Instagram
youtube
Facebook

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 #LI Hybrid

About the Role:

We are looking for a Scientific Writer II to join our team in Hyderabad. In this role, you 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, such as CSR, DSUR, Clinical Trial Registration Documents, and Patient Narratives.

  • Act as a documentation consultant in Clinical Trial Teams (CTTs) to ensure compliance with internal company standards and external regulatory guidelines.

  • Serve as a liaison between CTTs and publishing teams to ensure timely delivery of final documents.

  • Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.

  • Prepare publications to satisfy regulatory requirements and increase customer awareness of company products.

  • Ensure timely distribution of marketing samples (where applicable) to support regulatory, marketing, and customer outreach activities.

Commitment to Diversity & Inclusion:

Novartis is committed to fostering an inclusive work environment and building diverse teams that reflect the patients and communities we serve.

Essential Requirements:

  • Minimum: Life-science degree or equivalent (B.Sc./M.Sc./M.Pharm) with relevant clinical research experience (4 years for B.Sc., 2 years for M.Sc./M.Pharm).

  • Desired: Doctoral degree (PhD, MBBS, MD, or equivalent) with clinical research experience.

  • Excellent written and oral English skills.

  • Ability to manage and prioritize multiple projects effectively.

Desirable Requirements:

  • Ability to work independently and drive projects forward.

  • Strong organizational skills to handle multiple projects and collaborations efficiently.

Why Novartis:

At Novartis, our mission is to reimagine medicine to improve and extend lives. We believe that by bringing together passionate, collaborative people, we can achieve breakthroughs that change patients' lives. Join us in shaping the future of medicine.

Benefits and Rewards:

Explore the full range of benefits and rewards that Novartis offers in our Life Handbook.

Join Our Network:

If this role isn’t a fit for you, but you’re interested in learning about future opportunities, join the Novartis Network.

Division: Operations

Business Unit: Innovative Medicines

Location: Hyderabad (Office), India

Company / Legal Entity: Novartis Healthcare Private Limited

Functional Area: Research & Development

Employment Type: Full-time, Regular

Shift Work: No