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Experienced Regulatory Submissions Publisher

 
Requistion ID:  1622
Location: 

Copenhagen, Hovedstaden, DK

Date:  21-Mar-2021
 

Experienced Regulatory Submissions Publisher – Regulatory Data & Submission Management.

 

Lundbeck’s passion links to our purpose about restoring brain health so every person can be their best. We strive to make a real difference to patients. By developing innovative treatments, we improve the lives of people living with brain diseases. Your dedication is crucial. That is why you can expect us to be committed to your progress, so you can stay committed to ours.

 

Description

 

We are looking for an experienced Publisher to compile and manage our Regulatory Submissions within Regulatory Data & Submission Management. This person will in addition be responsible for prioritization and coordination of team deliverables.

Regulatory Data & Submission Management is responsible for key operational activities in connection with compilation and submission of marketing authorisation applications worldwide, as well as regulatory data management, and implementation of labelling and manufacturing changes in the production area.

Furthermore, Regulatory Data & Submission Management is also responsible for system ownership and administration of business critical systems for regulatory data management.

Regulatory Data & Submission Management is part of Regulatory Affairs, Medical Documentation and R&D Quality.

The position is based in Lundbeck’s headquarters in Valby (Copenhagen, Denmark) and the department consists of 10 highly experienced employees.

 

Your job and key responsibilities

As Experienced Regulatory Submission Publisher your main areas of responsibility will be:

  • Global operational activities related to compilation and publishing of marketing applications (initial application, variations, renewals, PSUR etc.), including:
    • QC and clean-up of documentation for regulatory submissions
    • Compilation of regulatory documents
    • Providing guidance on standards and technical requirements in relation to publishing
    • Participating in cross-organizational submission teams
  • Lead, prioritize, delegate and follow-up on team deliverables in collaboration with Senior Manager
  • System owner deputy responsible for Lundbeck publishing system (Liguent InSight moving to Lorenz docuBridge)
    • Operations, maintenance and change management of publishing system

 

You will co-operate with colleagues in Regulatory Affairs, Medical Documentation and R&D Quality globally and colleagues throughout the Lundbeck Value Chain.

The job can, at times, be fast paced and the tasks are often associated with tight deadlines.

 

We offer

We offer you the opportunity to be part of a dynamic team and work in a truly global environment with exciting activities and an open working atmosphere.

Lundbeck offers a great workplace that is based on a flat structure, forming a

collaborative working environment based on respect and equality. We employ dedicated colleagues and encourage continuous development. Together, we create the ideal conditions for you and your job, so we can create better conditions for patients.

 

Qualifications

Our preferred candidate has the following personal and professional qualifications:

  • Solid experience in the field of publishing (including publishing tools and electronic document management systems)
  • Experience from working within Regulatory Affairs, Regulatory Processes and Operations is an advantage
  • Proficient in working with IT systems and databases
  • Service minded, structured and detail-oriented
  • Flexible and thrive in a fast-paced environment with frequent tight deadlines
  • Analytical, goal oriented and strong finisher
  • Experience with coordination and coaching of teams would be considered an advantage
  • Fluent in English

 

Further information

For further information, please contact Senior Manager Angelina Gindeberg on +45 30 83 22 92. Your application and CV should not be sent via email.

We also recommend that you have a look at our website, LinkedIn and Instagram.

 

Your application

Please click on the apply button. Applications must be received no later than 23 April 2021.

 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
 
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
 
Read more at www.lundbeck.com/global/about-us/progress-in-mind
 
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.