UsefulBI Corporation
Website:
usefulbi.com
Job details:
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).
Good 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.
Click on Apply to know more.
