Job Title: Associate Manager – Scientific Writing
đź“… Date: 23 Aug 2025
đź“Ť Location: Bangalore, KA, IN
Education
MBBS / PhD / MDS / BDS / MPharm / PharmD
Experience
10–12 years in authoring Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5)
Minimum 2 years of people management experience
Role Purpose
Responsible for managing complex Medical Writing (MW) projects, providing review support for regulatory deliverables, training junior writers, and ensuring high-quality submissions for global filings.
Key Skills
Medical Writing Expertise
Authoring a wide range of clinical/regulatory documents:
CTD Modules: 2.4, 2.5, 2.6, 2.7, 5.2
Clinical Study Reports (CSRs)
Protocols & Amendments
Informed Consent Forms (ICFs) & Amendments
Investigator Brochures (IBs)
Strong ability in focused/lean writing and editing using defined processes and templates
Skilled in managing cross-functional teams to align on data interpretation, product claims, and messaging
Knowledge & Scientific Understanding
Strong understanding of:
Clinical development process (from program planning to submission)
Regulatory guidelines (FDA, EMA, ICH, EU, US regional guidelines)
Therapeutic area science, medical practices, medications, and treatments
Ability to:
Interpret complex clinical data
Develop logical clinical/regulatory arguments
Ensure consistency in messaging and documentation strategy
Technology & Tools
Expert in MS Word and advanced formatting functions
Experience with document management systems, workflows, and e-approval/signature systems
Skilled in using Word add-ins for managing references, styles, and templates
Flexible in adapting to new tools and able to train team members
Soft Skills
Excellent verbal & written communication
Strong organizational, time management, and interpersonal skills
Customer focus and problem-solving mindset
Team leadership and people management
Responsibilities
Document Authoring & Review
Independently prepare/review:
Clinical study reports (CSRs)
Protocols & amendments
Investigator brochures (IBs)
Submission documents (Module 2 summaries)
Other regulatory documents for investigational drugs
Apply lean authoring principles and use structured content management text libraries
Conduct literature searches, screening, and reference checks as needed
Project & Team Management
Develop, maintain, and oversee project/work plans (timelines, roles, responsibilities)
Lead document kick-off, review, consensus, and QC meetings under tight timelines
Ensure adherence to best practices, templates, and lean writing standards
Manage and mentor junior writers, including training and performance development
Represent Medical Writing on cross-functional teams
Compliance & Quality
Ensure regulatory and quality standards compliance
Maintain inspection readiness documentation
Research and stay current on regulatory requirements
Share best practices and lessons learned within the team
Ensure completion of company training and accurate time reporting
Collaboration
Drive effective communication between writers and cross-functional stakeholders
Facilitate review meetings, address feedback, and negotiate solutions
Contribute to departmental initiatives and continuous improvement efforts
Desired Profile
Must-Have
Attention to detail
Critical thinking and analytical ability
Strong comprehension & communication skills
Proven ability to manage multiple projects under pressure
Nice-to-Have
Advanced certificate/training in Medical Writing or Regulatory Affairs
Prior experience across multiple therapeutic areas
âś… Impact: You will play a critical role in ensuring timely, high-quality clinical and regulatory document submissions that enable successful global filings.
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