Job Title: Medical Affairs SME

Location: Bangalore / Lucknow / Pune

Type: Full-time

Company’s website: https://usefulbi.com

LinkedIn link: UBI LinkedIn

About UsefulBI:

UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.

Role Overview:

We are seeking a Medical Affairs SME with 7+ years of experience in the pharmaceutical or life sciences industry. The ideal candidate will serve as the scientific and medical expert , bridging clinical knowledge, compliance requirements, and business objectives. This role involves collaborating with cross-functional teams, engaging with stakeholders, ensuring compliance, and supporting evidence-based decision-making across projects.

Key Responsibilities:

- Act as the subject matter expert for therapeutic areas, medical strategy, and compliance requirements.
- Review and validate scientific content, clinical trial data, regulatory submissions, and publications .
- Provide scientific and medical training to internal teams (sales, regulatory, data, marketing).
- Ensure compliance with pharma regulations (21 CFR Part 11, ICH-GCP, GxP, HIPAA).
- Partner with R&D;, regulatory, pharmacovigilance, and commercial teams to provide medical/scientific input.
- Collaborate with Key Opinion Leaders (KOLs), clinicians,



and advisory boards to gather insights.
- Support clinical trial design, real-world evidence (RWE) studies, and data interpretation .
- Develop and review BRDs, SOPs, and medical documents ensuring accuracy and compliance.
- Provide medical governance and oversight for promotional and non-promotional activities.

Required Skills and Qualifications:

- Consulting Expertise: Proven experience in a consulting role, managing client expectations with confidence.
- 7+ years of experience in Medical Affairs / Clinical Research / Scientific Advisory roles in pharma, biotech, or CROs.
- Advanced degree (MD, PharmD, PhD, or M.Pharm) in Life Sciences, Medicine, or Pharmacy .
- Strong understanding of clinical trial processes, medical writing, pharmacovigilance, and regulatory compliance .
- Familiarity with 21 CFR Part 11, GxP, ICH-GCP, HIPAA .
- Excellent skills in scientific communication, stakeholder management, and medical governance .
- Ability to interpret and communicate complex clinical/scientific data .
- Strong collaboration skills with cross-functional teams (regulatory, R&D;, commercial, data engineering).

Positive To Have:

- Exposure to Real World Evidence (RWE), HEOR (Health Economics & Outcomes Research) .
- Experience with data analytics tools (basic R, Python, or SAS).
- Knowledge of medical content management platforms (e.g., Veeva Vault, Medidata).
- Prior involvement in digital transformation of Medical Affairs .

📌 Medical Affairs Specialist (Bangalore Metropolitan Area)
🏢 UsefulBI
📍 Bangalore Metropolitan Area