Sr Regulatory Doc Spec

How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.
This position will be responsible for archiving health authority submissions and correspondence and supporting the transition to a fully electronic archive.
The individual will scan, import and index submissions and correspondence into a Documentum based document management system.
The individual will assist other groups in locating information in paper and electronic formats. Copies of this information will be created as needed.
The individual will support legal and due diligence reviews.
The individual will develop and maintain SOPs and work on special projects as needed.
The successful candidate will be detail-oriented, self-motivated, a good problem solver and will be able to operate well in a dynamic fast-paced environment.
The successful candidate has familiarity with the basic structure and content of INDs, NDAs and CTDs, as well as an understanding of the basics of drug development.
The ideal candidate has previous electronic archiving experience.Qualifications
BA/BS minimum. A degree in life sciences is a plus.
Five years experience in the pharmaceutical industry (or related experience).
Good and effective interpersonal skills with abilities in customer service to interact with individuals at various levels of the organization and external contacts.
Individual should be highly motivated and a self-starter.
Knowledge of INDs, NDAs and CTDs.
Good computer skills including a broad knowledge of the PC desktop environment, Microsoft suite of products, Windows XP, Adobe Acrobat, Lotus Notes Mail, as well as CD Burning and Scanning.
Experience working in Documentum is a plus.
Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.