Work Schedule

Environmental Conditions

Job Description

Summarized Purpose: Coordinates and oversees contracted PV deliverables across multiple services (e.g., case processing, safety writing, signal detection, safety reporting, QPPV, etc.) for one or more projects. Responsible for overall project planning, maintenance, and close-out activities of assigned projects. Provides oversight and accountability of project financial health. Serves as primary point of contact for clients; works with senior management and functional teams to ensure client deliverables adhere to key performance indicators (i.e., quality, compliance, etc.).

Essential Functions and Other Job Information: Essential Functions  Monitors, evaluates, and proposes mitigation strategies surrounding risk to PV project deliverables and finances.  Key point of contact for client.  Accountable for project financial stewardship and negotiates options with the client for various increases in scope of work to drive healthy gross profit and revenue margins.  Drives timelines and tasks/deliverables across all PV functions  Prepares and leads operational/tactical/governance calls with client(s).  Coordinates and leads preparation and attendance in client audits/inspections.  Maintains effective communication and coordination with other functional groups concerning project topics/issues.  Oversees generation of project metrics (e.g., key performance indicators, volumes, etc.). 

Maintains budget/financial oversight of assigned project(s), working with applicable teams for contractual activities (i.e., change notification forms, contract modifications, renewals, etc.) for all PV services.  Responsible for presenting on internal financial and project review meetings.  Broad understanding of PV and regulatory requirements, along with contracted activities and project outputs.  Accountable for collaboration with all PV functions to ensure key performance indicators meet agreed targets.  Serves as a resource to other departmental managers and leads departmental initiatives. Job Complexity Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Job Knowledge Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau. Supervision Received Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead).

Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Business Frequent contacts with internal personnel and outside customer representatives at Relationships various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.

Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:  Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to relevant legislation/regulations/guidance, global SOPs and client expectations  Excellent written/ verbal communication skills with a strong command of English language and grammar; strong attention to detail and accuracy in organizational, analytical/problem solving and decision-making skills; strong customer focus and excellent interpersonal skills  Ability to identify project risks, effectively evaluate and develop robust risk mitigation  Ability to forecast resource and coordinate/drive on-time completion of project deliverables  Ability to successfully apply above skills, knowledge and abilities across a portfolio of PV projects  Broad understanding of PV along with working knowledge of the global regulatory requirements and the importance of procedural/process compliance  Proficient in Microsoft Office products Management Role: No management responsibility Working Conditions and Environment:  Work is performed in an office/ laboratory and/or a clinical environment.  Exposure to biological fluids with potential exposure to infectious organisms.  Exposure to electrical office equipment.  Personal protective equipment required such as protective eyewear, garments and gloves. Physical Requirements:  Ability to work in an upright and /or stationary position for 6-8 hours per day.  Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.  Frequent mobility required.  Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.