Senior Regulatory Affairs Associate (French speaking)

We currently have an amazing home-based opportunity for a French speaking Senior Regulatory Affairs Associate to join our incredible team of global regulatory professionals!

If you have experience preparing and submitting Clinical Trial Applications (CTAs) to the French National Agency for Medicines and Health Products Safety (ANSM), enjoy client interaction, are experienced/have an interest in serving as a local Regulatory contact, and are seeking an opportunity with the potential to grow into a Regulatory Lead role, we would love to connect!

A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge of what services PC provides. A Senior Associate must be technically competent and continually developing the skills as defined in the responsibilities section of this document. A Senior Associate, under the general direction of a Project Lead and Technical SMEs, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. A Senior Associate may act in a client facing role with support from line management.

Key Accountabilities:

Project Execution

Works effectively within a team environment but may work independently delivering services within their area of competence

Works within broad project guidelines as directed by the project lead and/or technical SMEs

Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager

Capitalizes on opportunities to improve one’s own performance and seeks feedback from the project lead and colleagues

Applies information provided by the project lead or senior colleagues to complete assigned project activities

Produces quality work that meets the expectations of project lead and the client

May support the project lead with project management activities

Consulting Activities and Relationship Management

Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or technical SMEs

Delivers consulting services within personal area of expertise under the guidance of the project lead and technical SMEs

Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability under the direction of the project lead

Identifies project and internal issues to senior colleagues and Project Lead and provides proposed solutions

Interacts professionally at all working levels within a client organization and within Parexel

Identifies project and/or client needs to the project lead and collaborates with senior staff to define a proposed solution

Interactions result in clients expressing satisfaction with service provided

May assist in preparing and/ or delivering a presentation with the support of senior colleagues

Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope

Business Development

Continue to build a network of industry colleagues through relationships formed during project engagement or through other industry experience

Communicates potential new business lead to PC management and account managersQualificationsSkills:Client-focused approach to workResults orientationTeamwork and collaboration skillsExcellent interpersonal and intercultural communication skills, both written and verbalCritical thinking and problem-solving skillsBilingual with excellent written and oral communication skills in French and English

Knowledge and Experience:3-4 years of experience in an industry-related environment with previous experience with CTA submissionsEducation:Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline