Novartis is Hiring Senior Medical Writer II

Novartis is Hiring Senior Medical Writer II

24 November, 2022

Novartis is Hiring Senior Medical Writer II

Job Purpose:

To write, review and manage the preparation of high quality clinical documents for CPO’s and global organization. Provide authoritative documentation related consultancy to other line functions.

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but are not limited to:

  • To author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF).
  • To write CTD modules and other safety documents (DSURs, RMPs) independently. Liaise with medical/clinical experts, statisticians, investigators in concept development when protocol is being developed and work in a collaborative fashion for global/CPOs
  • Contribute to planning of data analyses and presentation to be used in CSRs
  • Ensure compliance of documentation to internal company standards and external regulatory guidelines.
  • Act as project medical writer for various programs in CPOs/global organization and ensure medical writing resource allocation to studies within these programs.
  • Supervise outsourcing to external medical writers, if necessary in conjunction with mentoring medical writer. Follow and track clinical trial milestones and resource requirements for assigned projects
  • Training and mentoring of associates as required. Contribute to cross-functional communication to optimize feedback and input towards high quality documents.
  • Maintain audit, SOP and training compliance.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

WHAT YOU’LL BRING TO THE ROLE:

  • Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
  • ≥ 4 years of regulatory medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.
  • Excellent communication skills (written, verbal, presentations)
  • Strong operational knowledge of clinical trial reporting.
  • Strong knowledge of biostatistics principles.
  • Strong ability to prioritize and manage multiple demands and projects.
  • Strong knowledge of /experience in submission documents. Strong knowledge of and experience in global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements).
  • Broad knowledge and future oriented perspective

Apply Online

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