Sr. Executive Clinical

Job Title: Sr. Executive (Clinical) â 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.

Qualifications:

• 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!