Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

This entry level role can be either office based in Vilniaus or you can be part home based in Lithuania. The office is open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world.

As the Junior Regulatory Affairs Associate you will assist in the production of submissions and delivery of regulatory services inaccordance with defined agency guidelines while balancing the quality and timeliness of customerdeliverables. You must be technically competent and continually developing the skills asdefined in the responsibilities section of this document. You will also under the general direction of aProject Lead, take responsibility for ensuring that client work is performed, and delivered on time, meetingthe quality expectations of Regulatory Outsourcing Services and the client. The guidance of more seniorstaff may be needed to accomplish more complex tasks and you will continually develop through to more experienced levels over time.

Key Accountabilities:

Project Administration
- Under supervision provide basic paper and electronic publishing servicesincluding document preparation, legacy conversion, scanning, rendering,bookmarking, hyperlinking, compilation, table of contents creation,volumization, pagination, and formatting of reports and simplesubmissions.
- Provide basic regulatory affairs services including preparing submissionpackages Capitalizes on opportunities to improve project efficiency, resultsor team performance and proactively takes action

DocumentManagement
- Under supervision perform basic document management tasks includingfile transfer, storage, tracking, and archival.

Regulatory Guidelines
- Develop a familiarity with current global regulatory submission standards.

Standard OperatingProcedures
- Develop a familiarity with departmental standard operating procedures andwork instructions.

Product Support
- (Regulatory Affairs only) Under supervision provide support to currentlymarketed products

Education:
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

Skills:

Project Execution
- Works effectively within a team environment.
- Works within broad project guidelines as directed by the project Technical Lead or Project Manager.
- With the guidance of the project Technical Lead or Project Manager, demonstrates the ability to prioritizework to achieve specified project outcomes.
- Capitalizes on opportunities to improve performance and seeks feedback from the project Team Leadand colleagues.
- Applies information provided by the project Team Lead or senior colleagues to complete assignedproject activities.
- Produces quality work that meets the expectations of Project Lead and the client.

Relationship Management
- Completes assigned activities within project scope and objectives under the direction of the Project Lead
- Identifies project and internal issues to senior colleagues and Project Lead
- Interacts professionally at all working levels within a client organization and within Parexel
- Identifies project and/or client needs to the Project Lead

Parexel-Related Responsibilities
- Meets established metrics as specified in scorecard on an annual basis
- Completes basic job-related responsibilities, including timesheets, expense reports,
- maintenance of CVs, project deliverable archiving, participation in internal
- initiatives/projects or as a mentor as requested by management
- Defines self-development activities with the support of management to keep current within the industry

Knowledge and Experience:
- Basic experience in an industry-related environment; CRO or Pharma experience with any regulatory agency (such as FDA, MHRA) exposure is a plus
- Previous CRO or Pharma experience acting in the capacity of a related Regulatory role or as a Junior Regulatory Affairs Associate would be desirable.
- Client-focused approach to work (Quality)

In return we will be able to offer you a structured career pathway and great development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!