Associate - Scientific Writing

**Date**:22 Aug 2025

**Location**:Bangalore, KA, IN
- Job Description-
- Must Have- EDUCATION: Life Science Degree- EXPERIENCE: Minimum 3 years of writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5)- ROLE PURPOSE: MW is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals
SKILLS:

- Experienced in authoring multiple clinical study reports (CSRs), protocols, amendments, and Investigator Brochures (IBs); experience in writing some clinical summary documents (Module 2.5, 2.7) preferred
- Demonstrated excellence in focused/lean writing and editing following defined processes and templates
- Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions
- Communication skills commensurate with a professional working environment
- Effective time management, organizational, and interpersonal skills
- Customer focus
- Comfortable following directions, templates, and structured processes for delivering documents for review and finalization
- Able to work independently while maintaining communication with the Sponsor’s MW project manager
- Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines
- Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion
- Adherence to processes and Sponsor-defined best practices
- Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements
- KNOWLEDGE REQUIREMENT:
- Scientific Knowledge
- Understanding of International Council on Harmonization (ICH) guidelines and other regional guidelines such as those from the European Union and United States
- Understanding of medical practices regarding procedures, medications, and treatment for different disease states
- Technology Skills
- Expert authoring in MS Word, understanding of MS Word functionality
- Experience working in document management systems; managing workflows through tools
- Experience working with MS Word add-ins that facilitate the management of fonts, styles, references, etc.
- Flexibility in adapting to new tools and technology
- Capable of training writers/authors on the use of templates, guidelines, and tools

Good to have- RESPONSIBILITIES:

- With mínimal guidance from senior members of writing staff prepare clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development using existing systems and processes
- Utilize concept of lean authoring in the authoring process
- Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines
- Coordinate and facilitate document kick-off meetings with writers and cross-functional representatives
- Ensure adherence to standard content, lean authoring, and messaging across team members
- Ensure communication channels remain open and information is disseminated appropriately
- Work as an active member of cross-functional teams
- Conduct appropriate literature searches and literature screening, when required
- Ensure compliance with company training and time reporting
- EQUAL OPPORTUNITY