Lilly Regulatory Medical Writer (Associate/Senior Associate Manager) job vacancy

Lilly Regulatory Medical Writer (Associate/Senior Associate Manager) job vacancy

Regulatory Medical Writer (Associate/Senior Associate Manager)

Bangalore, Karnataka, India

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 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 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, presentation and templates).

1. Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management

• Effectively 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 meeting to ensure authoring team alignment and understanding.

• Build scientific-based rationale that support 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’s comments, adjust content of document as required based on internal/external input, and prepare final version.

• Ensure and coordinate quality checks for accuracy.

• Exhibit flexibility in moving across development and preparation of multiple document types.

• Influence or negotiate 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 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 overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.

• Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms.

4. Knowledge Sharing

• Provide coaching to others by sharing technical information, giving guidance, answering questions.

• 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 tool (e.g., document management systems) expertise.

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