Associate Director, Medical Writing
ImmunityBio, Inc.
Senior Associate, Global Regulatory Operations
Ultragenyx
contract
Posted on:
Origin: • 🇳🇱 Netherlands
Visit company websiteJob Level
Senior
About the role
- Performs moderately complex to non-routine submission formatting activities associated with generating hard copy and electronic submission-ready documents and reports.
- Electronically compiles all components of moderately complex submissions using Lorenz DocuBridge™ and associated publishing tools including but not limited to: eCTDs - National and Centralized Procedures; Post Marketing/Life-cycle Management: Type Ia, Ib and II Variations & Renewals; Orphan Drug Documents, Scientific Advice and PIPs.
- Dispatches submissions through the relevant gateways/portals (e.g. EMA Submissions Gateway and US Gateway and/or other channels) and electronically archives them according to the departmental practices.
- Participates in supporting and promoting current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
- May interface with cross-functional teams and or content authors to discuss routine submission preparation and content.
- May assist and/or provide training to others on software tools used and educating authors in publishing policies and procedures.
- Identifies and records issues that require resolution prior to finalization and liaises with the author responsible to resolve issues. Assists authors in the completion and compilation of regulatory documents to ensure all components are provided and presented in the correct format.
- Exercises judgment within well-defined procedures and practices to determine appropriate action.
Requirements
- BA or BS degree with 3+ years of Regulatory Operations experience or an equivalent combination of education and experience preferred.
- Strong experience with EU submissions, but also some experience with submissions in other regions (US, CA, ROW, etc.)
- Experience in successfully working in a fast-paced environment with tight timelines, large deliverables.
- Ability to manage multiple ongoing projects simultaneously.
- Must have excellent verbal and written skills, very strong organizational and time management skills.
- Must have a very strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
- Should demonstrate flexibility and willingness to accommodate ad-hoc requests and work effectively within an environment that has quickly changing processes, priorities and deadlines as well as to work overtime in order to meet required timelines.
- Must have a strong working knowledge and understanding of MS Word, Word templates, Adobe Acrobat, ISIToolBox, eCTD validation software, Lorenz DocuBridge (or other eCTD submission publishing tools) and standard Office tools.
