Job Summary:

Provide project management to the Toxicology team, maintaining timelines and facilitating adequate workflow through utilization of various databases. Provide operational management and accounting logistics both within the team and with studies placed at CROs. Hands-on monitoring and execution of nonclinical studies, partnering with project teams throughout the process of drug development, monitoring deliverables, managing communications with CROs and Supernus stakeholders.

Essential Duties & Responsibilities:

• Work closely in collaboration with supervisor and team - to meet corporate goals and objectives and be adaptable in a changing environment; bring-in new collaborative/business proposals to strengthen Supernus pipeline.
• Create and maintain project plans and documents (weekly/monthly update reports, budget tracking, and others as needed).
• Manages multiple projects simultaneously with minimal supervision.
• As a study monitor and in collaboration with team: reviews protocols and study reports ensuring presentation of data in report is accurate, supporting the conclusions.
• Facilitate data review and comparisons, as needed, utilizing excel and PowerPoint graphs, charts and presentations or other digital tools.
• Obtain study proposals, create cost and study design comparisons, negotiate proposal agreement language, milestone payments and budget with CROs.
• For each agreement maintain the status of agreement, budgets, payments, any amendments for the duration of the study, and communications with internal and external stakeholders.
• Track study supplies and coordinate shipments of test material to sites as needed.
• Organize and lead cross-functional project team meetings (agenda, scheduling on teams, presentation of slides during weekly internal meetings, meeting minutes, etc.). Providing updates on project status, follow-ups and tasks assigned.
• Assist team with collecting, tracking, and providing Regulatory Affairs with study related documentation.
• Serve as a point of contact between Quality Compliance department and CROs for vendor audits and completion of documentation required.
• Provide operational management, archival, and accounting logistics.

Supervisory Responsibilities:

• N/A

Knowledge & Other Qualifications:

• Graduate Degree in Life Sciences (Master's degree or PhD)
• Minimum 3+ years pharmaceutical industry experience
• Minimum 3+ years operations management experience
• Proficient with MS Word, Excel, PowerPoint, and Outlook
• Strong organizational skills, capable of study/timeline tracking
• Must be able to clearly articulate project needs and status to project team and other Supernus departments
• Able to independently interact with CROs: obtain proposals, finalize contracts, review and finalize protocols and reports
• Experience with nonclinical study-related logistics and accounting

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability of having an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions.

Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.