Reporting to the SVP, Research, the Senior Associate, Research provides support to research operations by coordinating meetings with internal and external parties, managing timelines, maintaining and reviewing documents and overseeing budgets.
• Oversees coordination of departmental activities by updating departmental trackers, project logs and time-lines. Generates Gantt charts and other tools to support timely execution and coordination of global research activities.
• Attends meetings scheduled by SVP, to provide documentation (minutes) and ensure all action items captured in appropriate logs. Coordinates and tracks follow-up activities to ensure project progress.
• Provides support with preparation of material (e.g. slides) for upcoming implementation and Steering Committee meetings, Research department meetings, etc.
• Provides oversight and input into the preparation of research related updates and documents.
• Under supervision of Principal Scientist, coordinates with CROs and research collaborators to maintain study time-lines, schedule meetings and manage communications as needed.
• Under supervision of Principal Scientist, reviews data from recent studies to ensure appropriateness, provides data management and tracking.
• Works closely with Clinical, Pre-Clinical and Program Management functions to ensure all required studies are designed and prepared on time for submissions (help coordinate timing between groups, maintain log of Research tasks if required).
• Serves as Research point person for receipt/supply of documentation from external vendors (data management).
• Under review as appropriate develop departmental processes and work instructions as required.
• Coordinates and manages logistics of Research department face-to-face meetings, advisory panel meetings, conferences and related activities.
• Tracks and manages departmental budget, coordinates with Finance department and ensures SVP and Principal Scientist are informed of budget status.
• Other related duties as assigned.
• Bachelor of Science in a Biology or a related discipline with a minimum of 5 years directly related experience in a regulated environment, or the equivalent combination of education and experience.
• Expert user of MS Word, Excel, Access with the capability of effectively working with large complex documents.
• Superior administrative skills and attention to detail.
• Proven ability to manage multiple simultaneous projects effectively.
• Strong technical/analytical skills to identify and solve problems.
• Working knowledge of drug development and commercialization processes, FDA/ICH/EMA guidelines and cGMPs.
• Ability to exercise independent judgment in making decisions to assure quality.
• Demonstrated project management experience and skills, with the ability to coordinate multiple projects in a demanding fast-paced environment.
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company, vendors and contract sites.