The primary purpose of this position is to perform scientific support for client facing proposal generation to facilitate rapid proposal development by acting as the point of contact and generator of “standard” responses. This includes initial development of proposal outlines, draft protocols, or other related financial information needed to assist in the costing process and financial review for standard inquiries at multiple company locations and maintenance of Proposal Outlines (client specific and Covance). Tasks will be performed in accordance with the appropriate guidance (e.g. company standards, GLP and regulatory guidelines) in a timely, efficient and quality manner. The position provides back up support for the Scientific Triage team and other proposal mangers. The role requires the incumbent to liaise with scientific support within Immunology & Immunotoxiciolgy (I&I) to gain knowledge of service line and available assays within the group to facilitate proposal development.
Essential Job Duties
- Gains knowledge of I&I service line and uses resources to Facilitate rapid proposal development by acting as the point of contact and generator of “standard” responses. These consist of the initial development of proposal outlines and draft protocols to assist in the costing process for standard inquiries.
- Assists the Scientific Proposal Manager and Client Managers with proposal development and management for all types of Safety Assessment I&I inquiries. May develop proposals independently with guidance from senior scientific and proposal managers, within the specified turnaround time.
- Is aware that there are regulatory requirements for general study types and regulatory guidance documents, and works with colleagues to ensure these are incorporated into responses. Gains familiarity with international regulatory requirements and serves as a resource for Study Direction staff and Client Services as needed.
- Initiates costing requests for proposals and protocols for I&I inquiries and provides clear cost quotation
- Serves as a liaison between Safety Assessment, Client Services/Business Development and other internal departments related to proposal management.
- Acts as the initial internal contact person for Client Services when inquiries come in requesting protocol development.
- Assists in the collation of materials to respond to Client Questionnaires and Requests for Information (RFI’s).
- Field queries from the Safety Assessment Triage group with outline preparation. Able to gather information for advising on the capabilities and available methods of the departments
- Seeks guidance from colleagues and Subject Matter Experts to enable acting as a resource for Client Services regarding study designs and regulatory constraints to determine minimum requirements for a given study type.
- Interacts with Resource Management and Client Managers by providing the necessary information to facilitate costing process to insure a clear cost quotation.
- Interacts with Safety Assessment personnel as needed for their assistance in the protocol development process.
- Assists with the proposal generation process in order to meet proposal turnaround time.
- May assist with the production and presentation of metrics and also handle data mining requests from available systems
- Assists with regional and global triage and tracking of I&I costing by working with resources and colleagues within the I&I group to provide the required information
- Assists with presentations for internal and external use as required.
- Performs other duties as assigned.
- BSc degree in related field. Experience may be substituted for education
- 2 years of experience in a related scientific support role
- 2nd shift role (2:30 PM to 11:30 PM)
- Good understanding of GLP and GxP
- Toxicology/I&I experience preferred
- Proficient in computer and software applications (Word, Excel, CMS, Peoplesoft etc)
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed