Medical Director Ii

7+ years

Not Disclosed

Hyderabad

10 Dec. 18, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Medical Director II
Location: Hyderabad, India
Job ID: REQ-10029780
Date: Dec 16, 2024

Job Summary:

The Medical Director II will oversee the planning, execution, and interpretation of clinical trials, including data collection and clinical operations. This role is crucial for establishing scientific methods for clinical protocol design, data collection systems, and final reports. The Medical Director II will support ongoing clinical research and ensure timely processing of clinical and confidentiality agreements.

Major Accountabilities:

Clinical Leadership: Provide strategic guidance for all clinical deliverables within the assigned clinical program(s), ensuring alignment with global strategies.
Regulatory Documents: Lead the development of clinical sections in trial and program-level regulatory documents.
Collaboration: Collaborate with global line functions to drive the execution of clinical programs and ensure effective cross-functional communication.
Medical Expertise: Serve as the medical expert, engaging with external stakeholders such as regulatory authorities, key opinion leaders, and advisory boards. Provide medical input into Integrated Development Plans (IDP) and Clinical Trial Plans (CTP).
Stakeholder Engagement: Contribute to medical/scientific training for relevant Novartis stakeholders and serve as a speaker for franchise medical/scientific training sessions.
Leadership & Training: Lead or contribute to global initiatives such as process improvement, SOP development, and training. Mentor and develop high-potential talents for future leadership roles.
Compliance & Reporting: Ensure timely reporting of adverse events and special case scenarios as per Novartis policies. Comply with all regulatory requirements and internal standards.

Key Performance Indicators:

Achievement of unit objectives and timely delivery of clinical trials.
Adherence to quality standards, Novartis policies, and external regulations.
Effective collaboration and stakeholder engagement across teams.

Minimum Requirements:

Work Experience:

Experience in strategy development, project management, and cross-functional collaboration.
Expertise in operations management and execution in a clinical research environment.
Experience in representing the organization in external engagements.

Skills:

Strong background in clinical trials, data analysis, data monitoring, and drug development.
Medical research expertise with a focus on medical strategy and clinical trial management.
People management skills, with the ability to lead teams and foster talent development.

Languages:

Proficiency in English (oral and written).

Why Novartis?

Novartis is committed to creating a brighter future for patients through innovative science. The company fosters a collaborative environment where passionate individuals work together to achieve breakthroughs. Join Novartis to be part of a community dedicated to improving lives.

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Medical Director Ii

Job Description

Job Summary:

Major Accountabilities:

Key Performance Indicators:

Minimum Requirements:

Work Experience:

Skills:

Languages:

Why Novartis?

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