Medical Writing Specialist

Novo Nordisk; Bengaluru; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

Novo Nordisk in Bengaluru seeks a Medical Writing Specialist to shape clinical documentation across therapeutic areas and lead clinical reporting content, translating complex trial data into clear, regulatory-grade documents.

You will guide content, methods and delivery, act as a primary stakeholder contact, and drive process improvements. Requires PhD/MSc/M.Pharm or equivalent and 10+ years in medical writing, with CSR, protocols, IBs, and regulatory submissions experience.

Qualifications

• Graduate degree holder with PhD, MSc, M.Pharm or equivalent.
• 10+ years in medical writing or related roles.
• Experience preparing CSRs, study protocols, IBs, informed consent documents, clinical summaries and overviews.
• Strong understanding of clinical development processes and regulatory submission standards.
• Experience in a global, cross-functional environment in pharma/CRO.
• Excellent analytical, communication and presentation skills.
• Ability to manage multiple priorities and drive continuous improvement.
• Proven track record as a proactive team player delivering high-quality work on time.

Responsibilities

• Deliver high-quality medical writing tasks and lead Clinical Reporting projects.
• Set direction for content, methods and working practices.
• Act as primary contact for stakeholders on clinical reporting deliverables.
• Develop project-specific writing guidance and improve methods.
• Drive knowledge sharing, training and best practices across projects.
• Lead process improvements while aligning with regulatory requirements.

Skills

Medical writing

Regulatory writing

Project leadership

Global collaboration

Stakeholder management

Education

PhD/MSc/M.Pharm or equivalent

Job description

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

We're looking for a specialist who combines deep medical writing expertise with the ability to set direction, guide others and align stakeholders across a global setting.

• 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.