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Manager-Scientific Writing (Ddh Regulatory) Gsc

3+ years
Not Disclosed
10 March 24, 2025
Job Description
Job Type: Full Time Education: PhD/MD/PharmD/MPH/MBBS 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

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.

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