Medical Writing Specialist

2 weeks ago

Bengaluru, India Novo Nordisk Full time

The position

As a Medical Writing Specialist, you will be responsible for performing medical writing tasks of high complexity and acting as a project manager. Your role will involve planning, developing, and overseeing regulatory documents across all phases of clinical development. This includes but is not limited to, the preparation of Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Meeting packages and briefing books, Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries, and Clinical overviews. In this role, you will be expected to set direction, drive discussions, ensure decisions are made, and influence and implement project strategy. As a Medical Writing Specialist at Novo Nordisk, you will have the responsibilities to: Communicate clinical data clearly and concisely, contributing to process improvements, knowledge sharing, and skill building. Mentor and train other medical writers as needed, while maintaining good relationships with stakeholders and colleagues. Ensure timely, clear, and proactive communication and collaboration with stakeholders and colleagues globally. Assume the roles of Project Medical Writer (PMW) and Clinical Submission Team Lead (CST) for assigned projects. Meet timelines by planning work effectively, being proactive when problems arise, and seeking help and advice from relevant individuals within GBS and HQ. Support execution of Clinical Reporting strategy and vision in line with the leadership team. Challenge expert contributors on the clinical documents where the quality of their written contribution could be improved. Ensure the accuracy and compliance of documents with regulatory standards and guidelines through expertise and attention to detail. Qualification You are expected to have the following skills and knowledge: Graduate degree (PhD, MSc., M Pharm, or equivalent). ≥10+ years of experience as a medical writer or other relevant work experience. Experience in regulatory medical writing, including Clinical Study Reports (CSR), protocols, Investigator Brochures (IB), informed consent forms, clinical summaries, and clinical overviews. Excellent understanding of clinical development and regulatory processes and requirements. Experience working in a global setting. Experience in the pharmaceutical/CRO industry. Strong understanding of external requirements related to regulatory documents. Strong analytical skills, Excellent communication and presentation skills. Committed, persistent, and accountable. Able to handle numerous tasks simultaneously. Demonstrated ability to identify best practices and create improvements in methods, techniques, approaches, etc. Proven track record of being a proactive team player and delivering on time and with high quality. Working at NovoNordisk Novo Nordisk is a leading global healthcare company with a -year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63, employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life-changing.

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