The Manager , Documentation & Compliance is responsible for documentation and compliance strategy and mapping the necessary steps to ensure compliance. This individual is responsible for compliance with documentation policies and processes within Nonclinical Development as well as training in Nonclinical Development.
This individual will champion good documentation practices and will work collaboratively with Research (R) and Nonclinical Development (NCD) scientific and operational staff, IT, R&D Compliance, and other relevant groups to deliver appropriate processes and tools (if appropriate) to meet this objective.
S/He will also manage all aspects of training within R and NCD as well as consult with R and NCD departments and subgroups on functional area compliance needs.
The responsibilities of the successful candidate are expected to evolve with the needs of the division. Initial responsibilities and estimate % of time include:
% of Time
Job Function and Description
- Represents R and NCD on documentation initiatives.
- Represents R and NCD at the Procedural Document Review Committee. (PDRC)
- Lead planning and cross-functional execution of Standard for Exchange of Nonclinical Data (SEND) in close collaboration with NCD and Regulatory functions
- Develops and maintains processes to ensure that Shire standards for documentation, document transfer, version control and archiving are applied within NCD and by external vendors.
Records & Information Management (RIM)
- Serve as the RIM Steward for NCD
- Lead NCD integration efforts related to the data and system of acquired assets and companies.
- Represent NCD on data mergers, system syncing and documentation requirements throughout process.
- Set migration plans and timelines for NCD functions to execute. Communicate updates and migration plans to constituent groups.
- Collaborate with Nonclincal Regulatory Submissions and Document Management to ensure training, resource and processes are in place for data archiving
- R&D Compliance & Training Network Manager for both Research and Nonclinical Development.
- Communicate monthly training compliance metrics to R and NCD LTs and analyze results on a quarterly basis to propose remedial action, as needed.
- Work with other R, NCD and R&D functions as well as non-R&D contacts and external parties to generate new trainings, as needed.
- Author controlled documents
- Participate in all internal audits associated with documentation and document management including input on the responses to audits. Level of participation to be determined by scope of audit.
Nonclinical Study Tracking
- Serve as the Business Owner for NCD’s Preclinical Information Management System (PIMS) and its related activities
- Oversee 1 Operations Associate wth responsibility for:
- account creation and deactivation within PIMS, as well as training new users
- consistency and excellence in data entries
- monitoring of any system-related issues that need to be escalated to IT
- identification and resolution, as appropriate, for system and/or practice improvements
- B.S. in a relevant discipline is required.
- At least 10 years experience working in the preclinical stage within the pharmaceutical industry.
- At least 5 years experience compiling preclinical documentation.
- Fluency in written and spoken English is required.
Location/Region: Lexington, MA