You’re driven, resourceful, and above all else - remarkably smart.
You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.
Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developedand commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 23,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.
Directs and oversees all regulatory aspects of nonclinical and clinical product development including, but not limited to, preparing and reviewing regulatory submissions (such as development plans, gap analyses, INDs, NDAs/BLAs, IMPDs, CTD, eCTDs), assisting executive management with the administration of the Global Regulatory Consulting Department, developing work flow, and regulatory records document processes. Responsible for the management and development of the regulatory management team and staff. Interacts with senior management and staff on operational procedures and processes within the Regulatory department to ensure compliance.
- Provides strategic and tactical regulatory guidance relating to global drug development as subject matter expert for nonclinical and clinical development.
- Authors and facilitates communication with staff, subject experts, medical writers, project managers, and team members with respect to technical sections of regulatory documents. Provides regulatory review guidance. Helps to resolve any sponsor/investigator issues with regard to technical and non-technical issues.
- Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, 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. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
- Ensures Standard Operating Procedures are followed for adequate completion of regulatory documents. Reviews and approves guidelines for document preparation. Ensures regulatory documents are accurate and current.
- Leads/attends project staff meetings, project team meetings, clinical committees, and clinical training sessions.
- Provides timely, accurate information to business management staff regarding hours to be budgeted for assigned regulatory tasks for Requests-for-Proposal (RFP). Reviews RFPs and budgeted hours for regulatory deliverables and forwards issues to the Project Manager or Functional Manager. Periodically reviews project expenditures for compliance with budgets for assigned tasks.
- Interacts directly with customers and potential customers to explain regulations surrounding assigned regulatory functions; reviews processes and factors affecting project cost estimates.
- Contributes to regulatory affairs process improvement efforts. Leads meetings to discuss current and future activities of the department.
- Maintains overall awareness in the field of drug development, as well as applicable regulatory requirements, by reading related literature, attending training classes, attending professional meetings, etc. Conducts continuing education sessions, presenting information gathered from off-site conferences to coworkers.
- PhD in a scientific discipline or equivalent combined education and experience preferred.
- Extensive clinical research experience and significant supervisory and/or project management experience.
- Demonstrated expertise in at least one area of clinical product development: chemistry, manufacturing, and controls development, nonclinical development, or clinical development.
- Experience or familiarity with document preparation and/or publishing systems preferred. Knowledge of procedures for reporting nonclinical and/or clinical study data.
- Extensive knowledge of FDA regulations and medical terminology. Strong organizational, presentation, documentation, and interpersonal skills as well as a team-oriented approach.
- Proficiency in Microsoft Office Suite and email. Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Make your work matter everywhere. Be a driving force in a rapidly evolving healthcare industry.
Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled).