Regulatory Writer – Medical Writing
Location; Bangalore, Karnataka, India
Category; Research & Development
Job Type; Full-time Regular
Job; Id R-44031
Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.
The purpose of the Scientific Communications Associate – Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications).
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements when it was prepared. The job requirements of any position may change over time and include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your job responsibilities and any related duties that may be required for the position.
1. Content Strategy and Execution: Document Preparation, Development, and Finalization/Document Management
- Collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.
- Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.
- Conduct effective document initiation meetings to ensure authoring team alignment and understanding.
- Build a scientific-based rationale that supports the purpose of more complex and/or strategic documents.
- Ensure data are presented in a clear, complete, accurate, and concise manner.
- Ensure that key data, statements, and conclusions are consistent across related documents and that statements and conclusions are integrated, accurate, balanced, and supported by appropriate data.
- Coordinate expert/scientific reviews, collate reviewer comments, adjust the document’s content based on internal/external input, and prepare the final version.
- Ensure and coordinate quality checks for accuracy.
- Exhibit flexibility in moving across development and preparation of multiple document types.
- Influence or negotiate a change of timelines and content with other team members.
- Work with internal and external experts to develop and prepare presentations.
- As needed, may build and manage relationships with vendors/alliance partners.
2. Project and Stakeholder management
- Lead the writing process and apply effective project management skills to ensure the timely completion of high-quality regulatory documents.
- Build/communicate credible writing project timelines.
- Anticipate and mitigate risks to delivery.
- Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.
- Effectively communicate project status to stakeholders.
3. Knowledge and Skills Development
- Maintain and enhance therapeutic area knowledge, including disease state and compound(s) for assigned project(s).
- Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment.
- Maintain and enhance knowledge of regulatory guidelines and publication guidelines.
- Possess an overarching view of the compound, therapeutic area, and external environment (including competitors) with the ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.
- Maintain and enhance scientific communications skills to align with the audience’s needs and changes in technology and platforms.
4. Knowledge Sharing
- Provide coaching to others by sharing technical information, giving guidance, and answering questions.
- She is recognized for technical expertise in specific document development.
- Network with others (including other functions and regions) to identify and share best practices.
- Contribute to process improvements, suggesting opportunities where appropriate.
- Provide database and other tools (e.g., document management systems) expertise.
Minimum Qualification Requirements
- Bachelor’s degree in a scientific, health, communications, technology health-related field.
- Demonstrated experience in technical/ regulatory scientific writing.
- Strong communication and interpersonal skills.
- Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)
Other Information/Additional Preferences
- Graduate degree with a formal research component or in life sciences.
- Demonstrated mastery of verbal and written English skills in the medical, scientific, or technical writing fields.
- Clinical pharmacology, therapeutic area, or other medical and scientific-specific knowledge and experience specific to the hiring area (e.g., neuroscience, oncology, cardiovascular, immunology, or endocrine expertise).
- Experience writing regulatory, clinical trial documents and/or publications
- Experience in clinical development, clinical trial process, or regulatory activities.
- Demonstrated project management and time management skills.
- Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations, and templates).
Eli Lilly and Company, Lilly USA, LLC, and our wholly owned subsidiaries (collectively “Lilly”) are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request accommodation as part of the application process. Any other correspondence will not receive a response.
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