Job Description

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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...CategorySelect how often (in days) to receive an alert:xc3x97Select how often (in days) to receive an alert:Medical Writing SpecialistCategory: Clinical DevelopmentLocation:Bangalore, Karnataka, INDepartment - Clinical Reporting UnitDoes your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment 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. Apply now and join a growing team, working in an international environment.The positionThe key responsibilities in this position will be to perform medical writing tasks of high complexity and act as project manager. Plan, develop and oversee regulatory documents across all phases including but not limited to preparation of Protocols, Clinical Trial Reports (CTRs), non-interventional study reports (NSRs), Meeting packages and briefing book, Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries and Clinical overviews (NDA/MAAs). In this position, you need to lead, set direction, drive discussions, ensure decisions are taken and influence and implement project strategy.

• You will have to communicate the clinical data in a clear and concise manner. You will contribute to process improvements, knowledge sharing, skill building, and mentor and train other medical writers as needed. You will have to maintain good relationship with the stakeholders and colleagues.
• Ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. Assume role as Project Medical Writer (PMW), Clinical Submission Team Lead (CST) for assigned project.
• Responsible in order to meet timelines, the medical writer must be good at planning own work and be proactive when problems arise and seek help and advice from relevant people within GBS as well as within HQ.
• Support execution of Clinical Reporting strategy and vision in line with the leadership team. You will challenge the expert contributors on the clinical documents where the quality of their written contribution could be improved.

QualificationYou are expected to have the below skills and knowledge:

• Graduate (PhD, MSc., M Pharm, or equivalent).
• xe2x89xa510+ years of experience as medical writer or other relevant work experience.
• Experience in regulatory medical writing, Clinical study Report (CSR), protocol, IB, informed consent and clinical summaries and clinical overviews.
• Excellent understanding of clinical development and regulatory processes and requirements.
• Experience working within a global setting.
• Experience from 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.
• Requires good communication and analytical skills.
• Demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc.
• Established record of being a proactive team-player and able to deliver on time and with high quality.

About the departmentThe Clinical Reporting unit in GBS has seen a tremendous growth curve and has become an integral part of the Global Clinical Reporting community in a short span of 6-7 years, since its inception in 2011. The team is a dynamic mix of enthusiastic and qualified skilled Medical Writers, Disclosure Medical Writers, Publishers and Document Controllers 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 7-8 years in writing and reviewing regulatory documents and publications. We use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. Apart from writing and publishing regulatory documents, the team is also responsible for distribution of documents (CONNECT portal) and largely contributes to NN's regulatory commitments by being involved in Public disclosure activities.Working at Novo NordiskNovo Nordisk is a leading global healthcare company with a 100-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 72,000 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.ContactIf you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.DeadlineApply on or before: 28th March 2025.DisclaimerIt has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment processWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

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