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GSK India
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Manager Content Quality Strategy

Manager Content Quality Strategy

GSK India

10 - 15 years

15 - 20 Lacs

bengaluru

Posted:1 day ago| Platform:

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Skills Required

procurement cro automation project management pharma pharmacy workflow life sciences forecasting capacity planning

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Manager Content Quality Strategy will play a pivotal role in driving scientific content integrity, process excellence, and capability enhancement within the Medical Writing organization. This role is responsible for establishing strategic quality frameworks, optimizing workflows, and leading capability-building initiatives to ensure medical writing deliverables meet global standards of accuracy, compliance, and scientific credibility.

Key Responsibilities:

Strategic Quality Leadership:
- Implement content QC strategy across the clinical documentation portfolio.
- Embed a quality-by-design mindset into workflows, ensuring proactive risk mitigation and first-time-right delivery of documents.
- Align new ways of working / QC governance with global SOPs, GPP, and ICH E3/E6 standards.
Process and Workflow Optimization:
- Evaluate existing processes to identify efficiency gaps and redundancies.
- Design and implement standardized QC workflows, checklists, and templates across clinical documents.
- Implement tools, dashboards, and automation solutions to enhance content delivery.
Capability Building:
- Develop and lead training programs focused on content QC, lean authoring standards, and compliance adapting to acceleration objectives.
- Create capability framework to ensure consistent performance and quality.
- Lead audits and quality monitoring to come up with RCA and CAPA, as needed.
Stakeholder & Project Management:
- Collaborate with global medical writing leads, asset leads, and cross-functional stakeholders.
- Manage capacity planning, resource allocation, and workload forecasting for FTEs and FSPs.
- Manage metrics and quality KPI reporting.
Innovation & Strategic Contribution:
- Drive process innovations to enhance content quality strategy and delivery.
- Act as a change agent for continuous improvement within the global Medical Writing organization.

Education Requirements (minimum expected):

Master s degree or higher in Life Sciences / Pharmacy / Biomedical Sciences.

Job Related Experience (minimum requirements):

Master s degree or higher in Life Sciences / Pharmacy / Biomedical Sciences.
10+ years of experience in Medical Writing and QC within pharma or CRO environment, including 3 5 years in a process, quality, or technical leadership role.
Proven expertise in clinical documents (CSR, IB, protocols, ICFs, RMPs, and regulatory submissions).
Strong understanding of regulatory guidelines (ICH E3, E6, GPP, EMA, FDA).
Strong communication, strategic thinking, and stakeholder management skills.
Knowledge of emerging technologies and industry trends to drive innovation.

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GSK India

Pharmaceuticals & Biotechnology

Mumbai

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Manager Content Quality Strategy