Who We AreWe’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 WorldwideWe 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 WorldwideThis 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 DoHave and apply knowledge of global start-up and regulatory activities to pre-award customer deliverables, resulting in a differentiated advantage for bid defense and awardAttend and provide leadership in bid defense meetings and presentationsCollaborate with Regulatory team leadership, Therapeutic Area leadership, Business Development, Project Management, Site Management and other functions to develop comprehensive pre-award site activation strategiesDevelop and implement a comprehensive department-wide training and coaching program in collaboration with internal stakeholdersTrain and coach department team members on pre-award activities to expand pre-award skills and increase flexibility when assigning qualified resources to pre-award workAchieve operational and financial performance targets related to proposal budgets and strategiesProvide department resource projections and coordinate with the resourcing team to ensure pre-award staffing plans and forecasts are accurate and adequateProactively interact cross-organizationally to develop and learn about emerging business, regulatory, therapeutic, and operational strategies that improve service to our internal and external customersInstill confidence in our customers during the proposal and bid process through knowledgeable and accurate communication of our startup strategy, including global / country regulatory requirementsMay help develop and implement cross-functional initiatives for continuous process and quality improvementsMay have line management responsibilitiesWhat You Will Bring To The RoleDemonstrated strong ability to define, organize, and develop complex Regulatory Affairs strategies into effective customer deliverablesStrong ability to collaborate effectively among multiple functions and personalities to achieve organizational goalsDemonstrated strong experience in effectively persuading internal and external customers and engaging in difficult conversations with desired resultsDemonstrated ability to manage activities and people in ambiguous and time-sensitive situationsStrong experience in Regulatory Affairs is required, and experience with at least one cross-functional department, such as Regulatory Compliance, Feasibility, Site Management, Project Management, or Patient Recruitment, is preferredInterest and adaptability to drive innovative solutions for our customers, such as with decentralized clinical trials, remote and local home healthcare models, and direct-to-patient technologiesAptitude or proficiency in using and learning digital and software systemsYour ExperienceUniversity/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory, or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilitiesMinimum of twelve (12) years of global clinical pharmaceutical industry experience, including 3 years of demonstrated skills and competency in managing teams in a global environmentExperience in Regulatory Affairs in Pharma, CMC and/or Preclinical (Toxicology) knowledgeExperience in Scientific advisory support & briefing packages prepDeep knowledge of the US & Global regulatory landscape is a plusDemonstrated ability to inspire effective teamwork and motivate personnel within a matrix systemAvailable for domestic and international travel, including overnight staysValid passportFluent in local office language and in English, both written and verbalBroad knowledge of the drug development process and client needsWe 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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.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, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. 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