At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Purpose:
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 at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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.

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).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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Please refer the Job description for details