Job Summary
Syneos Health is hiring a Lead – Scientific Writing professional for its Bangalore location. This pivotal role involves handling complex medical writing projects, leading the preparation and review of regulatory documents supporting global filings, and managing junior writers. The ideal candidate will bring 10 to 12 years of experience in clinical and regulatory writing, particularly CTD Module 2 and 5 documents, and possess strong leadership and cross-functional collaboration skills to drive high-quality deliverables aligned with global regulatory standards.
Key Responsibilities
Independently prepare and review CSRs, protocols, Investigator Brochures, and submission documents (CTD Module 2 summaries).
Apply lean authoring principles and manage structured content libraries for efficient document development.
Lead and coordinate document review meetings, consensus discussions, and ensure quality control.
Develop and maintain comprehensive project and team work plans, ensuring adherence to timelines.
Provide people management, coaching, and mentorship to junior writing staff.
Represent Medical Writing in cross-functional teams and ensure communication flow among stakeholders.
Conduct literature searches, monitor regulatory guidelines, and integrate best practices into deliverables.
Oversee document workflows, manage version control, and ensure finalization within aggressive timelines.
Support departmental initiatives and continuous process improvement activities.
Required Skills & Qualifications
Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
Experience: 10–12 years in medical writing, regulatory document development for CTD Module 2 & 5
Proven expertise in authoring CSRs, IBs, protocols, amendments, and clinical summaries
Strong understanding of global regulatory guidelines (FDA, EMA)
Exceptional leadership and people management abilities (minimum 2 years)
Expertise in MS Word and document management systems (e.g., eApproval/signature workflows)
Familiarity with Word add-ins and template tools
Ability to provide training and process guidance to other writers
Effective communication, organizational, and time management skills
Strong scientific reasoning and ability to build logical regulatory arguments
Perks & Benefits
Lead high-visibility global regulatory writing projects
Career growth opportunities in scientific leadership
Work in a collaborative and innovation-driven environment
Access to professional development and training programs
Competitive compensation and benefits package
Company Description
Syneos Health is a leading biopharmaceutical solutions company offering end-to-end services in clinical development, medical writing, and regulatory affairs. Our expertise supports top pharmaceutical companies in bringing new therapies to market faster and more efficiently.
Work Mode
On-site – Bangalore, Karnataka, India
Call to Action
Are you an experienced scientific writing leader ready to shape the future of regulatory submissions? Apply now to join Syneos Health and contribute to global healthcare innovations!
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