Drug Substance Project Manager (E2e)

5-10 years

Not Disclosed

Hyderabad

10 March 6, 2025

Job Description

Job Type: Full Time Education: MBA/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Drug Substance Project Manager (E2E)
Company: Novartis Healthcare Private Limited
Location: Hyderabad (Office), India
Job Type: Full-Time, Regular
Division: Operations
Business Unit: Innovative Medicines
Functional Area: Technical Operations
Job ID: REQ-10041461

Summary:

The Drug Substance Project Manager (E2E) is responsible for leading, planning, and organizing project activities for lifecycle changes at established external API supply points. This role supports and drives the strategic objectives of the overall program.

Key Responsibilities:

Accountable for planning and delivering the project and activities in alignment with organizational goals.
Develop and implement long-term goals, milestone planning, and key objectives to ensure project success.
Ensure project activities adhere to organizational policies, relevant legislation, and professional standards.
Develop necessary forms and records for proper documentation of project activities.
Collaborate with key stakeholders to define and establish project goals and plans.
Work closely with program managers to track progress and provide updates on strategy or priority changes.
Drive project communication, stakeholder management, and cross-functional facilitation for alignment and buy-in.
Report to the Program Manager on individual project progress within the overall program.
Identify and evaluate project risks, taking appropriate action to mitigate them.
Define and execute corrective actions where necessary.
Support Life Cycle Process Improvement Initiatives.
Ensure GMP and regulatory compliance (including record management) and drive continuous quality improvements.
Orchestrate project teams contributing to project success.

Essential Requirements:

5-10 years of experience in a similar role.
Strong leadership skills, including decision-making, result orientation, negotiation, stakeholder management, and capability to challenge/support others.
In-depth knowledge of Supply Chain Lifecycle Management (LCM) processes.
Experience in Supply Chain Management within the Pharmaceutical Industry.
Extensive Project Management expertise.
Intercultural experience and ability to navigate a complex and rapidly changing business environment.
Basic understanding of cGxP regulations.

Desirable Requirements:

Degree in Science or Business Administration.

Why Novartis?

Helping people with diseases and their families takes more than innovative science. It takes a community of smart, passionate people collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives.

Learn more: Novartis Careers

Join Our Novartis Network:

If this role isn’t the right fit for you, sign up to our talent community to receive notifications about suitable career opportunities: Join Here

Benefits and Rewards:

Check out our handbook to discover how Novartis supports your personal and professional growth: Read More

Accessibility and Accommodation:

Novartis is committed to providing reasonable accommodations for individuals with disabilities. If you require accommodation during the recruitment process or to perform essential job functions, please contact diversityandincl.india@novartis.com with the job requisition number REQ-10041461.

Novartis fosters an inclusive and diverse work environment, ensuring representation of the patients and communities we serve.

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