Are you passionate about clinical trial submissions? Do you possess a talent for overseeing project management and ensuring compliance with global requirements? If so, we have an exciting opportunity for you to join our newly established team of Submission Managers at [xxxxx]. This is a great opportunity to be part of defining our future processes and make a difference for clinical trials teams. Read more and apply today for a life-changing career.
The position
As a Submission Manager at [xxxxx], you will lead and be accountable for the submission of initial Clinical Trial Applications (CTAs) and amendments to Health Authorities (HAs) and Ethics Committees (ECs) in alignment with business needs and priorities. This new role has been introduced to strengthen the current process and establish a center of excellence. You will collaborate closely with various stakeholders across Development and Affiliate to ensure timely and compliant submissions on a global scale.
Your key responsibilities will include:
Leading the CTA submission process effectively and applying best practices to ensure timely submission of CTAs. Ensuring CTA submission is in compliance with all applicable requirements worldwide and driving better practice and consistency across trials. Coordinating the preparation and monitoring the compilation of CTA documents for submission of initial CTAs and amendments. Providing daily support to the team in analysis and problem-solving related to CTA submis-sion activities. Providing continuous input to CTA process and system improvements to drive best practice and efficiency gains across CTA submissions.
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and onsite work in Søborg, Denmark where our team is based. Qualification
To succeed in this role, you should: Hold a Bachelor's or Master's degree in Life Science or a relevant field. Have experience within the pharmaceutical or medical device industry. Demonstrate project management expertise and experience in managing trials/projects. Exhibit experience in cross-functional organizational work, representing trial management views. Possess extensive experience in all operational aspects of start-up, planning, conduct, and finalization of CTAs. Be proficient in English.
As a person, you bring strong project management skills to the table, along with flexibility and cross-cultural awareness. You have the ability to inspire and motivate stakeholders, and your overall overview and analytical capabilities are exemplary. Moreover, your good communication, presentation, negotiation, and influential skills make you a valuable asset. Additionally, you possess the ability and willingness to adjust quickly to new situations in a continuously developing environment.
About the department
You will be part of a dynamic and dedicated team responsible for running all clinical development activities from initial planning of clinical trials towards authority submission. CTA Management is a department in constant development, and we are working closely with our stakeholders to continuously improve our processes to adapt and ensure compliance with the increasingly complex regulatory environment. We offer interesting and challenging assignments and good opportunities for continuous personal and professional development.
Working at [xxxxx]
At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Henriette Westphal, Associate Director at [xxxxx]
Deadline
18 March 2025.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] 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.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 10.12.2024, men kan have været deaktiveret og genaktiveret igen.
