Clinical Submission Coordinator

Clinical Submission Coordinator, Medical Documentation

Lundbeck aspires to impact patients, people, and society through leading innovation within neuro-specialty and neuro-rare fields, while delivering sustainable growth as a Focused Innovator. Your dedication to this strategy is crucial. That is why you can expect us to be committed to your progress, so you can stay committed to ours.

If you have a desire to manage clinical documentation and ensure that our deliverables meet the rigorous standards expected by regulatory agencies, you can be our new Clinical Submission Coordinator.

Your new role
You will be responsible for managing clinical documentation and for ensuring the submission readiness of clinical trial reports and clinical submission documents across Lundbeck’s clinical development programmes. You will ensure the electronic integrity of the documentation and compliance with internal and external standards and requirements. You will assist in the production of documents and perform quality control. You will be involved in activities to ensure public transparency of Lundbeck's clinical research.

All activities are planned and executed in close collaboration with Medical Writers, regulatory and clinical team members, as well as external vendors.

You will also be involved in the ongoing work at Lundbeck to evaluate trends, identify areas for improvement, develop and maintain processes and systems to optimize efficiency, and ensure quality in clinical documentation, as this role is continually evolving.

Your future team
We are a team that drive the development of clinical and regulatory documents and use our writing, story-lining, and collaboration skills to ensure that scientific information and clinical data are presented clearly and concisely. We are currently 12 colleagues in Medical Documentation. Your role is based in Lundbeck Valby with most of us; 2 of our colleagues are located in Singapore. We are imaginative, passionate, and responsible towards our deliveries, colleagues, and society. Ethics and transparency are key drivers. We focus on the well-being of the individual and we offer flexible working conditions in a positive and engaged working climate.

What you bring to the team
Our preferred candidate has the following personal and professional qualifications:

• degree in life science and knowledge of the pharmaceutical industry
• strong organizational skills and a methodological approach to work; ability to maintain a helicopter view without losing attention to details
• drive for and experience with how IT and systems can facilitate processes and procedures
• experience with clinical documentation, ideally related to clinical trials
• familiarity with Documentum-based systems and advanced knowledge in word-processing programs and how they can be applied to clinical documentation
• strong interpersonal and communication skills in a global environment
• fluency in spoken and written English

Our promise to you
Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn, Instagram (@h_lundbeck), or Twitter (@Lundbeck).

Apply now
Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you are not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions, please contact Kerstin Dahlström, Director Transparency and Outsourcing, [email protected], or Katarzyna Puton, Principal Clinical Submission Coordinator, [email protected] . Applications must be received by 2nd October 2024.

Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.