Lead - Scientific Writing at Global Healthcare Company, Bangalore (On-site)
Job Summary
A leading healthcare solutions provider is seeking a Lead – Scientific Writing professional in Bangalore. The role demands 10–12 years of experience in clinical and regulatory writing, especially in preparing CTD Module 2 and Module 5 documents. This is an excellent opportunity for seasoned writers with strong leadership abilities to manage complex writing projects and mentor junior medical writers in a dynamic, global environment.
Key Responsibilities
Author and review diverse regulatory and clinical documents such as CSRs, Protocols, IBs, CTD Module 2 summaries, ICFs and amendments.
Lead cross-functional teams to draft high-quality scientific/medical content addressing data interpretation, product claims, and stakeholder queries.
Apply lean authoring principles and structured content management processes.
Develop, coordinate, and manage project and work plans ensuring timely document delivery.
Oversee document reviews, consensus meetings, quality checks, and finalizations under strict deadlines.
Manage and mentor a team of writers, including training, workload distribution, and performance monitoring.
Ensure adherence to regulatory requirements, standard content, templates, and sponsor-defined best practices.
Conduct literature reviews, stay updated with evolving global regulatory guidelines, and contribute to departmental improvement initiatives.
Required Skills & Qualifications
Education: MBBS, PhD, MDS, BDS, MPharm, or PharmD.
Experience: 10 to 12 years in clinical and regulatory writing supporting global filings.
Expertise in CTD Modules 2.4, 2.5, 2.6, 2.7, 5.2, CSRs, protocols, IBs, ICFs.
Strong understanding of clinical development processes and regulatory pathways (EU, US).
Excellent command of MS Word, document management systems, and document workflows.
Proven ability to develop, coordinate, and deliver work plans for document teams.
Experience with structured content libraries and lean authoring techniques.
Strong leadership and people management skills with 2+ years of team oversight.
Exceptional organizational, communication, and interpersonal skills.
Ability to manage messaging consistency across multiple therapeutic areas.
Familiarity with regulatory writing best practices, including FDA and EMA guidelines.
Perks & Benefits
Opportunity to work with a global leader in healthcare and regulatory solutions.
Leadership role with team management and training responsibilities.
Exposure to cross-functional projects and diverse therapeutic areas.
Fast-paced, collaborative, and growth-oriented work environment.
Continuous learning through workshops, training programs, and conferences.
Company Description
This globally recognized healthcare and pharmaceutical solutions provider specializes in regulatory writing, clinical research, and medical communications, offering innovative services to leading pharmaceutical organizations worldwide.
Work Mode
On-site (Bangalore, India)
Call-to-Action
Are you ready to lead regulatory writing projects on a global scale? Apply now to become the Lead - Scientific Writing and contribute to shaping future healthcare innovations.
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