Senior / Director, Regulatory Pre-award Strategy - US / Europe - Remote

Senior / Director, Regulatory Pre-award Strategy - US / Europe - Remote

3 days ago Be among the first 25 applicants.

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

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 The Regulatory Pre-award Strategy Director Does At Worldwide

This is a leadership role, accountable for directing business development and pre‑award activities, developing them into compelling and competitive proposal offerings leading to bid defenses. Pre‑award activities include designing and driving regulatory strategies, overseeing proposal development and approving pre‑award deliverables. The role also requires designing and implementing a department‑wide business development training and coaching program for various roles within the department.

What You Will Do

• Have and apply knowledge of global start‑up and regulatory activities to pre‑award customer deliverables, resulting in a differentiated advantage for bid defence and award
• Attend and provide leadership in bid defence meetings and presentations
• Collaborate with Regulatory team leadership, Therapeutic Area leadership, Business Development, Project Management, Site Management and other functions to develop comprehensive pre‑award site activation strategies
• Develop and implement a comprehensive department‑wide training and coaching program in collaboration with internal stakeholders
• Train and coach department team members on pre‑award activities to expand pre‑award skills and increase flexibility when assigning qualified resources to pre‑award work
• Achieve operational and financial performance targets related to proposal budgets and strategies
• Provide department resource projections and coordinate with the resourcing team to ensure pre‑award staffing plans and forecasts are accurate and adequate
• Proactively interact cross‑organisationally to develop and learn about emerging business, regulatory, therapeutic, and operational strategies that improve service to our internal and external customers
• Instill confidence in our customers during the proposal and bid process through knowledgeable and accurate communication of our startup strategy, including global / country regulatory requirements
• May help develop and implement cross‑functional initiatives for continuous process and quality improvements
• May have line management responsibilities

What You Will Bring To The Role

Your Experience

We love knowing that someone is going to have a better life because of the work we do.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, colour, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status or other classes protected by applicable law.

Seniority Level

Director

Employment Type

Full-time

Job Function

Legal

Industries

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