Medical Writing Specialist

Novo Nordisk India Pvt Ltd; Bengaluru; Vor Ort; INR 1.800.000 - 3.000.000; Vollzeit

Zusammenfassung

Novo Nordisk India Pvt Ltd in Bangalore is seeking a Medical Writing Specialist to shape how clinical science is documented across therapeutic areas and to translate demanding data into clear, credible documents to support regulatory progress. The role requires a PhD/MSc/M.Pharm or equivalent with 10+ years in medical writing, CSR and protocol experience, and strong communication and presentation skills.

You will collaborate with global teams and drive continuous improvement in a fast-paced GBS

Qualifikationen

• PhD/MSc/M.Pharm or equivalent required.
• 10+ years of medical writing experience.
• Experience with CSR, study protocols, IBs, and clinical overviews.
• Strong regulatory understanding and cross-functional collaboration.

Aufgaben

• Lead clinical reporting content and drive direction for medical writing deliverables.
• Act as Clinical Reporting Project Lead or Medical Writing Lead.
• Set direction for content and methods in clinical reporting.
• Serve as primary contact for stakeholders on clinical reporting deliverables.
• Develop project-specific writing guidance and improve methods.

Kenntnisse

Medical writing

Regulatory writing

CSR preparation

Clinical study protocols

Cross-functional collaboration

Ausbildung

PhD/MSc/M.Pharm

Jobbeschreibung

Medical Writing Specialist Company – Novo, Global Business Services Department - Research & Development Location - Bangalore, India Does your motivation come from challenges and working in a dynamic environment? Do you thrive where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can‑do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you.

Your new role

As a Medical Writing Specialist, you will shape how Novo Nordisk's clinical science is documented and communicated across therapeutic areas. You will lead clinical reporting content, set direction on complex medical writing deliverables and translate demanding scientific data into clear, credible documents. Your work moves clinical development forward, supporting regulatory progress and, ultimately, lasting health for people living with serious chronic diseases.

Your day‑to‑day tasks will include:

• You will act as a specialist and informal leader, delivering high‑quality documents while setting direction for content, methods and ways of working.
• Manage and deliver a wide range of medical writing tasks to a consistently high standard and take the role of Clinical Reporting Project Lead or Medical Writing Lead.
• Set direction, drive discussion and ensure decisions align with the clinical reporting strategy for content and documents.
• Act as the primary contact for stakeholders on clinical reporting deliverables, identifying need, timing and scope, and representing clinical reporting in project groups.
• Develop project‑specific writing guidance and establish new and improved methods within your field of expertise.
• Drive knowledge sharing, skill building and better practices across projects and indications, and provide therapy‑area support and training to other writers.
• Lead process improvements and efficiency initiatives while fostering a quality mindset and staying current on global regulatory requirements.

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, qualified and skilled Regulatory Medical Writers 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.

Your skills & qualifications

• Graduate degree holder - PhD, MSc, M.Pharm, or equivalent.
• 10+ years of experience in medical writing or other relevant roles.
• Proven experience in preparing Clinical Study Reports (CSRs), study protocols, Investigator’s Brochures (IBs), informed consent documents, clinical summaries, and clinical overviews.
• Excellent understanding of clinical development processes, regulatory requirements, and submission standards.
• Experience working in a global and cross‑functional environment.
• Prior experience within the pharmaceutical and/or CRO industry.
• Strong knowledge of external regulatory requirements related to clinical and regulatory documentation.
• Excellent analytical, communication, and presentation skills.
• Highly committed, accountable, and results‑oriented, with a persistent approach to achieving objectives.
• Ability to effectively manage multiple priorities and tasks simultaneously.
• Demonstrated ability to identify best practices and drive continuous improvements in methods, processes, and approaches.
• Proven track record as a proactive team player, consistently delivering high‑quality work within established timelines.

Working at Novo

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years, this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect, and a willingness to go beyond what we know delivers extraordinary results.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline 12th Oct 2026.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Experience Level Mid Level