Are you passionate about ensuring the quality and safety of pharmaceutical products? Do you have experience in post marketing surveillance and project management? If so, you might be the perfect fit for our team! Read more and apply today for a life-changing career.

The Position

The person in this posiiton will be responsible for supporting of planning and management of all regulatory post marketing surveillance(rPMS) activities in Korea in a timely and effective manner, within budget and complying with regulatory requirements, Helsinki Declaration, ICH-GCP/GPP (Good Pharmacoepidemiology Practice) and NN SOPs (Standard Operating Procedures)

Roles & Responsibilities

• Support/lead PMS / PASS projects in the country
  • Be responsible for supporting management of PMS / PASS projects, which includes planning, conduct and coordination of project activities, providing operational and therapeutic expertise to the project
  • Ensure compliance with all Novo Nordisk policies, essentials and procedures, ICH-GCP/GPP and applicable law and regulations
  • Be accountable for all project timelines and deliverables from protocol outline to study reporting
  • Monitor recruitment and reporting status and take appropriate actions according to the agreed country plan
  • Ensure review, approval and follow-up of monitoring visit reports including protocol deviations and perform co-monitoring visits within the project, if needed.
  • Meet all local and company requirement with respect to safety reporting
  • Monitor the quality of the project execution, quality audits and inspection issues including quality oversight of vendor activities
  • Ensure that budgets are managed in line with the plan under the supervision of the line manager
  • Ensure filing and archiving of study related documents in the Trial Master File, and update any clinical trial management system (e.g. COSMOS) at trial / country level (supported by CTA)
  • Initiate and drive contracts with a vendor and sites as per local practise (supported by CTA)
  • Negotiate non-interventional study agreements with local investigators/sites
  • Collaborate with line manager and team members in effective site recruitment, providing the necessary criteria for successful staffing

• Provide PMS / PASS related communication and insight to key internal and external stakeholders
  • Ensure effective communication of all PMS/PASS related issues between HQ and affiliates
  • Provide project status update and key operational information as required to line manager
  • Provide vendors (e.g., CRO) and external clients with timely project status information
  • Provide input to develop study related documents for local meeting and selection/initiation visits if applicable
  • Provide consolidated country input for review of key documents (e.g. protocol outline, protocol and related documents)
  • Maintain timely communication with HA and IRB/ECs, ensuring HA / EC is provided with the documents requested
  • Support any audits/inspections of local organization

Qualifications

• Minimum Bachelor degree in Medicine, Pharmacy, Nursing, Life Sciences or equivalent is preferred
• At least 3 years of working experience in clinical trials, PMS/PASS, CRA is preferred
• Preferably, candidates with 2 years of experience as a project lead in a global pharmaceutical company or CRO
• ICH GCP trained and if applicable, certified

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

Upload your CV to our online career page (click on Apply and follow the instructions).

Deadline

Until the completion of recruitment.

Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

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.

#LI-AMS1