Senior Associate/Lead Global Scientific Communications (GSC) Regulatory Writing

📌 Core Information

🔹 Job Title: Senior Associate/Lead Global Scientific Communications (GSC) Regulatory Writing

🔹 Company: Eli Lilly and Company

🔹 Location: Bangalore, Karnātaka, India

🔹 Job Type: Full-Time

🔹 Category: Pharmaceuticals

🔹 Date Posted: May 2, 2025

🔹 Experience Level: Mid-Senior level (5-10 years)

🔹 Remote Status: On-site

🚀 Job Overview

Key aspects of this role include:

• Leading the writing process for regulatory documents
• Applying effective project management skills
• Collaborating with various stakeholders
• Maintaining and enhancing therapeutic area knowledge

ASSUMPTION: This role requires a high level of organization, communication, and scientific knowledge to manage complex writing projects and ensure timely delivery of high-quality documents.

📋 Key Responsibilities

✅ Content Strategy and Execution: Develop and finalize regulatory documents, coordinate expert reviews, ensure data accuracy, and manage document management systems.

✅ Project and Stakeholder Management: Lead writing projects, build project timelines, mitigate risks, and communicate project status to stakeholders.

✅ Knowledge and Skills Development: Maintain and enhance therapeutic area knowledge, regulatory guidelines, and scientific communication skills.

✅ Knowledge Sharing: Provide coaching to others, share technical information, and contribute to process improvements.

ASSUMPTION: This role involves a significant amount of cross-functional collaboration and requires strong project management skills to balance multiple projects and deadlines.

🎯 Required Qualifications

Education: Bachelor’s degree in a scientific, health, communications, technology, or health-related field.

Experience: Demonstrated experience in technical/regulatory scientific writing.

Required Skills:

• Strong communication and interpersonal skills
• Successful completion of a writing exercise

Preferred Skills:

• 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
• 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

ASSUMPTION: While a Bachelor's degree is the minimum requirement, candidates with a graduate degree and relevant experience in the pharmaceutical industry will have a competitive advantage.

💰 Compensation & Benefits

Salary Range: INR 15,00,000 - 20,00,000 per annum (Estimated, based on industry standards for mid-senior level roles in the pharmaceutical industry in Bangalore)

Benefits:

• Health insurance
• Retirement benefits
• Employee assistance programs
• Tuition assistance
• Employee discounts

Working Hours: Full-time, typically Monday to Friday, 9:00 AM to 6:00 PM IST, with flexibility for project demands

ASSUMPTION: The salary range is estimated based on industry standards and may vary depending on the candidate's experience and negotiation skills.

📌 Applicant Insights

🔍 Company Context

Industry: Eli Lilly and Company is a global pharmaceutical corporation focused on discovering and developing life-changing medicines for people around the world. The company operates in the competitive pharmaceutical manufacturing industry.

Company Size: Eli Lilly and Company has over 10,000 employees worldwide, providing ample opportunities for collaboration and growth.

Founded: Eli Lilly and Company was founded in 1876 by Colonel Eli Lilly and is headquartered in Indianapolis, Indiana, USA.

Company Description:

• Eli Lilly and Company is committed to uniting caring with discovery to make life better for people around the world.
• The company focuses on improving the understanding and management of disease, as well as giving back to communities through philanthropy and volunteerism.
• Eli Lilly and Company fosters a culture where employees give their best effort to their work and put people first.

Company Specialties:

• Pharmaceutical development
• Pharmaceuticals
• Biotech and biopharmaceuticals

Company Website: www.lilly.com

ASSUMPTION: Eli Lilly and Company is a well-established pharmaceutical corporation with a strong global presence and a commitment to improving the lives of patients worldwide.

📊 Role Analysis

Career Level: This role is a mid-senior level position, requiring a significant amount of experience in regulatory scientific writing and project management.

Reporting Structure: The Senior Associate/Lead Global Scientific Communications (GSC) Regulatory Writing role reports directly to the Global Scientific Communications (GSC) team and works closely with various stakeholders, including clinical development teams, regulatory affairs, and medical affairs.

Work Arrangement: This role is on-site, with a flexible work arrangement that may require occasional overtime to meet project deadlines.

Growth Opportunities:

• Progression to a leadership role within the Global Scientific Communications (GSC) team
• Expansion of responsibilities to include mentoring and coaching junior team members
• Opportunities to work on high-impact projects and collaborate with cross-functional teams

ASSUMPTION: This role offers significant opportunities for professional growth and development within the Global Scientific Communications (GSC) team and the broader organization.

🌍 Location & Work Environment

Office Type: Eli Lilly and Company's Bangalore office is a modern, collaborative workspace designed to facilitate productivity and innovation.

Office Location(s): Eli Lilly and Company's Bangalore office is located in the LCCI (Lilly Corporate Center India) in Bangalore, Karnataka, India.

Geographic Context:

• Bangalore is the capital of the Indian state of Karnataka and is known as the "Silicon Valley of India" due to its thriving tech industry.
• The city offers a mix of traditional Indian culture and modern amenities, providing a unique living experience.
• Bangalore has a tropical savanna climate, with warm and humid weather throughout the year.

Work Schedule: The work schedule is typically Monday to Friday, 9:00 AM to 6:00 PM IST, with flexibility for project demands and occasional overtime.

ASSUMPTION: The Bangalore office provides a dynamic and collaborative work environment that fosters innovation and productivity.

💼 Interview & Application Insights

Typical Process:

• Online application submission
• Phone or video screening
• Writing exercise and presentation
• Final round interviews with key stakeholders

Key Assessment Areas:

• Writing and communication skills
• Project management skills
• Scientific knowledge and understanding
• Cultural fit and alignment with company values

Application Tips:

• Tailor your resume and cover letter to highlight your relevant experience and skills for this role
• Prepare for the writing exercise by reviewing regulatory writing guidelines and practicing your writing skills
• Research Eli Lilly and Company's mission, values, and recent projects to demonstrate your enthusiasm and alignment with the organization

ATS Keywords: Regulatory Writing, Project Management, Technical Writing, Communication Skills, Interpersonal Skills, Document Management, Clinical Development, Therapeutic Area Knowledge, Scientific Communication, Data Evaluation, Quality Checks, Coaching, Process Improvement, Computer Skills, Presentation Skills, Risk Mitigation

ASSUMPTION: The application process for this role is competitive, and candidates should be prepared to demonstrate their strong writing, project management, and scientific communication skills throughout the interview process.

🛠️ Tools & Technologies

• Microsoft Office Suite (Word, Excel, PowerPoint)
• Document management systems (e.g., Veeva Vault)
• Project management tools (e.g., Microsoft Project, Asana)
• Regulatory writing guidelines and templates

ASSUMPTION: Familiarity with industry-standard tools and technologies is essential for success in this role.

👔 Cultural Fit Considerations

Company Values:

• Integrity
• Excellent
• Patient-centered
• Inclusive
• Collaborative
• Curious

Work Style:

• Collaborative and team-oriented
• Results-driven and focused on delivering high-quality work
• Adaptable and able to manage multiple projects and deadlines

Self-Assessment Questions:

• Do you have a strong commitment to integrity and ethical decision-making?
• Are you able to work effectively in a collaborative, team-oriented environment?
• Do you have a proven track record of delivering high-quality work under tight deadlines?

ASSUMPTION: Candidates who demonstrate a strong alignment with Eli Lilly and Company's values and work style will be well-suited to this role.

⚠️ Potential Challenges

• Managing multiple projects and deadlines simultaneously
• Working with cross-functional teams and stakeholders with varying priorities and expectations
• Keeping up with the latest regulatory guidelines and industry trends
• Adapting to changes in project scope or priorities

ASSUMPTION: This role presents unique challenges that require strong project management skills, adaptability, and a commitment to continuous learning and improvement.

📈 Similar Roles Comparison

• Compared to other regulatory writing roles, this position offers a higher level of responsibility and autonomy, with the opportunity to lead projects and mentor junior team members.
• In the competitive pharmaceutical industry, this role provides an opportunity to work on cutting-edge medicines and therapies that have the potential to improve the lives of patients worldwide.
• Career progression in this role may lead to leadership positions within the Global Scientific Communications (GSC) team or other functions within Eli Lilly and Company.

ASSUMPTION: This role offers unique opportunities for professional growth and development within the pharmaceutical industry.

📝 Sample Projects

• Developing a regulatory submission for a new drug application (NDA)
• Writing a clinical study report (CSR) for a Phase III clinical trial
• Creating a patient information leaflet (PIL) for a newly approved medication

ASSUMPTION: These sample projects illustrate the diverse range of regulatory writing tasks that candidates may encounter in this role.

❓ Key Questions to Ask During Interview

• Can you describe the typical timeline for a regulatory writing project from initiation to final submission?
• How does the Global Scientific Communications (GSC) team collaborate with other functions, such as clinical development and regulatory affairs?
• What opportunities are there for professional development and growth within the Global Scientific Communications (GSC) team and the broader organization?
• How does Eli Lilly and Company support work-life balance for employees in this role?
• What are the most challenging aspects of this role, and how can I best prepare to succeed in them?

ASSUMPTION: Asking thoughtful and insightful questions during the interview process demonstrates your interest in and understanding of the role and the organization.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through the following link: https://lilly.wd5.myworkdayjobs.com/LLY/job/India-Bengaluru/Senior-Associate-Lead-Global-Scientific-Communications--GSC--Regulatory-Writing_R-85854-1
• Tailor your resume and cover letter to highlight your relevant experience and skills for this role
• Prepare for the writing exercise by reviewing regulatory writing guidelines and practicing your writing skills
• Research Eli Lilly and Company's mission, values, and recent projects to demonstrate your enthusiasm and alignment with the organization
• Follow up with the hiring manager one week after submitting your application to express your continued interest in the role

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.