Great opportunity as Senior Medical Writer @ Novartis

Novartis

Website Novartis

About Novartis

Novartis boasts one of the most captivating product pipelines within the industry at present. This assembly of inventive medications comes to fruition through a spectrum of skilled, motivated, and high-achieving individuals. This collective effort positions them as one of the most fulfilling employers in their sector.

Post:

Senior Medical Writer II

Job Description:

  • Authoring, reviewing, and independently managing high-quality clinical documents: Clinical Study Reports (CSR), Protocols, Informed Consent Forms (ICF).
  • Writing CTD modules and other safety documents (DSURs, RMPs) independently, collaborating with medical/clinical experts, statisticians, and investigators during protocol development.
  • Contributing to data analysis planning and presentation for CSRs.
  • Ensuring documentation compliance with internal standards and regulatory guidelines.
  • Acting as project medical writer for CPOs/global programs, allocating resources to studies within these programs.
  • Supervising outsourcing to external medical writers if needed, alongside mentoring.
  • Tracking clinical trial milestones and resource needs for assigned projects.
  • Training and mentoring associates as necessary.
  • Cross-functional communication to optimize document quality.
  • Maintaining audit, SOP, and training compliance.

Candidate Profile:

  • Minimum science degree or equivalent (B.Sc./equivalent) with 10 years of Clinical Research (CR) experience.
  • M.Sc./M.Pharma +8 years of clinical research (CR) experience.
  • Excellent written and oral English skills.
  • Desired: Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent) PhD + 6 years of CR experience, MBBS/equivalent + 6 years of CR experience.

Additional Information:

  • Experience: 5+ years
  • Qualification: M.Sc./ M.Pharma
  • Location: Hyderabad, AP
  • Industry Type: Pharma / Healthcare / Clinical Research
  • Functional Area: Research & Development
  • End Date: 10th September 2023

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