Vacancy expired!
- Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC.
- As a global submissions’ expert, ensure the project team has awareness and knowledge of submissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.
- Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.
- Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.
- Manage activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health agencies.
- Maintain technical expertise of regulatory requirements and ensures alignment with company processes and client requirements
- Act as a subject matter expert for document management system.
- Compile regulatory submissions. Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product life-cycle information.
- Lead and manage special projects as needed.
- Bachelor’s degree in a scientific discipline or systems technology or equivalent
- 4-6 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)
- Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools
- Extensive knowledge of North American/Global submission standards (FDA, Health
- Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.)
- Knowledge of CDISC (ADaM, SEND, SDTM)
- A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)
- Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.
- MS PowerPoint skills
Vacancy expired!