Medical Writer

Team: Clinical Reporting

Location : Bangalore, Novo Nordisk Global Business Services (GBS), India

Your New Role

As a Medical Writer, you will perform a wide range of medical writing tasks to support clinical development programs, delivering high-quality content and documents that align with the Clinical Reporting strategy. The tasks for trial and/or non-trial activities within clinical reporting will include but will not be limited to preparation of Protocols, Clinical Trial Reports (CTRs), Investigator Brochure (IB), CTD Module 2 summaries and overview (clinical submission documents) and Regulatory response documents (QA).

You will act as a primary contact for stakeholders on Clinical Reporting-driven content, drive discussions to ensure decisions align with strategy, and represent Clinical Reporting in relevant project groups.

Key responsibilities

Efficiently manage and deliver on clinical reporting and medical writing deliverables while maintaining high quality standards.
Implement project strategies into documents and review project/study-specific materials as needed.
Engage stakeholders to identify needs, timing and scope of clinical reporting deliverables and ensure alignment with the Clinical Reporting strategy.
Support execution of the Clinical Reporting vision and contribute to process improvements and efficiency initiatives.
Share knowledge, mentor colleagues, and contribute to training activities to build capability across the team.
Apply a quality mindset and maintain up-to-date knowledge of global regulatory requirements and policies relevant to your work.

Your Skills and Qualifications

Must have PhD, Medical degree or Masters degree (MSc, M Pharm, Pharm D or equivalent) combined with relevant experience.
Experience: At least 2 yearsexperience in regulatory medical writing
Experience across a broad range of scientific writing tasks; experience in the pharmaceutical industry or equivalent is desirable
Able to work independently on well-defined tasks with appropriate guidance, strong analytical skills, persistence, accountability, and ability to manage variable workloads.
Communication: Fluent in written and spoken English with the ability to translate complex scientific data into clear, concise, and engaging content tailored to diverse audiences.
Collaboration stakeholder management: Good project management skills; skilled at fostering cross-functional collaboration across multidisciplinary teams and maintaining professional, trustworthy communication with integrity.
Additional attributes: Cultural awareness for global collaboration, willingness to seek feedback and continuously improve, and a quality-focused mindset.

Your New Department

The Clinical Reporting unit in GBS has seen a tremendous growth curve and has become an integral part of the Global Clinical Reporting community, since its inception in 2011. The team is a dynamic mix of enthusiastic and qualified skilled Medical Writer and, Disclosure Medical Writers with Masters/PhD in life sciences, pharmacology, medicine, etc. The team is full of commitment, passion, skills, and talent with broad knowledge on different therapeutic areas and regulatory requirements for submissions. The team has an average experience of 7 to 8 years in writing and reviewing regulatory documents. We use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. The department partners closely with cross-functional stakeholders across Medical and Science, Clinical Pharmacology, Biostatistics, Trial Execution, and Regulatory Affairs. The department emphasizes knowledge sharing, innovation, and continuous improvement to support multi-regional clinical studies and ensure cohesive, high-quality deliverables.

Experience Level

Senior Level

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Medical Writer

Job Description

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