Project Director Global Regulatory Affairs Solutions

hace 3 semanas

Barcelona, España Syneos Health Clinical A tiempo completo

**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 port

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