Posted to MedZilla on 5/24/2017


Takeda Pharmaceuticals

US-MA, Records Operations Manager 1701185-MZ


 
 

OBJECTIVES:
  • Manage the centralized operational aspects of records management within an assigned Takeda location (Deerfield, London, etc.)
  • Manage the implementation of a comprehensive Records & Information Management Program within the assigned location, consistent with the Global Records Management Program and in compliance with all applicable company policies and procedures.
  • Manage projects related to records management as may be assigned due to business initiatives such as site closures, acquisitions, divestitures, audits, inspections, litigation

ACCOUNTABILITIES:

Global Records Program Management
  • Implement elements of the Global Records & Information Management (RIM) program as they apply specifically within the assigned location, including: Policy, Retention Schedules, Standard Operating Procedures, Training & Communications.
  • Participate in the further development and improvement of the Global RIM Program by providing input related to the assigned location, including policy, procedure, training, communications, systems development and overall program design.
Records Operations Management
  • Develop and maintain Records Filing/Archiving Agreements with functional areas/departments, assuring consistency across regions/locations where applicable. Assure any associated job aids (e.g. Format Guides) and Records Transmittal Forms are maintained in alignment with these agreements.
  • Manage the receipt, registration, scanning (as required), tracking, retrieval and disposition of paper and electronic documentation sent to Records Management for long-term preservation in the appropriate repository and/or in the on-site and off-site records collections
  • Maintain any local records management systems that are used for the above activities
  • Manage the local network of Records Management Liaisons (departmental subject matter experts) to ensure that each department is represented by a knowledgeable RML/SME.
  • Manage projects related to records transfers into/out of the company due to mergers, acquisitions, etc., and projects related to inspection readiness and litigation support
  • Undertake other duties appropriate to the post as required
Records Management Subject Matter Expert
  • Develop and implement processes, including training and communications, for the management of paper records and e-records, ensuring alignment with Global Policies and Procedures
  • Partner with internal functional groups to embed records management procedures in daily working practices
  • Participate in projects to develop and implement processes and standards to enable significant efficiencies in the management of key types of records (e.g., Trial Master File) in designated business applications, as well as the management of records and information in other electronic systems such as e-mail and Sharepoint sites.
Contract Management
  • Manage contracts with and oversee third party vendors to ensure compliance with agreed processes for the management, scanning, archiving and disposal of company records
  • Act as records management subject matter expert in other contract discussions as required e.g. Master Services Agreements.
Environmental Awareness
  • Maintain an expert, current knowledge of regulations, legislation, best practices and guidelines relating to records management.
Leadership
  • Responsible for the personal and professional development of the Records and Information Management organization based in the assigned location
  • Ensure the development of core competencies and measurement of performance (according to local procedures and any applicable national laws) against departmental goals and expectations
  • Prepare and monitor budgets for the group as appropriate
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Required:
  • Bachelor s degree
  • 7+ years direct records management/archiving experience along with 3-5 years experience with electronic document management
  • Solid understanding of records management and document management systems and concepts
  • Detailed understanding of the principles of good records management practices and its application to the pharmaceutical industry
  • Understanding of systems and electronic technologies used to support records management
  • Desired:
  • Master s Degree
  • Previous management of pharmaceutical records/archive facility
  • Previous development of records management programs including records retention schedules, policies, procedures, training programs, and communications
Skills:
  • Analytical and Problem Solving Skills- ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
  • Communication Skills- ability to express one s self clearly and concisely to customers over the phone or with others within team; documents issues and/or concerns concisely and comprehensively
  • Interpersonal Flexibility- ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
  • Knowledge Sharing- ability to capture knowledge within the organization; improve solutions, processes and deliverables through use of information; improve information capital by contributing experience, theories, deliverables and models for others to use. Shares information with staff as confidentiality allows
  • Change Management ability to identify, advocate and implement change positively for the organization
  • Teamwork- the ability to work well in a highly cross-functional and global team environment
  • Leadership Skills- develops, uses and shares knowledge and uses strong interpersonal skills to influence and guide others (both inside and outside the department) towards the accomplishment of Takeda s goals and objectives
  • Strategic Approach - identify, create and implement processes for Records Management that satisfy R and D and Takeda needs
Knowledge:
  • Records Management-understands the principles and practices of records management such as those defined/described in ISO Standards and the Generally Accepted Record-Keeping Principles published by ARMA International
  • Clinical Development-understands the phases, processes and techniques used within a clinical development environment
  • GxP-understands and applies record-keeping requirements and industry standards as outlined in good clinical practices, good laboratory practices, good pharmacovigilance practices, good manufacturing practices
  • Takeda Operations-understands (or capable of understanding) Takeda s operating structure and methods including a good knowledge of the parent company
  • Understands ICH guidelines and Good Clinical Practice/Good Manufacturing Practice Guidelines. Has an understanding of the regulatory submission process.
  • Advanced skills using MSExcel, MSWord and intermediate-advanced level skills using PowerPoint

LICENSES/CERTIFICATIONS:
  • None required; CRM is desirable
PHYSICAL DEMANDS:
  • Significant amount of sitting and using a computer.
  • Job requires use of hands and arms, finger dexterity and good hand/eye coordination to reach, write, type, and operate computers and peripheral devices (desktop scanners, printers, photocopy machines, hand-held barcode scanners and similar technical equipment)
  • Job requires periodic, and sometimes significant, combinations of physical activities including standing, walking, bending, stooping and reaching to file/retrieve files or boxes, pushing/pulling carts containing files or boxes
  • Job requires occasional lifting boxes of records weighing up to 40 lbs.

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings or company sites, including overnight trips. Some international travel may be required.
  • Requires approximately 5 % travel.

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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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