WebCardio

Role Overview The Medical Affairs Manager will lead and oversee clinical and medical activities, ensuring high-quality, compliant, and evidence-based clinical research and communication. The role involves managing clinical studies, regulatory compliance, cross-functional collaboration, and scientific communication to support product development, marketing, and sales initiatives. Key Responsibilities: 1. Clinical Study Management • Design, plan, and manage clinical trials, including Real-World Evidence (RWE) studies. • Ensure adherence to Good Clinical Practices (GCP) and ethical guidelines. • Collaborate with investigators, Key Opinion Leaders (KOLs), and research sites. • Collect, analyse, and interpret post-marketing clinical data. • Conduct retrospective analyses of WebCardio data. • Lead prospective clinical trials, including protocol design, medical writing, and data analysis to ensure smooth execution. 2. Regulatory & Compliance Oversight • Ensure compliance with regulatory requirements (e.g., CDSCO) and internal standards. • Prepare clinical documentation for regulatory submissions and approvals. • Monitor evolving clinical and regulatory standards to ensure ongoing compliance. 3. Cross-Functional Collaboration • Partner with marketing, sales, and other functions to provide clinical insights that enhance strategy and product development. • Support sales teams in addressing clinical objections with evidence-based information. • Collaborate with KOLs to gather insights for ongoing and future projects. • Travel as required to support studies and stakeholder engagement. 4. Scientific & Medical Communication • Prepare clinical study reports, white papers, and publications. • Present clinical data at conferences, webinars, and to internal and external stakeholders. • Provide scientific training to KOLs, speakers, and the sales team as required. Qualifications & Experience: • Degree in Medicine, Pharmacy, or Life Sciences (MBBS,PHD,PharmD, or equivalent). • Proven experience in clinical study management, medical affairs, or regulatory roles in healthcare/medical device/biotech sectors. • Strong knowledge of GCP, clinical research methodology, and regulatory requirements. • Excellent communication, collaboration, and analytical skills.