Medical Writing Specialist

10+ years

Not Disclosed

Bengaluru

10 March 19, 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

Job Title: Medical Writer - Clinical Development
Location: Bangalore, India
Department: Clinical Reporting Unit
Job Category: Clinical Development

Join a Dynamic Team in Clinical Reporting

Are you motivated by challenges and working in a dynamic environment? Do you thrive in a setting where close collaboration with key stakeholders and strategic alignment are essential? If you're a driven professional with a passion for continuous improvement, we have an exciting opportunity for you. Apply now and become a part of our growing team at Novo Nordisk, working in an international environment.

Position Overview:

As a Medical Writer in the Clinical Reporting Unit, your primary responsibilities will include leading medical writing tasks of high complexity while acting as a project manager. You will plan, develop, and oversee regulatory documents across all phases, including but not limited to:

Protocols
Clinical Trial Reports (CTRs)
Non-interventional Study Reports (NSRs)
Investigator Brochure (IB)
Clinical Summaries & Overviews (NDA/MAAs)
Regulatory response documents (Q&A)

Additionally, you'll be responsible for leading discussions, setting direction, influencing project strategy, and ensuring decisions are made. You will also communicate clinical data clearly and concisely and support process improvements, knowledge sharing, and mentoring other medical writers.

Key Responsibilities:

Lead and Manage Projects: Set direction, drive discussions, and ensure timely delivery of clinical documents.
Regulatory Document Development: Plan, write, and oversee complex documents like clinical protocols, study reports, and regulatory submissions.
Collaboration & Communication: Maintain effective communication with stakeholders and colleagues globally to ensure proactive collaboration.
Quality Control: Challenge contributors to improve the quality of their written submissions.
Process Improvement: Contribute to continuous improvement in writing methods, techniques, and approaches.
Mentorship: Mentor and train junior medical writers to enhance team capabilities.

Qualifications:

Educational Background: Graduate (PhD, MSc, M Pharm, or equivalent).
Experience: At least 10+ years of experience in medical writing or a related field, with expertise in clinical study reports (CSR), protocols, Investigator Brochures, informed consent forms, and clinical summaries.
Skills & Knowledge:
- In-depth understanding of clinical development and regulatory processes.
- Strong experience in the pharmaceutical/CRO industry.
- Familiarity with external requirements for regulatory documents.
- Exceptional analytical, communication, and presentation skills.
- Proven ability to handle multiple tasks simultaneously and deliver high-quality work on time.
- Strong commitment, persistence, and accountability.
- Ability to identify opportunities for process improvement.

About the Department:

The Clinical Reporting Unit within Global Business Services (GBS) has experienced remarkable growth, establishing itself as a key part of the Global Clinical Reporting community. The team is a dynamic mix of skilled medical writers, document controllers, and publishers with expertise in life sciences and pharmacology. The unit plays a critical role in regulatory submissions, public disclosures, and creating clear, impactful communications on clinical trial outcomes.

Why Novo Nordisk?

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat chronic diseases. We are growing rapidly and impacting the lives of millions of patients worldwide. As one of the top 20 most valuable companies globally, we value the diverse perspectives and skills of our employees, working together to improve patient lives.

Contact:

If you are a match for the above requirements and eager to take on this exciting role, please apply online through our application tool.

Deadline:

Apply by 28th March 2025.

Disclaimer:
Please be aware of fraudulent job offers. Novo Nordisk does not extend unsolicited offers or request payments during the recruitment process.

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Medical Writing Specialist

Job Description

Join a Dynamic Team in Clinical Reporting

Position Overview:

Key Responsibilities:

Qualifications:

About the Department:

Why Novo Nordisk?

Contact:

Deadline:

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