Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000 professionals spans 60 countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What You Will Do
Review study budgets and costing pertaining to contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements
Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff
What You Will Bring To The Role
Clearly, proven leadership and organizational management skills are essential attributes
Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
Excellent written and verbal communication skills to clearly and concisely present information
Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meeting
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
Your Experience
A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…
Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years’ experience within clinical research (e.g. CRA, Reg Affairs.)
Minimum 7 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience
Proficient in cross-cultural communication and proficient in both spoken and written English
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Research, Quality Assurance, and Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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