Manager – Clinical Solutions CoE | Hinjawadi, Pune | Full-Time
Requisition ID: 10459
Location: Hinjawadi, Pune
Employment Type: Full-Time
Department: Clinical Solutions Center of Excellence
A leading global life sciences organization is seeking a Manager – Clinical Solutions CoE to drive client engagement, requirements management, and advanced scientific documentation processes. This role is central to transforming regulatory and medical writing workflows through structured methodology, cross-functional collaboration, and GenAI-enabled efficiencies.
Key Responsibilities
Client Discovery, Scoping, and Business Requirements
Lead client-facing discussions with Medical Writing and Regulatory teams to define requirements for Clinical Study Report (CSR) authoring, including template standards, therapeutic area nuances, and acceptance criteria.
Translate client objectives such as submission strategy, review workflows, and risk expectations into detailed deliverables.
Define scope, negotiate timelines and costs, and manage change requests with complete documentation.
Establish clear “definition of done” for all CSR sections, covering scientific tone, numerical accuracy, alignment with ICH E3 guidelines, and quality benchmarks.
Maintain a dynamic Requirements and Assumptions log throughout the project lifecycle.
Translation of Business Requirements into Technical Execution
Convert scientific and regulatory requirements into actionable technical briefs for GenAI Engineers, including priority TLFs, required outputs, prompt constraints, writing style rules, and data traceability expectations.
Define validation and evaluation frameworks to ensure GenAI-generated outputs meet accuracy, completeness, fidelity, and numerical consistency standards.
Serve as Business Product Owner for Rapid CSR features, owning the backlog and prioritizing enhancements, iterations, and defect resolutions based on regulatory impact.
Lead structured review cycles involving internal QC, subject-matter expert review, and statistical review, ensuring complete closure of comments and alignment with regulatory requirements.
Required Skills and Qualifications
Advanced degree in Life Sciences, Pharmacy, or related disciplines.
8 to 12 years of proven experience in CSR authoring, regulatory writing, and scientific documentation.
Strong command of clinical research processes, regulatory guidelines, and ICH frameworks.
Working knowledge of GenAI/LLMs, including prompt engineering, evaluation methods, human-in-the-loop workflows, and versioning standards.
Proficiency in interpreting clinical data sources (protocols, SAPs, TLFs, patient narratives) and performing numerical consistency checks.
Demonstrated capability in planning, negotiation, client expectation management, and cross-functional stakeholder coordination.
Soft Skills and Cross-Functional Collaboration
Collaborate closely with diverse teams including clinical data engineers, data modelers, QA/CSV specialists, developers, clinical SMEs, project managers, and infrastructure teams to meet project goals.
Maintain comprehensive documentation covering methodologies, processes, and analytical outcomes.
Prepare and deliver detailed project reports and presentations for clients and internal leadership, showcasing the impact of data-driven and AI-assisted medical writing strategies.
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