Development Business Analyst

Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) is focused on becoming a global leader in the research, development and commercialization of novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections.  Founded in 1992, Cubist is headquartered in Lexington, MA.  For more information please visit www.cubist.com

 

 Position Summary

This position serves as one of the main IBS point of contact for Cubist’s Clinical, Regulatory, Medical Affairs, and Quality Assurance/Quality Control departments.  The incumbent must be extremely familiar with FDA system validation requirements, including 21CFR Part 11, since the position will assist in validation execution activities. 

 

Responsibilities include, but are not limited to, defining and delivering IBS projects of high value within the supported departments;  project management for IBS projects in Clinical, Regulatory, Medical Affairs, QA and QC;  performing application maintenance;  supporting the computer system validation process for applications as needed;  and providing strategic input related to Cubist’s Clinical, Regulatory, Medical Affairs, QA and QC departments.

 

 Duties and Responsibilities

· Develop functional specifications for new applications or enhancements to existing applications.  Work with users to analyze current procedures and suggest revisions.

· Serve as Project Leader for new applications or upgrades to existing systems.

· Participate in the design of testing procedures and in the testing of new applications.  Assist in assessing validation requirements and managing validation deliverables.

· Investigate and resolve user problems.  Maintain communication between users and support staff to reach satisfactory resolution.

· Provide data analysis, statistics and reports.

· Participate in writing user documentation for new applications, developing training materials, and providing new user training.

· Work with other IBS Business Analysts to provide cross-functional information supporting the Development Department’s needs (i.e. financial tracking information, etc.).

· Lead vendor and third-party validation efforts and manage change control processes to support FDA compliance.

· Provide customer input and participation in one and three year IBS business and strategy development.

 Qualifications

· Bachelor’s degree in Computer Science or the Life Sciences required; graduate degree preferred.

· 5-7 years in a pharmaceutical or CRO environment in an IT, Clinical, QA or Regulatory role required.

· Prior experience in system development and deployment required.

· Prior experience in a validated and/or regulated environment required.

· Working knowledge of Windows OS, MS Office and UNIX required.

· Working knowledge of TCP/IP and related network protocols highly desirable.

· Excellent Project Management skills.

· Good oral and written communication skills.

· Training and/or experience in database management concepts.

· Familiarity with terminology and procedures applicable to clinical trial management, statistical analysis and quality systems.

 

 

Benefits

Our outstanding benefits package includes: 100% vesting in our 401K plan, choice of HMO/PPO medical plan, employee stock purchase program, dental, life and disability insurance, tuition reimbursement, flexible spending accounts and 3 weeks vacation. In addition, we have unique extras such as: on-site massage therapy, 12 holidays, 4 of which are floating, EAP benefit focusing on work life balance issues and frequent celebratory parties!

 

Search Firm Representatives:

 

Please Read Carefully.

Cubist is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Cubist via email, the Internet or directly to hiring managers at Cubist in any form without a valid written search agreement in place for that position will be deemed the sole property of Cubist, and no fee will be paid in the event the candidate is hired by Cubist as a result of the referral or through other means. Note: Any search agreement entered into prior with Cubist to January 2006 is hereinafter void.

Search firms are essential to the recruitment and staffing efforts at Cubist and we value the partnerships we have built with our preferred vendors. For this reason, Cubist has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Staffing Consultant at Cubist in placein order for a fee to be paid for any candidate referrals.