Medpace Work Values

Daily Duties at Medpace:

Interact with clients as single point of contact for regulatory projects to manage collaboration and client expectations. Create project timelines and manage work to meet those timelines, ensuring quality deliverables. Provide input to client regarding regulatory strategy and options available to accomplish client's business and regulatory goals. Interact with FDA and other regulatory agencies as required to attain the best possible regulatory outcome for the client. Manage direct reports and contractors on a project basis. Review direct report performance, recommend advancements and compensation increases. Work with direct reports to develop a career development plan that encompasses their personal and professional goals and meets business needs. Assess project scope and cost on client RFPs, develop and conduct bid defenses, and liaison with clients to explain document processes and negotiate contract terms. Lead department-wide initiatives to standardize processes, assessing processes and implementing improvements to maximize quality and efficiency. Represent department on company-wide initiatives.

What they like about Medpace:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Regulatory Affairs, home based, PharmD, Word, Acrobat, Excel, eCTDXpress, OTCs, Medical Writing, Regulatory Strategy, Manager, Pharmaceuticals, Generics, INDs, NDAs, ANDAs, Clinical Development, clinical trial design, regulatory submissions, Phase 1-4, labeling, advertising, promotional materials, global, cross-functional team leader, ISI Toolbox, Documentum

Skills

regulatory strategy, regulatory submissions, communication, oral and written, people management, project management, medical writing, clinical trial design, protocol development, collaboration, creative problem solving, decision making, analytical assessment, MS Word, Adobe Acrobat, ISI Toolbox, eCTDXpress, MS Project, MS Powerpoint, Excel, Sharepoint, Documentum, grace under pressure, multitasking

These are some of the questions we asked our climbers about their experiences with Medpace: