Medical Writer – Clinical Development & Regulatory Reporting
Location: Bengaluru, Karnataka, India
Company: Novo Nordisk
Department: Clinical Reporting, Global Business Services (GBS)
Job Type: Full-Time
Experience Required: Minimum 2+ years in Regulatory Medical Writing
Educational Qualification: PhD, MD, or Master’s degree (MSc / M.Pharm / Pharm.D or equivalent)
Overview
Novo Nordisk is hiring a Medical Writer to support its Clinical Development and Global Clinical Reporting functions. This role is ideal for professionals with expertise in regulatory medical writing who are passionate about translating complex scientific data into high-quality clinical and regulatory documents. You will play a key role in global drug development programs by delivering accurate, compliant, and strategically aligned clinical documentation.
Key Responsibilities
As a Medical Writer, you will develop, review, and manage a wide range of clinical and regulatory documents, including Clinical Trial Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), CTD Module 2 summaries, and regulatory response documents. You will ensure that all deliverables meet global regulatory standards and align with clinical reporting strategies.
You will act as a primary point of contact for stakeholders, facilitating discussions, aligning document strategies, and ensuring timely delivery of high-quality outputs. The role also involves interpreting clinical data, integrating project strategies into documents, and supporting both trial and non-trial clinical reporting activities.
In addition, you will contribute to process improvements, support knowledge sharing, and mentor junior team members to strengthen overall team capability. Maintaining up-to-date knowledge of regulatory requirements and applying a strong quality-focused mindset are essential aspects of this role.
Core Functional Expertise
Candidates should have hands-on experience in regulatory medical writing across multiple document types and a strong understanding of clinical development processes. Experience in the pharmaceutical, biotechnology, or CRO industry is highly desirable.
Required Skills and Competencies
Applicants must demonstrate strong scientific writing and data interpretation skills, with the ability to present complex information in a clear, concise, and audience-appropriate format. Excellent communication skills in English, both written and verbal, are essential.
Strong project management and stakeholder engagement skills are required to coordinate with cross-functional teams, including clinical, regulatory, biostatistics, and medical affairs. Candidates should be detail-oriented, quality-driven, and capable of managing multiple deliverables within tight timelines.
Adaptability, cultural awareness for global collaboration, and a proactive approach to continuous improvement are key attributes for success in this role.
About the Team
The Clinical Reporting team at Novo Nordisk GBS Bengaluru is a well-established and rapidly growing unit within the global clinical development ecosystem. The team consists of experienced medical writers and scientific professionals working across multiple therapeutic areas and regulatory frameworks. They collaborate closely with global stakeholders to deliver high-quality, submission-ready documents that support regulatory approvals and clinical decision-making.
Why Join Novo Nordisk
Novo Nordisk offers a purpose-driven work culture focused on improving global health outcomes. Employees gain exposure to international clinical development projects, benefit from continuous learning opportunities, and work in a collaborative environment that encourages innovation and professional growth.
Application Deadline: 8 April 2026
This is a strong opportunity for experienced medical writers to advance their careers in clinical development, regulatory writing, and global pharmaceutical research while contributing to impactful healthcare innovations.
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