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Medical Writer

2+ years
Not Disclosed
10 Feb. 24, 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: Medical Writer
Location: Bangalore, India
Job Category: Clinical Development


The Position:

As a Medical Writer at Novo Nordisk, you will be responsible for producing clear and accurate clinical documentation for both trial and non-trial activities. You will ensure proactive communication and collaboration with stakeholders and colleagues across global time zones. This role requires strong communication and analytical skills, as well as the ability to manage timelines and plan work independently. Your key responsibilities will include:

  • Writing clinical documents such as Protocols, Clinical Trial Reports (CTRs), Non-interventional Study Reports (NSRs), Layperson Summaries (LPS), Investigator Brochures (IB), and Regulatory Response Documents (Q&A).

  • Communicating clinical data in a clear, concise, and scientifically accurate manner.

  • Collaborating with various stakeholders and maintaining strong relationships with colleagues globally.

  • Ensuring the quality of clinical documents by reviewing and challenging expert contributors where needed.


Qualifications:

To succeed in this role, you should possess:

  • A graduate degree (PhD, MSc., M Pharm, Pharm D, or equivalent).

  • 2+ years of experience as a medical writer or in a related field.

  • Experience working within a global setting, preferably in the pharmaceutical or CRO industry.

  • A strong understanding of regulatory document requirements.

  • Excellent communication skills and the ability to work independently.

  • Strong analytical skills, with a commitment to delivering high-quality work.

  • Ability to manage a variable workload and handle tasks independently.


About the Department:

The Clinical Reporting Unit within GBS is integral to the Global Clinical Reporting community. Since its inception in 2011, the team has grown rapidly and now comprises skilled medical writers, disclosure medical writers, publishers, and document controllers. With broad expertise across various therapeutic areas and regulatory requirements, the team plays a crucial role in regulatory submissions and public disclosure activities, ensuring clear and impactful communication of clinical trial outcomes.


Working at Novo Nordisk:

Novo Nordisk is a global healthcare leader, renowned for its 100-year legacy in transforming the treatment of chronic diseases such as diabetes, obesity, and rare blood and endocrine diseases. We are one of the top 20 most valuable companies in the world, impacting over 40 million patient lives daily. Our success is driven by the collaboration and potential of our 72,000+ employees. At Novo Nordisk, we strive to bring out the best in our people, fostering a culture of inclusion, innovation, and collective effort.


Application Details:

To apply, please submit your CV and motivational letter via our online application tool.

Deadline: 6th March 2025.