Regulatory Writer

Freshers years

3 LPA to 5 LPA

Bengaluru

15 July 19, 2024

Job Description

Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Writer

Location: Bangalore, Karnataka, India

Category: Research & Development

Job Type: Full Time, Regular

Job ID: R-64526

Company Overview:

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:

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. These documents include, but are not limited to, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications.

Primary Responsibilities:

Content Strategy and Execution:

Document Preparation, Development, and Finalization/Document Management
Collect and evaluate data from multiple sources to create a cohesive content strategy for writing projects.
Plan, write, edit, review, coordinate, and complete regulatory documents supporting clinical development/product registration.
Conduct document initiation meetings to ensure team alignment.
Build scientific rationale for complex documents.
Ensure data is presented clearly, accurately, and concisely.
Maintain consistency across related documents.
Coordinate expert reviews, collate comments, adjust content, and prepare final versions.
Perform quality checks for accuracy.
Exhibit flexibility across multiple document types.
Influence or negotiate changes to timelines and content.
Work with experts to develop presentations.
Manage relationships with vendors/alliance partners.

Project and Stakeholder Management:

Lead the writing process and apply project management skills.
Build and communicate writing project timelines.
Anticipate and mitigate risks to delivery.
Ensure smooth and timely development of documents.
Communicate project status to stakeholders.

Knowledge and Skills Development:

Maintain and enhance therapeutic area knowledge.
Exhibit flexibility across document types, therapeutic areas, and compounds.
Maintain knowledge of regulatory and publication guidelines.
Participate in clinical planning and submission strategy planning.
Maintain and enhance scientific communication skills.

Knowledge Sharing:

Provide coaching and share technical information.
Recognized for technical expertise in document development.
Network with others to identify and share best practices.
Contribute to process improvements.
Provide expertise in database and document management systems.

Minimum Qualification Requirements:

Bachelor’s degree in a scientific, health, communications, or technology-related field.
Demonstrated experience in technical/regulatory scientific writing.
Strong communication and interpersonal skills.
Successful completion of a writing exercise (required as part of the candidate evaluation process).

Additional Preferences:

Graduate degree with formal research component or in life sciences.
Mastery of verbal and written English skills in medical, scientific, or technical writing fields.
Knowledge and experience in clinical pharmacology, therapeutic areas, or other medical and scientific fields specific to hiring areas (e.g., neuroscience, oncology, cardiovascular, immunology, or endocrine expertise).
Experience writing regulatory, clinical trial documents, and/or publications.
Experience in clinical development, clinical trial processes, or regulatory activities.
Project management and time management skills.
High-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).

Equal Opportunity:

Eli Lilly and Company, Lilly USA, LLC, and our wholly owned subsidiaries (collectively “Lilly”) are committed to helping individuals with disabilities participate in the workforce and ensuring equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources at Lilly_Recruiting_Compliance@lists.lilly.com for further assistance. This email address is intended for use only to request an accommodation as part of the application process. 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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Regulatory Writer

Job Description

Job Title: Regulatory Writer

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