Associate Document Controller

Category:  Clinical Development
Location: 

Bangalore, Karnataka, IN

   

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

 

Working at Novo Nordisk

 

Novo 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 63,000 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.

 

Contact

 

To submit your application, please upload your CV online (click on Apply and follow the instructions).

 

 

Deadline

 

31st May, 2024

We 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.