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Scientific Writer Ii

2+ years
Not Disclosed
10 Jan. 7, 2025
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

Position: Scientific Writer II
Location: Hyderabad, India (Hybrid)

About the Role:
The Scientific Writer II will be responsible for writing and editing high-quality clinical and safety documents under guidance. These include non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents, and Patient Narratives.

Key Responsibilities:

  • Write and/or edit high-quality clinical and safety documents under guidance, ensuring compliance with internal company standards and external regulatory guidelines.
  • Act as a documentation consultant in Clinical Trial Teams (CTTs) and ensure adherence to documentation requirements.
  • Collaborate with CTTs and publishing teams to ensure timely document delivery for publishing.
  • Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours.
  • Distribute marketing samples (when applicable).
  • Ensure timely preparation of publications to meet regulatory requirements and support marketing activities.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams that represent the patients and communities we serve.

Essential Requirements:

  • Minimum: Life-science degree (e.g., B.Sc./equivalent) with 4 years of Clinical Research experience, or M.Sc./M.Pharm with 2 years of experience.
  • Desired: Doctoral degree or Medical Sciences qualification (MBBS/MD) with 1 year of Clinical Research experience.
  • Excellent written and oral communication skills in English.
  • Ability to work independently, prioritize tasks, and handle multiple projects.

Why Novartis:
Novartis is dedicated to reimagining medicine to improve and extend lives. Our success lies in our people, who drive our mission each day. Learn more about our vision and culture at Novartis Strategy.

You’ll Receive:
Find more details about our benefits and rewards in the Novartis Life Handbook.

Join Our Novartis Network:
If this role doesn’t match your experience or career goals, join the Novartis Network to stay updated on future opportunities: Novartis Talent Network.

Benefits and Rewards:
Read about how we help our associates thrive in both their personal and professional lives in our Benefits Handbook.

Division: Operations
Business Unit: Innovative Medicines
Location: Hyderabad, India
Company/Legal Entity: Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time, Regular
Shift Work: No