As a key member of the Information Technology group, contribute in all aspects
to the department's and cross functional success. Manage close relationships
with all the clinical/regulatory functions. Work with the business owner(s)
to plan and support the analysis of complex business process, create efficiencies,
maintain consistencies and resolve business needs with automated systems. Provide
technical support and expertise to the business teams to identify, support,
evaluate and develop systems and processes that are cost effective and meet
user requirements.
Position reports to Senior Director, Information Technology.
- Support the Implementation of the Electronic Document Management System
(EDMS) (LiveLink);
- Maintain business applications in regards to validation, change control,
and configuration management; system administration
- Provide support for electronic submissions and FDA validation tools (e.g.
eCTD) to the FDA;
- Develop, maintain and update EDMS SOPs, as well as other Information Technology
related SOPs and controlled documents;
- Interpret user requirements, configure system to meet business needs, and
support the implementation of those requirements by developing specifications
and business process documentation;
- Support technical FDA pre-approval audits;
- Support QA department from an IT perspective;
- Support the implementation, administration and change management of a Drug
Safety Information System (Argus);
- Represent the Information Technology group in department and cross-functional
initiatives;
- Bachelors or Masters degree in science or business related field;
- Minimum 6 years (with Bachelors degree) or 4 years (with Masters degree)
of relevant experience in the pharmaceutical or biotech industry;
- Direct experience with performing electronic submissions using electronic
submission tools applications such as ISI eCTD express, Core Dossier etc.
- Thorough understanding of submission validation, eCTD, FDA Reviewers tools,
and XML check sums;
- Direct experience with 21CFR Part 11 in relation to implementation and testing
of business processes into an EDMS such as Livelink or Documentum
- Direct experience with configuration management and process development
and system integration;
- Experience with system administration and management of application security
schemas;
- Strong technical knowledge in database technologies, and query and reporting
tools, such as SQL, Business Objects and SAS;
- Working knowledge of medical terminologies, e.g. MedDRA;
- Excellent presentation and communication skills to analyze problems and
discuss solutions with colleagues, project team members and users;
- Ability to work independently and act with minimum supervision in a fast
paced environment; and
- Must be team oriented and able to manage multiple tasks and business projects
with cross functional groups.
Affymax, Inc.
Human Resources
4001 Miranda Avenue
Palo Alto, CA 94304
careers@affymax.com
