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Medical Writing Specialist
Category: Clinical Development
Location:
Bangalore, Karnataka, IN
Department - Clinical Reporting Unit
Does 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.
About the 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 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.
The position
The 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. In this position, you need to set direction, drive discussion, ensure decisions are taken and influence and implement project strategy.
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