Top Biopharm company is currently looking to recruit a Senior contracts analyst to join a dynamic team who are based in Gaithersburg, Maryland. Company will provide a highly competitive remuneration package with a strong relocation offering for the right person. For the right candidates a remote working solution is also available for discussion.
The successful candidate will have a range of responsibilities that are outlined below:
Primary responsibilities will include working within the Medical Operations Resource Performance Management group as a Senior Contract Analyst responsible for managing the coordination, negotiation, and finalization of contracts, modifications, and task specification addenda for clinical trial-related and departmental outsourced services within company Medical Organization, and/or supervising staff to execute the same.
Duties include liaising with multiple Medical Organization personnel to assess contract and outsourcing needs; prepare, request, review, and negotiate scope and budget proposals from outside vendors; quantify and/or review specifications and determine pricing to reach agreement; review and analysis of existing contractual agreements and budgets for negotiation of large scope changes to programs; managing the contracts and outsourcing at a therapeutic area level, and/or extension of work as needed, among other duties. Will need to manage high volume of proposal and contract requests to keep to process and project timelines while coordinating with Medical Organization personnel from multiple departments, Legal Affairs and other divisions such as Strategic Sourcing, Regulatory Affairs and R&D.
Works independently on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results, with minimal or no direction or direct supervision. Utilizes a broad and highly functional knowledge of FDA regulatory requirements.
Major Duties and Responsibilities:
The successful applicant should have demonstrated experience and ability in clinical trial project contract budgeting and negotiation, working with a high level of autonomy, with minimal supervision and strategic direction. Additionally, the Sr. Contracts Analyst may have responsibility for oversight of contracts and outsourcing across a therapeutic area.
Will be responsible for coordinating the processing of contracts from the identification of need through execution, analysis and reporting. This individual will prepare reports and metrics relating to the contract process as needed.
Will assess and interact with vendors regarding requested services and contract-related issues as well as coordinate and participate in preferred vendor assessments.
Will perform other specialized functions, including the preparation of clinical trial-related reference budgets through the management and use of licensed or internal benchmarking databases and software.
Will also assist with ongoing improvements to and implementation of strategic trial insourcing/outsourcing tools, processes, procedures, guidance documents and/or work practice instructions. This individual will coordinate with Resource Performance Management, Medical Organization and/or other personnel on cross-functional projects and train/assist Medical Organization personnel with adherence to the contract negotiation process.
Will aide in the preparation and review of process instructions/SOPs as well as RFP and contract templates.
This individual will perform other duties as assigned.
Minimal qualifications include 6 years of experience in medical research in industry or equivalent experience, including at least 4 years each in two of the following: clinical trials management, RFP development and proposal analysis, or contract negotiation and finalization.
A Bachelor's degree or equivalent experience, including at least 4 years in clinical trials management, clinical RFP development and proposal analysis and/or contract negotiation and finalization.
Additional skills will include: Good interpersonal, communication (written and verbal), influencing and organizational skills; computer skills, including word processing and ability to travel as needed. Highly functional knowledge of FDA regulatory requirements.
Please note that the successful candidate may reside either in Cambridge, UK or Gaithersburg, MD and therefore, candidates from both locations will be considered.