Information Governance & Compliance Analyst

Pharmaceutical Product Development (PPD)

PH-PH-Taguig City-Taguig City PH 5th Avenue


Summarized Purpose Develops, interprets and implements information governance concepts to ensure compliance with legal, regulatory, and operational requirements. Serves as go-to person on information governance to PPD functional groups. Performs basic analysis to determine present and future requirements associated with information governance within PPD. Gathers, analyzes, prepares and summarizes recommendations for information governance-related activities. Researches and assists in implementation of processes in the areas of information governance including but not limited to: record retention, eDiscovery, legal holds, Electronic Trial Master File (eTMF), and/or data archival. Captures, monitors, analyzes, and provides metrics on a scheduled basis to ensure quality in the information governance program. Essential Functions:

• Gathers, analyzes, summarizes, and develops recommendations for information governance-related activities.

• Researches, develops process documentation, and leads/supports the implementation of piloted processes in the areas of information governance, including but not limited to: record retention, eDiscovery, legal holds, Electronic Trial Master File (eTMF), and/or data archival.

• Creates, monitors, analyzes, and provides metrics, inclusive of issue resolution, on a scheduled basis to ensure quality in the information governance program.

• Develops and supports ongoing enhancements to IGC processes, systems, training, communications, and/or software applications.

• Pilots and supports the integration of IGC processes with other functional areas.

• Provides Tier 2 support on IGC-related issues.

• Researches, recommends, and implements quality programs, processes, and procedures that comply with global regulations, laws, and PPD policies.

• Supports IGC change control and impact analysis process. Summarized Purpose Develops, interprets and implements information governance concepts to ensure compliance with legal, regulatory, and operational requirements. Serves as go-to person on information governance to PPD functional groups. Performs basic analysis to determine present and future requirements associated with information governance within PPD. Gathers, analyzes, prepares and summarizes recommendations for information governance-related activities. Researches and assists in implementation of processes in the areas of information governance including but not limited to: record retention, eDiscovery, legal holds, Electronic Trial Master File (eTMF), and/or data archival. Captures, monitors, analyzes, and provides metrics on a scheduled basis to ensure quality in the information governance program. Essential Functions:

• Gathers, analyzes, summarizes, and develops recommendations for information governance-related activities.

• Researches, develops process documentation, and leads/supports the implementation of piloted processes in the areas of information governance, including but not limited to: record retention, eDiscovery, legal holds, Electronic Trial Master File (eTMF), and/or data archival.

• Creates, monitors, analyzes, and provides metrics, inclusive of issue resolution, on a scheduled basis to ensure quality in the information governance program.

• Develops and supports ongoing enhancements to IGC processes, systems, training, communications, and/or software applications.

• Pilots and supports the integration of IGC processes with other functional areas.

• Provides Tier 2 support on IGC-related issues.

• Researches, recommends, and implements quality programs, processes, and procedures that comply with global regulations, laws, and PPD policies.

• Supports IGC change control and impact analysis process.

Education and Experience: Bachelor's degree and 2-5 years of information governance and compliance relations experience. 1 to 2 years’ experience using eTMF systems such as VEEVA Vault eTMF or similar eTMF platform a plus. Strong MS Excel Skills is an advantage

In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Good computer skills with the ability to learn appropriate software/hardware

• Good Microsoft Office user

• Basic Livelink or similar content management system user

• Strong attention to detail

• Good problem-solving abilities

• Good organizational and time management skills

• Excellent oral and written communication skills

• Familiarity with records management principles including but not limited to retention schedules, RM classifications plans, generally accepted recordkeeping principles, and legal holds AND/OR

• Familiarity with taxonomies (e.g. folder structures, metadata, user access) AND/OR

• Familiarity with eTMF process and structure AND the DIA eTMF reference model AND/OR

• Familiarity with archival processes and systems

Education and Experience: Bachelor's degree and 2-5 years of information governance and compliance relations experience. 1 to 2 years’ experience using eTMF systems such as VEEVA Vault eTMF or similar eTMF platform a plus. Strong MS Excel Skills is an advantage

In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Good computer skills with the ability to learn appropriate software/hardware

• Good Microsoft Office user

• Basic Livelink or similar content management system user

• Strong attention to detail

• Good problem-solving abilities

• Good organizational and time management skills

• Excellent oral and written communication skills

• Familiarity with records management principles including but not limited to retention schedules, RM classifications plans, generally accepted recordkeeping principles, and legal holds AND/OR

• Familiarity with taxonomies (e.g. folder structures, metadata, user access) AND/OR

• Familiarity with eTMF process and structure AND the DIA eTMF reference model AND/OR

• Familiarity with archival processes and systems


2021-03-31 00:00:00


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