Support project teams in achieving objectives and milestones. Prepare detailed timelines, and document minutes and decisions of project teams. Provide input into strategic planning, budget administration, and critical path issues / solutions. Pro-actively identify issues that could delay a project or adversely affect the project budget and recommend appropriate action(s) to be taken. Support the assigned teams as necessary (including functioning as a Project Team Member or a Project Team Leader) to ensure projects and initiatives are on scope, on time, within budget, and of high quality.
Judgment / Decision Making:
May develop and implement initiatives, processes, and goals for the departmental / functional area within the overall area of responsibility. May recommend policies, methods, processes, and techniques for the business function based on change initiatives. Creates / conceptualizes new methods, techniques, and / or processes across job areas or functions.
Errors in judgment or failure to achieve objectives would typically result in noticeable program delays and considerable expenditure of resources to rectify.
Responsibilities for Contacts:
Frequent contact with directors across the Product Development organization.
Education & Experience:
Requires a BA/MA in biology, chemistry, nursing or equivalent with at least 5 (five) years of professional experience in a pharmaceutical or biotechnology environment. Experience in clinical/medical research and/or familiarity with transdermal delivery systems is highly desirable.
Working knowledge of FDA regulatory requirements is required. A working knowledge of basic financial accounting is preferred but not required. Proficient computer skills and good working knowledge of MS Word, Excel, PowerPoint and Project are required. Knowledge of good manufacturing practices, scientific methods, engineering methods, analytical methods and / or safety protocols is desirable.
Excellent oral and written communication skills are essential.
Majority of time spent in office environment, operating computer.
Visual acuity and manual dexterity required to operate computer and proofread documents