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RECMGMT-L  January 2001

RECMGMT-L January 2001

Subject:

Job Opening - Records Specialist in Roche Pharmaceuticals, Palo A lto

From:

"Shah-Kasturi, Haripriya {PDRO~Palo Alto}" <[log in to unmask]>

Reply-To:

Records Management Program <[log in to unmask]>

Date:

Wed, 24 Jan 2001 10:28:37 -0800

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (71 lines)

Senior/Regulatory Archivist (Records Specialist)

With our established product line and a healthy pipeline of innovative
products, Roche Pharmaceuticals is well positioned to move into the future.
Additionally, Roche has one of the best salary and benefits package in the
area.  If you want to work in a dynamic, challenging environment that
capitalizes on your strengths and abilities, consider the following career
opportunity at our Palo Alto campus.

The Regulatory Archivist position maintains the regulatory records from the
creation of the record till its ultimate disposition when the retention
period of the record expires.  The position is responsible for all aspects
of records management for the regulatory submissions, emails, incoming
correspondence from the FDA, and other documents that form a part of the
history of the development candidate or the marketed product.

Essential Functions/Duties:
1. Manage physical and electronic records according established guideline
2. Ensure compliance with established records retention schedules
3. Perform quality check on records received
4. Communicate proactively with the supplier of records
5. Classify and index records according to predefined criteria
6. Track records in appropriate systems/tracking tools
7. File physical records on shelves according to defined procedures
8. Retrieve records for customers in a timely manner
9. Provide information on availability of records and generate standard
reports
10. Maintain log for all records transferred to service providers in
appropriate systems/tracking tools
11. Prepare all records for microfilming and transfer to passive archive
12. Be the principal interface with service providers, both internal and
external
13. Maintain records in active and passive archives and also the microfilm
archive
14. Retrieve records from passive archive/external service providers and
microfilm archive as required by customers
15. Independently manage special projects as assigned by line manager

Knowledge/Skill Requirements:
1. AA degree or equivalent.  Education, training or experience as records
manager/archivist, librarian, medical documentation assistant or sufficient
working experience in the records management area
2. Demonstration of attention to detail, strong interpersonal and
coordination skills
3. Working knowledge of computer systems and good knowledge of standard MS
Office applications
4. Ability to function independently with minimal supervision
5. Knowledge of Function - Sufficient understanding of the drug development
processes and workflow
6. Responsiveness - provides timely and accurate responses to requests for
regulatory records and information.
7. Interpersonal Skills/Team Work - displays ability to work effectively
with other team members to achieve completion of tasks within aggressive
timeframes.
8. Planning and Organizing - manages own workflow and takes responsibility
for the quality of individual work.
9. Problem Solving Skills - pays attention to detail, solves basic problems,
and applies experience in solving problems of similar nature.
10. Customer Focus - deals effectively with customers by following through
on commitments and agreeing to realistic goals.
11. Demonstrates the ability to work under pressure multitask.
Independently able to organize and prioritize activities.

If you would like to explore this opportunity at Roche, write Attn: Jean
Archie and send your resume by
email to mailto:[log in to unmask]
Or, fax to (650) 424-8159
Or, mail to Roche Pharmaceuticals
Staffing, A2-HR
3401 Hillview Avenue
Palo Alto, CA 94304-1397

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