Job Description

Summary To write, review and manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative documentation-related consultancy to other line functions. To coach, mentor and train less experienced writers.

Major accountabilities:

• To author, review and/or independently manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Risk Management Plans (RMP), complex CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e.g., Briefing Books, answers to questions).
• Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
• Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions.
• Documentation expert in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines.
• Provide content and strategic expertise for clinical portions of the CTD.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards -Customer / partner/ project feedback and satisfaction -Adherence to Novartis policy and guidelines

Minimum Requirements:
Work Experience:

• Functional Breadth.
• Project Management.
• Collaborating across boundaries.
• Operations Management and Execution.
• Representing the organization.

Skills:

• Clinical Research.
• Clinical Trials.
• Detail Oriented.
• Medical Writing.
• People Management.
• Project Management.
• Regulatory Compliance.
• Safety.

Languages :

• English.

Skills Desired Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, People Management, Regulatory Compliance, Safety, Waterfall Model