Description
Link Technologies is seeking a qualified Submissions Process Expert for a 6-12 month contract position in New Castle, DE.
Job Responsibilities:
- Astute listening to Business Implementation Leads to introduce positive changes in process for system implementation.
- Subject Matter Expert in end to end regulatory process for submission publishing, registration, and submission tracking.
- Collaborative working with IS Delivery work stream, Business Leads, and all members of the system execute team.
- Identify conditions necessary for the preparedness of system solution for publishing and submission and registration tracking for all life cycle aspects of a product.
- Assure cross-functional alignment of processes and information flow.
- Define scenarios and opportunities to test Process and process options and define regulatory compliance tracking.
- Work with Quality Assurance (QA) to define compliance and address gaps and issues
- Communicate the submission and registration tracking and publishing process.
- Identify gaps and inefficiencies, while mitigating issues.
- Align with the IS Work stream business analysis to articulate and map requirements to process.
- Identify gaps where system cannot support the process, risk of gaps, and how they will be addressed.
- Provide a fresh and unbiased perspective to lean process for system submission and tracking process.
- Incumbent must be able to map requirements to process to system solution and identify and communicate gaps in requirements.
- Define system model for submission tracking, registration tracking.
- Assess the level of centralized versus functional detail required of the process.
- Migration strategy for system as a type of submission.
- Present options for organization to better align with information/process.
- Assure compatibility with content information process.
- Define and communicate the implementation of submission and registration tracking for Marketing company and agents.
- Prepare comprehensive procedural documentation for the final system process for submission publishing and tracking.
- Define and communicate a clearly streamlined publishing, submission, and tracking process for: alignment of Information Model, information model for outsourcing, Process of Alliances, Divestment, In-licensing/Externalization, Generics, and Independent of procedure. (MRP/DCP/CP/National).
Job Qualifications:
- Bachelor Degree or Masters associated with appropriate experience is preferred.
To apply, please send your Resume in MS Word format and reference Job ID # 5223. We look forward to working with you!