Eli Lilly and Company Hiring Regulatory Writer in Bangalore

Eli Lilly and Company Regulatory Writer in Bangalore | Apply Now

Eli Lilly and Company, a global healthcare leader, is seeking a dedicated and experienced Regulatory Writer to join their team in Bangalore, Karnataka. This role is ideal for individuals with a Bachelor’s degree in scientific, health, communications, or technology fields and demonstrated experience in regulatory writing. If you are passionate about making a difference in healthcare through effective scientific communication, this opportunity is perfect for you.

About Eli Lilly and Company

Eli Lilly and Company, headquartered in Indianapolis, Indiana, is committed to uniting caring with discovery to make life better for people around the world. With a rich history of groundbreaking medical advancements, Lilly is at the forefront of the healthcare industry, providing life-changing medicines and solutions to patients globally.

Job Title: Regulatory Writer

Location: Bangalore, Karnataka, India

Category: Research & Development

Job Type: Full-Time

Job ID: R-64526

Job Description

Purpose:

The purpose of the Regulatory Writer role is to provide balanced, objective, and accurate information to regulators, healthcare professionals, payers, and patients. You will be a crucial part of the Scientific Communications team, ensuring the development of high-quality regulatory documents that support clinical development and product registration.

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.

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.

Qualifications:

Minimum Requirements:

• Bachelor’s degree in scientific, health, communications, or technology fields.
• Demonstrated experience in technical/regulatory scientific writing.
• Strong communication and interpersonal skills.
• Successful completion of a writing exercise.

Preferred Qualifications:

• Graduate degree with formal research components or in life sciences.
• Mastery of verbal and written English in medical, scientific, or technical writing fields.
• Experience in clinical pharmacology or other medical and scientific areas.
• Project management and time management skills.
• High-level end-user computer skills.

Additional Information:

• Eli Lilly and Company is committed to providing equal opportunities and accommodations for individuals with disabilities.
• The company does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Apply Now

If you are ready to contribute to a team dedicated to improving global healthcare, apply online at Eli Lilly Careers.