Summary

This is an exempt, full-time position reporting to the Senior Director, Clinical Operations at Cerexa, Inc.
This position is responsible for the management of Clinical Document Control staff and paper document control systems in compliance with international and domestic regulatory requirements. This position will support Clinical Operations & Development to provide controlled records, protocols, reports, and strategize an electronic archival system.

Cerexa, Inc., a subsidiary of Forest Laboratories, is a pharmaceutical development company that is focused on a growing portfolio of novel anti-infective therapies for the treatment of serious and life-threatening infections.

At Cerexa, Inc., we conduct our business with the highest ethical standards. We believe that our ability to positively impact health and save lives is directly linked with the experience and insight that our employees possess and our style of working in collaborative teams. We maintain an environment that recognizes and rewards achievement. We believe in focused goals, and individual and team accomplishments. Because of the collective experience of the development and management teams, we are able to execute aggressive timelines to achieve realistic outcomes.

For more information about Cerexa, Inc., go to www.cerexa.com

Duties and Responsibilities

* Responsible for the Clinical electronic and paper document files. Responsibilities include, but are not limited to:
* Responsible for Trial Master Files
* Manage and train control document staff
* Responsible for projecting and implementing resource needs (staffing, equipment, etc.) to meet business goals and deadlines
* Create appropriate databases to track controlled documents
* Manage document templates and formats that comply with international regulatory requirements and guidelines
* Provide version control for controlled clinical documents
* Work with others in the organization to achieve smooth flow of routine information and documents
* Determine standard practices that mesh with current business practices/processes to allow efficient processing of clinical documents
* Create working guidelines and SOPs for department
* Coordinate access to clinical documents and records
* Maintain control of records as required by 21 CFR parts 11, 58 subpart J, 211 subpart J, 50, 54, 56, 312, and 314
* This position will have extensive, routine interactions with QA, QC, RA, Clinical, and Non-clinical groups
* Other duties may be assigned

Requirements

* High school diploma required; BS/BA degree preferred (equivalent knowledge or skills as acquired through the successful completion of an advanced degree are acceptable).
* Minimum of 5 years managing clinical documents and Trial Master Files; the final job title will be commensurate with the candidate's experience.
* Minimum of five years in the pharmaceutical or biotech industry.
* Experience managing high functioning team of control document personnel.
* Experience managing clinical documents for large, global, pharma studies, including EU.
* Demonstrated advanced expertise in MS Office 2000 (Word, Excel, Access, Outlook, Power Point) required. Specifically:
* Experience in MS Word creating large complex documents (50-2000 pages).
* Skilled in creating/editing tables, sections, headers and footers, templates, forms, styles, automatic numbering of sections and Tables of Contents, and macros.
* In Excel, skills in creating and maintaining spreadsheets to track documents, versions, distribution, etc.
* Strong knowledge and expertise in utilizing relational databases for the tracking and version control of documents and records, and tracking manufacturing data (part numbers, lot numbers, dates, disposition, etc.)
* Ability to evaluate document control systems, determine what changes maybe useful, and implement new systems, as necessary.
* Proven ability to accurately project document control resource needs.
* Works proactively and effectively in a fast-paced, high change environment.
* Flexible; adapts work style to meet organization needs; responds to changing priorities as directed by manager.
* Excellent interpersonal, written, and verbal communication skills; clear and concise.
* Demonstrated ability to build networks and inspire, coach, and manage a high performing team that embraces change and innovation.
* Understands and effectively responds to multi-cultural communication styles and business practices with global business partners.
* Strong problem-solving, project management, and organizational skills; detail-oriented.
* Utilizes big and small picture perspectives for strategic and tactical planning; understands impact of decisions across organization.
* Able to proactively identify and address areas of inefficiency and provide creative, effective solutions.
* Willingness to "roll up one's sleeves" in order to achieve goals.
* Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels; discrete.
* Committed to self-development and professional growth; solicits feedback from others.


Local (San Francisco Bay Area) candidates only


Notice to Recruiting Agencies and Search Firms:
Cerexa, Inc. prefers to recruit candidates directly, rather than through a third party recruiter or agency. Resumes submitted on this site by unauthorized third parties will not be considered for posted positions and are not eligible for placement fees. All third party agents and search firms must have an approved contract with Cerexa. Inc. to submit resumes on behalf of candidates. No other agreement with any other entity, including Forest, will fulfill this requirement.

If you have a signed agreement with Cerexa, Inc., please contact your Cerexa, Inc. staffing representative who will provide you with the appropriate link to submit your candidate.

Posting Date: 03.09.10