Associate Director, Regulatory Affairs - Publishing (REMOTE BASED)

Posted 4 days ago United States Salary undisclosed
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Job Description

Summarized Purpose:Manages a large, regional and/or global team of staff and managers within the department and provides innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization. Manages projects and participates in strategic initiatives. Acts as liaison with internal and external clients in the provision and marketing of regulatory services.Will be responsible for process improvement, resourcing, assessing deliverables and oversight of the publishing group.Essential Functions:Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards.Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products. Provides project specific strategy, technical expertise and coordination oversight for key client's projects. Serves as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensures quality performance for key/managed projectsManages project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget. Leads and participates in project meetings.Ensures identification of out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modification.Collaborates with business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD.Contributes to development and implementation of global/regional function/plans.Ensures compliance with relevant organizational and department SOPs and WPDsCreates and leads the development and implementation of processes and procedures to increase productivity and accuracy within the team. Participates in developing and implementing systems and tools to continually improve efficiency of all activities supporting and facilitating process improvements,reduction in cycle times, submission activities, metrics and other key performance indicators.Qualifications:Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) .5+ years of management responsibilityProven leadership skillsIn 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 roleKnowledge, Skills and Abilities:Effective English language communication and negotiation skills, as well as local language where applicable, both oral and writtenIn-depth understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle managementBroad understanding of ICH and other global regulatoryguidelinesAdvanced knowledge in publishing.Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skillsCapable of supervising, evaluating, and mentoring departmental personnelCapable of delegating tasks and facilitating the completion of assignmentsCapable of driving innovation in developing new ideas related to process improvementsComprehensive organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing prioritiesEffective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverablesCapable of independently learning new technologiesManagement Role:Directs through lower management levels and / or highly skilled specialist employees who exercise significant latitude and independent judgment. Often heads one or more departments or a large centralized staff function. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.)