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Biopharmaceutical Solutions Executive
1 week ago
About Us
Syneos Health is a leading organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our approach brings the customer and the patient to the center of everything that we do. We continuously look for ways to simplify and streamline our work to make us easier to work with and for.
We 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 about changing lives.
What Sets Us Apart
- We develop 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 take care of our people.
- We continuously build 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.
Job Responsibilities
- Ensure delivery of assigned work according to contracted scope, timeline and budget in accordance with Company's SOPs, GCP and ICH guidelines and all applicable regulations.
- Achieve operational and financial targets for assigned Segment through active participation in Risk Review Process and routine review of metrics and KPIs via available suite of dashboards and reports.
- Participate in governance meetings with customers (Steering Committees).
- Provide input into short- and long-term strategic planning for all aspects of Global Project Management organization's operations and growth. Interact with executive management and contribute operational input to other departments as appropriate.
- Evaluate quality standards and maintain over all areas of responsibility. Ensure adherence to CAPA and QI timelines and outcomes for assigned book of work.
- Contribute to resourcing strategy in relation to customer proposals (e.g., RFIs, RFPs) and support with key customer meetings related to new business capture (e.g., bid defense meetings).
- Participate in discussions with TA Head regarding annual forecast planning and adjustments to forecasts based on quarterly reporting for both the TA and the organization.
- Participate in strategic resourcing and prioritization of projects across the portfolio.
- Interact with senior management of sponsor companies, vendors and other groups to address operational risks and issues.
- Responsible for line management and mentoring of Project Delivery Leads within assigned Segment.
- Support implementation of enterprise-wide project management systems and tools. Serve as Change Management Champion.
- Represent the Company by attending industry meetings, speaking engagements, participating in booth exhibitions etc.
- Support development of SOPs and departmental processes, training, staffing requirements etc.
- Maintain deep knowledge of evolving trends related to therapeutic area, competitive landscape (e.g., standard of care) and drug development trends – in addition to strong understanding of the Company's breadth of service offerings.
Qualifications
What We Are Looking For
- Bachelor’s degree in life sciences, nursing degree or equivalent education plus extensive clinical research experience in contract research organization, pharmaceutical, or biotechnology company.
- Multiple years of project delivery oversight or demonstrated track record of strong project delivery oversight.
- Cross-functional project management experience within clinical trial industry is required. Pharma/CRO experience is required including client relationship management.
- Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures is necessary.
- Demonstrated proficiency with ICH/GCP guidelines.
- Proficiency in Microsoft Office Suite (Outlook, Teams, Word, Excel, PowerPoint etc.).
- Demonstrated ability to manage multiple tasks within dynamic projectized matrix team environment assuring project delivery on time and with quality.
- Strong presentation, documentation and interpersonal skills as well as team-oriented approach.