Senior Consultant - Regulatory Affairs Generalist
Parexel International Corporation
USA - Any Region - Home Based
Tremendous home-based opportunity for a General Regulatory Affairs Senior Consultant to join Parexel's highly recognized Regulatory Consulting Team!
A Senior Consultant must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, profound knowledge within a business context of what services PC (Parexel Consulting) provides. A Senior Consultant develops specialist knowledge of a particular subject matter or market. Provides a broad range of consulting services and works within broad project guidelines to identify, refine, and address client issues and to achieve project objectives.Provides guidance to project team members on technical/process issuesEnsures the timely performance of work within a project scope to the quality expectations of PC and the clientAnticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.
Project ExecutionWorks within a team environment or individually based on the project needsWorks within broad project guidelines and facilitates issue and conflict resolutionsPrioritizes own work load and may prioritize the work load of the project team in order to achieve the project scopeCapitalizes on opportunities to improve project efficiency, results or team performance and proactively takes actionLeverages information from previous projects or other client work to complete assigned project activities as well as facilitate business decisionsProduces quality work that meets the expectations of PC (Parexel Consulting) and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are metManages small projects and may manage larger project engagementsInteracts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project supportProvides guidance to project team members, and acts as a mentor to junior staff
Consulting Activities and Relationship ManagementDemonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvementsProvides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clearCompletes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfactionFacilitates client decision making by framing issues, presenting options and providing objective business adviceCollaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activitiesActs as a trusted advisor to clients and/or project team on technical and/or process issuesDevelops business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry driversInteracts professionally at multiple levels including senior management within a client organizationSuccessfully penetrates executive management levels or other business units within a client organizationFacilitates the clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problemsDelivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referralsIdentifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account managementQualificationsWe are looking for individuals that have: 10+ years’ experience in an industry-related environment; Pharmaceutical/Biotechnology, CRO, or Life Science Consulting industries10+ years of experience in General Regulatory Affairs with previous experience reviewing and/or writing sections of IND and/or NDA applications from a clinical, nonclinical, or CMC regulatory perspectivePrevious small molecule experience is required Familiarity/experience with FDA interactions is required Experience with project lifecycle and management
Education - Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree Preferred
Language Skills - At least fluent vocal and written English
Travel Required - 30% Domestic or International EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.