Project Director Global Regulatory Affairs Solutions

Job Description

Syneos Health  Kalisz Metropolitan Area Remote 

• Full-time · Director

About the job

Description

Here at Syneos Health we are currently recruiting for a Project Director Global Regulatory Affairs Solutions

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Responsibilities For This Role Are As Follows

• Manages relationships between the Company and Customers to ensure global project management and management of projects occurs according to the Customer’s and the Company’s contractual agreement. Ensures that studies progress according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.
• Serves as the supervisor for a GRAS project management, managing other project managers and coordinators as well as specific projects and programs. Facilitates communication between project teams and upper management. Acts as a liaison and facilitator between other operation departments within the Company for project related tasks and/or issues. Assists with planning and assigning resources within the department.
• Supports a global team covering all possible time zones where the Company currently performs business.
• Line management responsibilities for staff members. For direct and indirect reports, may participate and direct activities related to department staff operations such as interviewing and selection, professional development, performance management, and employee counseling and separations. Approves courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods.
• Reviews global project management plans and documents to ensure they are consistent and conform to the Company’s SOPs and Work Instructions (WIs).
• Maintains and evaluates project progress by overseeing the maintenance of timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports as well as functional area plans, to appropriate team members and senior management.
• Supports the Business Development Department by providing information on the Company’s Project Management capabilities. Presents Company capabilities as well as PM specific responsibilities at Customer proposal defense meetings where applicable.
• Oversee a portfolio or program of projects.
• Represent company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
• Ensures the Project is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations.
• Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
• Ensure and maintain client specific knowledge and expertise for the assigned portfolio.
• Apply project specific learning across assigned portfolio of projects.
• Lead and ensure consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
• May lead operational input to proposal development and pricing including proposed operations strategy
• Drive performance improvement, operational efficiencies and innovative strategies
• May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert

Qualifications

The ideal candidate will need the following experience / skills to be considered:

• BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience.
• Extensive project management experience in a contract research organization, pharmaceutical, or Biotechnology Company.
• Previous management, CRO, and specific line management experience.
• Demonstrated proficiency with budget management and reconciliation.
• Experience of transition management
• Thorough knowledge of Regulatory Affairs, FDA/ EMA regulations, drug development, and project management procedures advantageous. Demonstrated proficiency with ICH/GCP guidelines.
• Exceptional leadership, presentation, documentation, and interpersonal (emphasis on proactive leadership) skills as well as a team-oriented approach.
• Proficient computer skills in Word, Excel, PowerPoint, MS Project, email and internet.
• Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements, i.e. GPP
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Proficiency with full MS Office Applications, including MS Project
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Ability to travel as necessary (approximately 25%)

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability.