US and EMEA-Emerging Markets (EM) Submission Publisher
The General Scope of Work will include publishing regulatory submissions in eCTD (Electronic Common Technical Document), NeeS (Non-eCTD Electronic Submission) and Paper formats and submitting them according to US and EMEA-EM requirements to the respective health authorities (HA) and/or to the Local Operating Companies (LOC). Depending on the assigned submission(s), required activities may include, but may not be limited to:
- Perform submission publishing activities in eCTD and non-eCTD format across US and countries within the EMEA-Emerging Markets (EM) region according to applicable Health Authority (HA) and dossier formats.
- Utilize current electronic document management and publishing tools to assemble, publish, validate and dispatch dossiers via electronic HA gateways or portals, or according to the regional regulatory requirements for paper and electronic formats
- Perform QC of electronic and paper submissions to ensure compliance with HA and internal requirements, guidelines, and processes.
- Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable.
- Maintain openly, timely and effective communications with all contributors and responsible RA professionals to ensure timely delivery of dossier for submission.
- BSc degree and 2-4 years of experience required in the pharmaceutical industry or related experience
- Experience in submission publishing processes and leading tools is mandatory with specific experience in Liquent Insight Publisher and ISI Publisher tools.
- Proficiency in applying submission-readiness and publishing standards via Adobe Acrobat, MS Word and related applications.
- In-depth knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines.
- Demonstrated ability to build productive relationships across an organization required
- Problem-solving capability, including trouble shooting and adaptability required.
- Understanding of the drug development process.
- Fluency in English.
- Beerse (BE)
If you’re interested in the above description, please apply with your CV. For further information, please contact Daria Petrova at +31 (0)20 20 44 502 or by email at d.petrova @panda-int.com