Position: Medical Writing Specialist
Location: Bangalore, India
Job Category: Clinical Development
About the Department:
The Clinical Reporting Unit (GBS) at Novo Nordisk has rapidly expanded since its inception in 2011 and has become a critical part of the Global Clinical Reporting community. The team consists of skilled Medical Writers, Disclosure Medical Writers, Publishers, and Document Controllers with expertise in various therapeutic areas and regulatory requirements. Our mission is to provide clear and impactful communication on clinical trial outcomes and drive regulatory document submissions.
The Position:
As a Medical Writing Specialist, you will perform high-complexity medical writing tasks and take on the role of project manager for various clinical documents. Your responsibilities will include:
Preparation of regulatory documents across all phases, including Clinical Trial Protocols, Clinical Trial Reports (CTRs), Investigator Brochures (IB), non-interventional study reports (NSRs), regulatory response documents (Q&A), clinical summaries, and clinical overviews (NDA/MAAs).
Lead discussions and drive strategy for assigned projects, ensuring high-quality written contributions from expert contributors.
Act as the Project Medical Writer (PMW) and Clinical Submission Team Lead (CST) for your assigned projects.
Ensure timely and proactive communication with global stakeholders to meet deadlines and deliverables.
Continuously challenge and improve the quality of clinical documents, providing mentorship and guidance to other medical writers.
Key Responsibilities:
Medical Writing Leadership: Take ownership of the preparation, development, and oversight of regulatory documents.
Project Management: Plan, set direction, drive discussions, and ensure timely completion of documents while maintaining high quality.
Stakeholder Communication: Foster strong relationships and maintain clear communication with global stakeholders and team members.
Process Improvement: Contribute to process improvements, knowledge sharing, and mentoring junior medical writers.
Qualifications:
You should have:
A graduate degree (PhD, MSc, MPharm, or equivalent).
10+ years of experience as a medical writer or in a related role.
Extensive experience in regulatory medical writing, including Clinical Study Reports (CSRs), protocols, IB, informed consent, clinical summaries, and clinical overviews.
Strong understanding of clinical development and regulatory processes.
Experience in the pharmaceutical/CRO industry.
Ability to manage multiple tasks and prioritize effectively.
Excellent analytical, communication, and presentation skills.
A proactive and collaborative team player.
About Novo Nordisk:
Novo Nordisk is a leading global healthcare company dedicated to driving change in the fight against chronic diseases such as diabetes, obesity, and rare blood and endocrine diseases. With over 72,000 employees globally, we impact millions of lives daily, making us one of the 20 most valuable companies by market cap. We are committed to fostering a diverse and inclusive culture and helping our employees reach their full potential.
Application Details:
If you meet the qualifications and are ready to join a dynamic, growing team, we encourage you to apply using our online application tool.
Deadline: Please apply by 6th March 2025.
Important Notice:
Please be aware of fraudulent job offers purporting to be from Novo Nordisk. We do not extend unsolicited offers, nor do we request payment for recruitment processes. Always apply directly through our official platform.
Related Opportunities:
Global Publication Project Manager (Bangalore, India)
Senior Clinical Disclosure Professional (Bangalore, India)
Senior or Specialist Device Medical Writer (Søborg, Denmark)
Contact:
For questions about the position, please reach out through our application portal.
About Novo Nordisk:
Novo Nordisk A/S
Novo Alle 1, 2880 Bagsværd, Denmark
Phone: +45-4444-8888
CVR-no. 24256790
For more details, visit our product page.
Disclaimer:
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