Job title: Team Lead Safety Medical Writer
Company: Novo Nordisk
Job description: Are you looking for a role as a Team Lead Safety Medical Writer? Join Novo Nordisk Global Business Services to have a life changing career!
About the department
The Global Safety department within the Global Business Services is responsible for processing ICSRs and for performing Safety Surveillance activities. Global safety has an outstanding track-record in case processing and writing aggregate reports. You will join a team of highly motivated employees, responsible for the safety of the patients.
The Job
You will be the operational team lead for Safety Medical Writers and a member of the safety surveillance team which is responsible for aggregate reporting. You will be majorly involved in planning and preparation of safety reports, when required. You will also ensure planning, coordinating and/or delivery of training and on-boarding of new employees in the safety medical writing team in GS-GBS. You will act as mentor for new safety medical writers, including buddy responsibility with reports.
As a Team lead Safety Medical writer, you will collaborate with Manager Safety Surveillance Reporting Medical Writing and facilitate functioning of the teams in Bangalore and DK as one global team. You will also do resource planning and prioritisation of department tasks to ensure optimal and flexible use of resources, and monitoring and reporting of department performance.
You will be setting targets for the team, manage process for performance management and individual development plans (IDP’s), drive continual improvement, contribute to setting direction for GS GBS and ensure that the business targets for the department are met and also drive development of the team and individuals by seizing and creating opportunities related to actual business needs. You will be supposed to collaborate within different departments within and outside of GS and maintain a good working relationship with stakeholders and counterparts. You will perform management review of safety reports according to the product split between Manager Safety Surveillance Reporting Medical Writing, or otherwise.
As per the need, you may also support with the planning and/or preparation of safety reports including DSURs, PSURs, RMPs, Response to health authority requests, Addendum reports etc., and ensure submissions are according to the submission plan, or as otherwise agreed with Regulatory affairs. If needed, may perform consistency review of documents as back-up SMW. Additionally, when relevant you will support the RMP and PSUR/DSUR process experts with performing reviews of reports, SOPs, guidance documents, and identifying and resolving process and compliance gaps. You will be responsible for content development in the preparation and update of SOPs and guidance documents and provide support.
Qualifications
University degree in medical/dental/biological/life science /pharmaceutical science
The below knowledge, skills and experience will be required:
- ≥2 years experience as project coordinator, people manager, task-people coordinator or ≥5 years experience from the pharmaceutical industry
- Excellent written and spoken English
- Substantial experience with MS Office (Outlook, Excel, Word, and PowerPoint)
- Excellent planning and coordination skills
- Motivated, Goal oriented and proactive
- You should have authority and competence to take up initiatives and also in making and presenting decisions
- Good stakeholder management, team oriented and flexible
- Multitasker and should have strong focus on quality
- Good interpersonal, presentation and communication skills
- Responsible, detail oriented and organised
Working at Novo Nordisk
At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent. In exchange, we offer you the opportunity to work with extraordinary talent globally and benefit from a range of possibilities for professional and personal development.
Contact
For further information, please contact at eksn@novonordisk.com
Deadline
31 December 2021.
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.
Expected salary:
Location: Bangalore, Karnataka
Job date: Tue, 14 Dec 2021 23:38:33 GMT
Apply for the job now!