Business Analyst - Medical Writing

Company Description

RxCloud is a professional services organization dedicated to the Pharma, Biotech, and Medical Device industries, offering innovative solutions and ensuring compliance for clients worldwide. Committed to accelerating drug development lifecycles, RxCloud provides a comprehensive range of services, including CSV services, GxP audits (GMP, GDP, GLP, GCP, GVP), and Software Quality Assurance. Our core competencies include QMS consulting, global audit management, CAPA management, and SOP authoring. By prioritizing speed and agility, RxCloud strives to achieve compliance effectively and efficiently on the first attempt, delivering exceptional quality and customer experience.

📝 Hiring: Business Analyst (Medical Writing Domain) | Pune | 5+ Years Experience

Location: Pune

Experience: 5+ Years

Company: RxCloud

RxCloud is hiring a Business Analyst with strong Medical Writing experience to bridge the gap between clinical documentation teams, data sources, and business stakeholders. If you understand both the technical and clinical writing sides of the process, we want you on our team!

🔹 Key Responsibilities

Act as the primary liaison between medical writing, clinical operations, biostatistics, and IT/product teams.

Understand and document the structure, purpose, and workflow of key medical writing deliverables such as Clinical Study Reports (CSR), Informed Consent Forms (ICF), and other regulatory documents.

Analyze data sources used for authoring (protocols, statistical outputs, listings) and map how they connect to various writing stages.

Work with cross-functional teams to identify inefficiencies, gaps, and operational challenges in the medical writing lifecycle.

Translate business needs into clear functional requirements, user stories, and workflow documentation.

Support process optimization, tool implementation, and automation initiatives in medical writing.

Understand “day-in-the-life” scenarios of medical writers and help design solutions that improve quality, speed, and compliance.

Participate in reviews, ensure proper version management, and maintain documentation standards.

🔹 Requirements

5+ years of experience in the Life Sciences domain, with at least 3+ years in Medical Writing or supporting medical writing processes.

Strong understanding of CSR, ICF, Protocols, IBs, and related clinical documents.

Familiarity with clinical data sources, statistical outputs, and cross-functional touchpoints.

Proven experience gathering requirements, writing specifications, and working as a Business Analyst.

Excellent communication, analytical, and documentation skills.

Ability to coordinate across teams and translate technical concepts into business language.

📩 Interested candidates can share their resume at:

vishal.raj@therxcloud.com