Medical Affairs Manager

19 hours ago

Delhi, Delhi, India Gadgeon Medical Systems Pvt Ltd. Full time

About Webcardio

Webcardio is a leading provider of innovative cardiac monitoring solutions, offering Doctors and patients real-time, remote cardiac diagnostics through advanced wearable ECG technology. Our mission is to improve cardiac care delivery using AI driven insights and seamless technology.

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.
  • Place of work- Delhi/NCR (WFH)
  • Min 3+ Years of experience
  • Travel- 25% of time and depends on study requirements.

Job Types: Full-time, Permanent

Pay: ₹800, ₹1,200,000.00 per year

Application Question(s):

  • Current CTC
  • Expected CTC

Education:

  • Bachelor's (Required)

Experience:

  • clinical study management: 2 years (Required)

Location:

  • Delhi, Delhi (Required)

Willingness to travel:

  • 25% (Required)

Work Location: Remote

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