Document manager - Basel

Basel  ‐ Vor Ort
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Beschreibung

Major Accountabilities
1. Perform source data verification (SDV) and technical quality control (QC) of submission documents (simple to medium complexity) to ensure both content and format fulfil requirements. Collaborate with globally located scientific personnel to ensure finalization of the documents, according to timelines and quality requirements.
2. Compile, integrate and publish applicable documents with state-of-the-art word pro-cessing, electronic publishing and document management systems in collaboration with the responsible author(s).
3. Work with external consultants (vendors) to coordinate outsourced QC activities related to the processed tasks. Responsible for verifying and consolidating the QC recommendations from the external consultants and partner with the respective document author(s) to reconcile findings and finalize the submission document(s).
4. Resolve technical document or workflow issues as applicable on the documents being processed.
5. Advise authors, newcomers and vendors on SDV requirements, technical formatting processes and the use of Novartis' document management systems.
6. Remain abreast of current processes, regulatory guidelines and legal requirements, as relevant.
7. Collaborate with Submissions Management team on specialized projects, to support key submission deliverables.
8. Collaborate to provide metrics, KQIs and KPIs.
Key Performance Indicators
* Completion of an adequate number of regulatory documents (taking into account complexity and size)
* Timeliness of deliverables, such that both individual document review KPIs are satisfied and overall project timelines are adhered to.
* Proactive and collaborative communication with key stakeholders based on feedback from internal colleagues and customers.

Job requirement
Education (minimum/desirable): Undergraduate degree preferably in a scientific discipline or equivalent work experience
Languages: English fluent (oral and written)
Experience/Professional Requirement:
* 3-5 years of relevant work experience with electronic document management systems and document review.
* Basic understanding of clinical and nonclinical infor-mation contained in a submission dossier.
* Demonstrated ability to work successfully within a ma-trix environment and influence cross-functional teams.
* Flexible and detail oriented approach to documenta-tion management, as appropriate.
* Experience with and ability to understand compliance practices, which include GxPs and Standard Operating Procedures.
* Proficient in Microsoft office programs (e.g. MS Word).

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
11/2019
Dauer
12 months
Von
Michael Bailey Associates
Eingestellt
30.10.2019
Projekt-ID:
1841729
Vertragsart
Freiberuflich
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