North America Head of Regulatory Consulting

Updated: November 13, 2018
Location: Raleigh, NC, United States
Job ID: 1937

Overview

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.

Responsibilities

This opportunity is with Syneos Health Consulting, an industry-leading consulting firm specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You’ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop achievable strategies for our clients. High-level details in one sentence about the role. More specifically:

The successful candidate will focus on customer relations, business development, and marketing of the Company’s regulatory consulting services, both internally and externally He/she will develop and mentor managers and provide leadership to the Company via participation on various governance committees, integrated solution development initiatives, and cross business unit account plans He/she will be responsible for all employee issues, administrative functions, and budgetary responsibilities related to the North American regulatory consulting team. Travel to current and prospective sponsor sites and Company global offices.

 

Essential Functions:

  • Develops and implements strong customer-focused business/marketing plans and establishes partnerships with customers.  Builds new business through customer contacts and sales calls. Develops strong relationships with current and prospective clients to generate new and/or add-on business.

  • Provides strategic leadership to achieve the Company’s mission and department goals, creating value for customers.

  • Provides corporate leadership through participation on the Company’s governance committees and, collaboration across Syneos Health businesses and teams to ensure Regulatory Affairs is contributing to joint solutions, support our vision and mission and consistent with our corporate values.

  • 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.

  • Identifies the need and establishes consulting locations at other sites in order to ensure the proper geographical coverage of services.

  • Defines, develops, and implements global standards, procedures, and protocols and evaluates processes and services against those standards.

  • Prepares and maintains department budgets.  Monitors utilization and expenditures to ensure staffing is appropriate for work required and that fiscal goals are met.

  • Prepares the organization for new or changing regulations that effect the Company’s CCO or CRO efforts.

  • Communicates regularly with other members of corporate management structure.

  • Through publications and presentations, builds recognition of the Company’s expertise in the Regulatory Affairs and Product Development Strategy.

  • Performs other work-related duties as assigned.  

  • Moderate travel may be required (up to 50%).

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

  • PhD in a scientific discipline or equivalent combined education and experience.

  • Extensive clinical development and/or pharmaceutical industries experience.

  • Extensive leadership experience in global drug development and regulatory affairs.  

  • Moderate experience in clinical research.

  • Demonstrated success in business development activities related to regulatory affairs consulting

  • Demonstrated expertise in several areas of clinical product development: chemistry, manufacturing, and controls development, non-clinical development, or clinical development.  

  • Extensive knowledge of FDA regulations and medical terminology.  

  • Leadership skills to provide direction to, and foster teamwork across, numerous projects operating out of regional office and the corporate functional areas.  

  • Strong leadership and organizational skills to manage the departments profitably while focusing on the customers’ needs.

  • Managerial skills to develop short and long range business plans, identify and implement effective workflow processes and procedures, and manage budget and work execution.  

  • Interpersonal skills to foster open communication.  

  • Ability to coach and develop others, and to act as a catalyst for positive change.  

Proficiency in Microsoft Office Suite and email.

  • The drive for self-development, the ability to collaborate, and an action-oriented work ethic

Full Syneos Health Consulting benefits which include:

  • Generous paid time off and company paid holidays
  • Domestic Partner Coverage for: medical, dental, vision, and voluntary life insurance
  • Medical – Cigna; Dental – Delta Dental; Vision - EyeMed
  • Company Match 401K - $0.50 per dollar up to 9% of salary
  • Eligible to participate in Employee Stock Purchase Plan
  • Flexible Spending Accounts: Health Care and Dependent Care
  • Company-paid Basic Term Life Insurance at 2x base salary
  • Optional Supplemental Term Life Insurance (100% employee paid): for employee, spouse/domestic partner, and children.
  • Company-paid Short and Long Term Disability
  • Optional Supplemental Short and Long Term Disability (100% employee paid): employee only
  • Employee Assistance Program
  • Referral bonuses
  • Dedicated training and support

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/Vets/Disabled)

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