinical Evaluation Reports (CERs) and accordingly publications/digital creations and promotional materials including all other regulatory documentation. Publication Writing: Draft, edit, and submit product related scientific publications for peer-reviewed journals, ensuring high-quality and accurate content. Collaborate with internal teams and external experts to develop manuscripts, posters, and presentations for medical conferences. Contribute to state of the art literature reviews and systematic reviews of point in question to support publication and research needs. To identify the journals for the publication of draft manuscripts. Medical Writing: Produce high-quality medical writing for various purposes, including regulatory submissions, clinical trial protocols, and other technical documents. Ensure all medical writing complies with relevant guidelines and standards, including Good Clinical Practice (GCP) and ISO/ICH standards. Develop clear and concise clinical and scientific documentation for both technical and non-technical audiences. Medical Content, Promotional & Blog Writing: Review the state-of-the-art literature, align it with post-market reviews of the products, collaborate with the risk management team, and ensure the review and documentation of the product IFU meet the state-of-the-art claim/indications requirements. Create engaging, informative, and scientifically accurate blog posts and articles related to medical devices, healthcare innovations, clinical evaluations, and related topics. Work with the in house teams to produce content that educates and informs our audience, enhances brand awareness, and supports thought leadership in the medical device sector. Literature Writing: Conduct literature reviews, summarize key findings, and identify emerging trends in medical device technology, clinical practices, and regulatory frameworks. Contribute to the preparation of white papers, technical reports, and other literature-based documents. PhD in a relevant field (e.g., Medical Sciences, Life Sciences, Biomedical Engineering, Pharmacology, etc.). 3-4 years of experience in medical device clinical evaluation, medical writing, or related fields. Strong understanding of regulatory guidelines, clinical evaluation methodologies, and the medical device industry. Proven track record of publishing in scientific journals and presenting at conferences. Exceptional writing and editing skills, with attention to detail and ability to simplify complex scientific concepts. Experience with literature review and systematic review methodologies. Ability to work independently and as part of a multidisciplinary team. Familiarity with medical content creation, including blogs, articles, and other digital content. Proficiency in Microsoft Office Suite and relevant writing software (e.g., EndNote, Reference Manager). Preferred Skills: Experience with clinical evaluation reports (CERs) and regulatory submissions (e.g., FDA, EMA). Familiarity with medical device regulations, standards, and industry guidelines (ISO 13485, MDR, etc.). Experience with content management systems (CMS) and SEO best practices. Strong organizational skills with the ability to manage multiple projects simultaneously and meet deadlines. Why Join Us: Opportunity to work at the forefront of medical device innovation and clinical evaluation. Collaborative and dynamic work environment with the potential for professional growth and development. Contribute to impactful publications and content that drive industry advancements. Competitive compensation and benefits package. How to Apply: Interested candidates are invited to submit a CV, cover letter, and writing samples (e.g., published articles, clinical reports, or other relevant work) to gm@aegis-lifesciences.com. We look forward to reviewing your application!