Associate Document Controller
1 month ago
Department: Clinical Reporting, NovoNordisk, GBS Bangalore
Are you detail-oriented and have experience in document management systems? Are you ready to join a dynamic team in the Clinical Reporting unit at Novo Nordisk? We are looking for an Associate Document Controller to distribute safety reports and maintain collaboration with stakeholders. If you are passionate about ensuring the accurate and timely distribution of critical documents, read on and apply today for a life-changing career.
The Position
As an Associate Document Controller, your responsibilities will include distributing safety reports such as SUSARs, CIOMS, and PSURs, as well as the Investigator’s Brochure (IB) to Novo Nordisk clinical trial sites globally through the CONNECT - Novo Nordisk Investigator Portal. Additionally, you will participate in knowledge-sharing and skill-building activities to maintain good collaboration with stakeholders.
Distribute safety reports (SUSARs, CIOMS, PSURs) and Investigator’s Brochure (IB) to Novo Nordisk clinical trial sites globally through CONNECT - Novo Nordisk Investigator Portal. Participate in knowledge sharing and skill-building activities. Maintain good collaboration with stakeholders.Qualifications
Post-graduate (Pharmacy, Science, IT, Engineering) or relevant bachelor’s degree Preferably 6 months of relevant experience in web-based Document Management Systems, MS Office and Portable Document Format (PDF) tools. General knowledge and understanding of FDA, EMA, ICH GCP and other regulatory electronic documentation requirements for safety reporting Ability to communicate, plan and coordinate multiple simultaneous activities Excellent communication and written skills. Strong stakeholder management skills.About the department
The Clinical Reporting unit in GBS has experienced significant growth since its inception in 2011, becoming a key part of the Global Clinical Reporting community within 6-7 years. Our team consists of enthusiastic and highly qualified Medical Writers, Disclosure Medical Writers, Publishers, and Document Controllers, many with advanced degrees in life sciences, pharmacology, and medicine. With an average of 7-8 years of experience in writing and reviewing regulatory documents, our team is known for its commitment, passion, and expertise across various therapeutic areas and regulatory requirements. We leverage our scientific knowledge to create clear and impactful communications about clinical trials. In addition to writing and publishing regulatory documents, we manage the distribution of documents through the CONNECT portal and play a vital role in Novo Nordisk's regulatory commitments through public disclosure activities
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Bengaluru, India Novo Nordisk Full timeDepartment: Clinical Reporting, NovoNordisk, GBS BangaloreAre you detail-oriented and have experience in document management systems? Are you ready to join a dynamic team in the Clinical Reporting unit at Novo Nordisk? We are looking for an Associate Document Controller to distribute safety reports and maintain collaboration with stakeholders. If you are...
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Bengaluru, Karnataka, India Novo Nordisk Full timeDepartment: Clinical Reporting, NovoNordisk, GBS Bangalore Are you detail-oriented and have experience in document management systems? Are you ready to join a dynamic team in the Clinical Reporting unit at Novo Nordisk? We are looking for an Associate Document Controller to distribute safety reports and maintain collaboration with stakeholders. If you are...
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