Clinical Disclosure Specialist
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Job Location:
Gentofte Kommune - Denmark
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Are you passionate aboutclinical disclosure and transparency Do you have experiencewithinthe field
If so now is your chance to join Ascendis Pharma as our newClinical Disclosure Specialist.
Ascendis Pharmais a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovativeTransCon technology platform to fulfill our mission of developing new therapies thatdemonstratebest-in-class potential to address unmet medical needs.
At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany andadditionaloffices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development ofTransCon-based products in other therapeutic areas and markets.
We areseekinga passionateand responsibleClinical Disclosure Specialistto join our growing will play a crucial role in developing implementing and leading Ascendis clinicaltrialdisclosure processes and activities is an exciting opportunity to work in a fast-paced environmentcollaboratewith cross-functional global teams working together to achieve extraordinary results.
Youwill be joining theGlobal Regulatory Communicationsteamas the pioneerClinical Disclosure Specialist in AscendisandbebasedinCopenhagen.
Your key responsibilities willinclude:
- Overall responsibility forclinical trial disclosureactivities
- OwnCCImanagementprocesses
- Develop and implementrelevant processes including training of colleaguesin requirements
- Monitorand interpret globalandfuture CTDrequirements
- Collaborate cross-functionallywith clinical regulatory and other teams to meet disclosure requirements.
Qualifications and Skills:
You hold a relevant degreein a scientific discipline- preferably advance level-withminimum 5years of experience withinbiopharma and minimum 2 years in CTD.
Furthermoreyou have:
- Deep knowledge of global regulations and industry standards
- Experience in managing disclosure systems and processes including document redactionandanonymizationapproaches
- Excellent attention to detail and ability to handle sensitive information
- Provencommunicationstakeholder and projectmanagement skills.
Key competencies:
You area strong teamplayer analytical and have a can-do attitude.
Youpossessan entrepreneurial mindset and can thrive in an informal open environment where innovation and change are in this field you excel incollaboratingcross-functionally and driving best practices.
Apply now.
We evaluate applications when received so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.
To ensure your application is reviewed pleasesubmitit through the specified platform - applications sent by email or other channels will not be evaluated.
For more detailsabout the position or the company please contactVictoria Fuller-MikkelsenSenior Director GlobalRegulatoryCommunication
You can learn more about Ascendis by visitingour website
Applicationsmust besubmittedin English and will be treated confidentially.
A note to recruiters:
We do not allow external search party of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not this occurs your ownership of these candidates will not be acknowledged.
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a ... View more
