Position Title: / Submissions Specialist / SAP positioncode:
M05/E11 / Job Group:
Subgroup / SC: / Location:
Business Unit/Division: / Bayer Schering Pharma AG / Function / Department:
Jobholder: / Supervisor: / Asst Director, Global Submissions Management
prepared by: / Last change by:
Preparation date: / March 23, 2009 / Last changeon:
Reporting staff to this position
Resource reports:
Functional reports:
3rd party reports: / finalized on:
2. / Position purpose(A brief statement indicating the basic purpose of the position)
As an eSubmissions expert, the incumbent provides direct support to submission project teams, internal GRA stakeholders and all functional disciplines responsible for developing and delivering components for submissions (electronic, paper, ICH, non-ICH). Additionally, the incumbent performs hands-on daily submission compilation and publishing activities associated with preparation of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and global submission types. Incumbent is responsible for the overall quality of the assigned dossiers which must comply with all internal Bayer best practices, meet global regulatory requirements, and facilitate the review and timely approval by appropriate regulatory authorities. As part of the submission compilation process, coordinates the technical review / technical improvement and verification of the eCTD compliance of dossier-relevant R&D documents/reports.
3. / Major tasks and responsibilities of position(max. 8key topics)
The Incumbent executes all operational activities associated with compilation, publishing and distribution of submission dossiers for new and lifecycle management projects submitted to local and/or global Health Authorities under the direct supervision of a Global Submissions Leader. As part of the submission compilation process, coordinates the technical review / technical improvement and verification of the eCTD compliance of dossier-relevant R&D documents/reports consistent with appropriate standards. This is achieved by enhancing the technical quality of submission relevant documents/reports and/or collaborating with authors. The individual is trained on relevant Health Authority requirements regarding (electronic) submissions and processes. Responsible for applying all global regulatory guidance and regulations associated with the technical assembly and publication of submissions (paper, electronic and/or non ICH formats) with oversight from a GSL and/or GSM&A management. Ensures achievement of submission milestone dates for assigned publishing support activities. Identifies and documents issues that risk the submission timelines and escalates the issues to the GSL and/or GSM&A management to recommend appropriate resolution.
4. / Value addedto the success of the company – what are the main objectives of the function?
The main objective of this function is to deliver technically compliant submission documents/reports, which contribute to the development of submissions that meet the technical requirements and standards set by relevant health authorities. This is accomplished via the technical review of components for eCTD submissions ensuring the components/documents/reports are technically compliant (including the technical improvement of legacy documents/reports not meeting requirements), assigning submissions components to the appropriate submission location, applying an appropriate level of necessary navigational aides (e.g. inter-hyperlinks, bookmarks), and validating the output with appropriate tools.
The SubmissionsSpecialist partners closely with Global Regulatory Affairs Managers/Liaisons, under the direct supervision of the Asst Director Global Submissions Management to ensure:
- overall technical content of the submission and the quality of the dossier meets the (navigational) requirements of the reviewing health authority and is in alignment with established global business objectives
- format meets all regulatory requirements globally as well as the country in which it is being submitted
- technical life-cycle maintenance of dossiers
- overall technical content of the submission and the quality of the dossier meets the (navigational) requirements of the reviewing health authority and is in alignment with established global business objectives
- format meets all regulatory requirements globally as well as the country in which it is being submitted
- technical life-cycle maintenance of dossiers
5. / Contribution context:
Individual Contributorothers:
Team Member
Team Leader
Supervisor
Manage Supervisors
Manage Function/Department
6. / Work relations
(List the most important work relationships with internal and external partners/customers)
The position functions under the direct supervision of the GSL and/or GSM&A management. The critical business partners associated with the compilation of dossiers and thus interaction with Global Submissions includes specific authors, GRA, and support staff within Global Development and in some instances GDD. All interaction is usually accomplished via the GSL. Additionally, the use of publishing applications is an essential aspect of the submission creation process and thus requires communication and developing and maintaining a strong relationship among internal and external service providers (e.g. O&I, application vendors). The incumbent also responds to health authority inquiries specifically related to the technical merit of eCTD submissions.
7. / Qualifications
(Education, skills, experiences and personal characteristics necessary for success in this position)
BS or equivalent (degree preferred) in a life science or computer science and 1-2 yrs relevant experience.
Relevant experience may be met via a combination of electronic data/document management, project management, computer systems or publishing software support, electronic document publishing and/or regulatory affairs.
Knowledge of drug development process and relevant SOPs is required along with an understanding of federal regulations, international standards (e.g. ICH), and regulatory guidances as they pertain to the development and filing of e-submissons. The ability to interpret implications of these regulations, apply them to daily operations and to respond appropriately to questions from peers and cross functional professional staff is imperative.
Must have an excellent working knowledge of word processing, document management, and desktop publishing software packages, including hands-on knowledge of various document types, authoring tools and file formats (such as MS office templates, PDF files, SAS program/transport files, XML program code, etc.). Additionally, previous experience with a document management or electronic publishing tools is needed (such as PDF Fusion, EZsubs, Core Dossier, ISI Toolbox, Docubridge etc.). Must have an excellent working knowledge of databases and data structures (such as Lotus Notes databases, Oracle IMPACT, MS Access, SAS, etc.).
Strong communication and interpersonal skills are needed to interact with global document authors and their support staff across international Bayer sites and across different functional departments. Multi-cultural sensitivity gained from some direct international experience is highly recommended
Exposure to the project management function, tools and techniques as they apply to Regulatory submission projects is highly desirable. Self-motivation, a sense of urgency, attention to detail, sound judgement, and good follow-through are also essential.
8. / Key figures
(operating Budget, Turnover, Purchasing Volume, Project Cost, etc.)
- relevant financial figure of superior positionwhich figure? / No own budget
amount (Mio. € per year)?
- this position
Is this position responsible for a specific financial figure? / Yes / No
which figure?
If yes, specify amount (Mio. € per year)?
If no, specify which part of financial figure of superior position can be allocated (Mio. € per year):
9. / Organization chart
Signatures
Proposer, date
/ Approver (next level superior), date
Result of position evaluation by HRO-COR: / Date of last position evaluation:
Contact info: Kelly GUO: 13910519023；010-59271344
Email:
Email Title Model: Location-Position-Name- Gender-Degree-Specialized field
(例如：北京-Clinical Specialist-王小燕-女-硕士-生化)