Manager - Scientific Writing (DDH Regulatory) GSC
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-80245
Purpose:
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.
Primary Responsibilities:
Portfolio Management/Delivery:
Manage and deliver the overall book of work for the assigned area (DDH Regulatory).
Develop and execute sourcing plans in partnership with GSC leads to ensure seamless delivery of asset plans and priorities.
Collaborate with function, capability, and site leadership to align business planning and operations.
Coordinate across therapeutic areas, phases of development, and geographies to develop synergies.
Adjust work plans based on shifting priorities using effective change control.
Lead and direct internal and external team members to achieve team goals.
Identify and resolve issues impacting delivery of work.
Implement new and efficient ways to accomplish goals.
Manage vendor selection and relationships.
Report team activities and metrics to leadership and stakeholders.
Ensure audit readiness, quality, and compliance with internal/external guidance and regulations.
People Management and Development:
Recruit, develop, and retain a strategic workforce skilled in scientific communications.
Create and manage an agile organization that meets changing portfolio needs.
Build an organizational culture aligned with Team Lilly values.
Develop staff with expertise in drug development, therapeutic area science, and project management.
Provide input on employee development, talent assessment, and succession planning.
Guide, train, and supervise personnel.
Manage workload, monitor project timelines, and communicate priorities.
Provide technical support and evaluate performance, recommending developmental actions.
Ensure compliance with company policies and regulations.
Document Preparation, Development, and Finalization:
Develop scientific content for deliverables as needed.
Subject Matter Expert/Organizational Effectiveness:
Lead the development of new capabilities to support GSC effectiveness.
Act as an expert on document strategy, planning, execution, and industry standards.
Develop, implement, and update Lilly policies, procedures, training, and tools compliant with industry guidelines.
Minimum Qualification Requirements:
Master’s degree in a scientific, health, communications, technology, health outcomes, or public health-related field.
6-8 years of experience in medical communication/pharmaceutical industry.
2-3 years of experience leading/managing a key part of a portfolio or business process.
2-3 years of experience in leading others, including relationship building, setting expectations, and providing technical coaching.
Strong scientific communication skills, including experience in writing, reviewing, and publishing scientific materials.
Ability to critically appraise scientific literature and raw data.
Successful completion of writing exercise.
Other Information/Additional Preferences:
Advanced degree (MBBS, MD, PharmD, PhD, MPH).
Background in healthcare, medical affairs, clinical development, or scientific communications.
Expertise in industry standards, compliance issues, and regulatory requirements.
Strong leadership, problem-solving, negotiation, and project management skills.
Knowledge of clinical pharmacology, therapeutic areas, and research principles.
Experience managing business plans, budgeting, and capacity resourcing.
Experience leading submission or launch activities.
Knowledge of software/tools used in scientific writing.
Limited international travel up to 10%.
Lilly is dedicated to ensuring equal opportunities and providing accommodations during the application process.
#WeAreLilly
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