Senior Global Document Management Specialist

.pre {white-space: pre-wrap;} Your tasks and responsibilities

 

The primary responsibilities of this role, Sr. Global Document Specialist, are to: 

 

  • Plan/delegate work assignments, give direction, and supervise the activities of the Global Document Management Specialist and technicians, clerical staff and other personnel assigned during Regulatory Affairs projects and priorities and peak work periods;
  • Insure data captured in database of global regulatory documentation meets all international standards of quality and accuracy and is completed within established timelines;
  • Train Regulatory Document Management/Archive staff and temporary employees in the highly technical skills required to maximize efficiency, accuracy and productivity of daily data management tasks;
  • Apply increasing knowledge of Bayer Legal documentation, agency regulations and guidelines to Archive documentation;
  • Maintain periodic maintenance of Document Management and Archive database to assure no interruptions in document compliance or ongoing availability;
  • Develop and maintain international document management standards associated with the processes, technical systems and structures in support of the eArchive;
  • Lead the cross functional expert working groups for establishing and maintaining procedures and methods for the transfer of documentation with pharmaceutical co-marketing partners;
  • Provide project leadership and project management/coordination responsibilities with role on "Global Archive Teams". Incumbent manages aspects of electronic document workflows, work practices, and document reengineering initiatives associated with document management, compilation, and distribution of data used by Bayer Legal and Regulatory Authorities worldwide using specialized software tools. This includes the maintenance and training associated with Bayer worldwide standards for document management;
  • Regularly interact with various levels of international colleagues and conducts cross functional training for professional staff using pre-established material on document authoring plus use of document management systems and international workflow processes;
  • Work closely with and assist medical writing with regards to MRR publishing;
  • Supervise and verify the compilation of reports which includes an internal technical review of the published result according to the current regulatory requirements;

 

 

.pre {white-space: pre-wrap;} Who you are

 

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • Bachelor’s Degree with a minimum of four (4) years of Pharmaceutical regulatory document/records management experience;
  • Experience must include strong technical/IT database knowledge which includes hands on knowledge of various document types, and file formats such as MS templates, PDF file rendering, and program/transport files;
  • The incumbent reports directly to the Deputy Director, Global Document Management and works independently within the framework of Regulatory Projects;
  • Incumbent is responsible for the completeness, accuracy, and integrity of database and insures all documents comply with the SOPs and guidelines and that all inconsistencies have been resolved and can be produced for potential regulatory agency audits, due diligence, and legal projects;
  • Substitute for Deputy Director at meetings to provide input and comments and record results of decisions made. Incumbent has daily contact with global colleagues;
  • Incumbent has ability to travel internationally.
.pre {white-space: pre-wrap;} Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.