Regulatory Submission Manager

  • Location
    Whippany, New Jersey
  • Job type
    Contract/Temporary
  • Category
    Medical & Science - Regulatory


POSITION: Regulatory Submission Manager
LOCATION: Whippany, NJ (Zip 07981)
DURATION: 12 Months
PAY RATE: 54.00-56.95
HOURS: 40 hrs per week

**Must be eligible to work for any employer in the U.S. without sponsorship / no corp to corp or 3rd party contracting arrangement / Adecco W2 only.**


DEPARTMENT
Regulatory Submission Management and Planning (RSMP)

DESCRIPTION
As a central eSubmissions expert, incumbent provides direct support to global submission teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions in scope.

Incumbent manages all aspects of document workflows associated with submission authoring, review, compilation, publishing and transfer on Health Registration Submissions worldwide using specialized software tools (e.g. docuBridge, documentum).

Has increasing submission management/coordination responsibilities for projects assigned in close interaction with the supervisor.

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 international submission types. This role includes partnering with RSMP colleagues at other sites to work on concurrent submission outlines and/or global dossier activities.

Interprets and applies all global regulatory guidance/regulations regarding format and structure to global submissions worldwide.

Responsible for implementing and promoting global electronic submission processes and document reengineering initiatives across Bayer Pharma. In addition, the incumbent will be responsible for capturing corporate knowledge regarding global submission standards and best practices across drug projects, contributing to global harmonization and transferring that knowledge to new submission teams. Knowledge transfer will include contributions to process documentation, format standards development, document template development, technical/process training.

Responsible for testing and release of new software functionality, and implementation of strategic technology initiatives related to dossier publishing.


POSITION DUTIES & RESPONSIBILITIES
1. Compiles and publishes documents/dossiers of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and international submission types.

For projects assigned, 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. This includes partnering with GSM colleagues at other sites to work on concurrent submission outlines and/or global dossier activities.

2. Provides centralized expert support and guidance to global submission teams, internal RA stakeholders, cross-functional document authors, support staff, and publishers on the creation, preparation, tracking, publishing, QC/QA, and filing of Global submissions.
Has increasing submission management/coordination responsibilities for projects assigned in close interaction with the supervisor.

Works with submission team members to identify critical path of submission and then tracks all relevant dossier component deliverables as needed to assure timely submission of high quality dossiers.

Ensures achievement of submission milestone dates for assigned publishing support activities.
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.

Identifies and documents issues that risk the submission timelines and escalates the issues to management to recommend appropriate resolution.

3. Institutes and contributes to global harmonization of QA/QC policies and procedures for Global electronic submissions and associated workflow processes. Captures corporate knowledge regarding Global submission standards and best practices across drug projects and transfers that knowledge across project teams and disciplines (via process documentation, standards development, submission document template development, technical training and process training).

4. Develops, implements and maintains a comprehensive training curriculum associated with all aspects of the e-submission process. Acts as the Global Submissions functional area expert and lead trainer. Provides training of new and temporary Global Submissions staff as well as global project team members (cross-functional document authors).

5. Works with document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates. Works with internal stakeholders to maintain state-of-the-art e-submission authoring tools techniques (e.g. table captioning, document styles, cross-referencing, etc.). Monitors evolving agency regulations and assures Bayer submissions comply with all document/file formats and structures.

The position functions under the direct supervision of a Regulatory Submission Lead and/or Regulatory Submission Management. Incumbent must work well with other RSMP colleagues in a global network.

Interacts with RA-managers, GRT-members and cross-functional project team members responsible for authoring of submission documents and summaries and relevant business partners incl. R&D IT functions.

Interacts with Health Authorities and responds to inquiries specifically related to the technical merit of eCTD submissions.


REQUIREMENTS/PREFERENCES
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, IBH), 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 file rendering, SAS program/transport files, XML program code, etc.). Additionally, previous experience with a document management or electronic publishing tools is needed (such as ISI Toolbox, docuBridge etc., though docuBridge / documentum experience preferred). Must have an excellent working knowledge of databases and data structures (such as Lotus Notes databases, Oracle IMPACT, MS Access, SAS, etc.).

Excellent verbal and written communication skills as well as interpersonal skills are needed to interact with various levels of international document authors and support staff across all disciplines. Multi-cultural sensitivity gained from some direct international experience is highly recommended. Ability to read and speak English fluently is mandatory.

Solid project management skills, tools and techniques and the ability to apply these directly to managing Regulatory submission projects is mandatory. Self-motivation, a sense of urgency, attention to detail, sound judgement, and good follow-through are also essential.

Education Requirement(s):

Minimum of a high school diploma 14+ yrs of progressively increasing responsibilities and relevant experience. Alternatively, a Bachelor degree and 6+ yrs of progressively increasing responsibilities and relevant experience or a Master degree and 5+ yrs of progressively increasing responsibilities and relevant experience.


IMPORTANT: This position is being recruited for by Adecco’s National Recruitment Center, not your local Adecco Branch Office. To be considered for this position, you must use the “apply now” button to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position listed above. For other opportunities available at Adecco go to www.adeccousa.com.

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Reference number US_EN_2_022862_402586