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Regulatory Affairs Consultant - Core Team

Parexel -
Remote

Apply Now

Job Details

Qualifications

Education
Bachelor's degree
Communication skills

Full Job Description

Knowledge in Regulatory Affairs Activities, focusing on CTAs (Phase I-IV) for various Therapeutic Areas

Proficient in Regulations, ideally with some knowledge in New Zealand

Preferred experience: Phase I or Early Phase studies, Studies involving Medical Devices, GMOs, Radiopharmaceuticals, Biological Drugs, Labelling for Investigational Medicinal Products

Experience in Quality Documentation and CMC (Composition, Manufacturing and Control of Investigational Medicinal Products) could be a plus.

Key Accountabilities:

Project Execution

Typically works within a team environment but may work independently delivering services within their technical area of expertise
Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts
Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes
Capitalizes on opportunities to improve one’s own performance and may provide suggestions for improving project efficiencies and results to the project technical lead
Seeks out information from previous projects, other client work or from colleagues to complete assigned project activities
Produces quality work that meets the expectations of project Team Lead and the client
May serve as a Project Lead for small scale projects or a Work Stream
Lead on larger projects When serving as a Project Lead
Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)
Functions as the main client contact and ensures accurate project reporting is in place
Ensures that the project team delivers to meet the client expectations for quality and timeliness
Ensures that appropriate risk identification and issue-escalation procedures are in place
Ensures project specific training compliance of the project team
Ensures and/or manages project financials including provision of accurate revenue forecasts
Ensures that the project team understand and work to the scope of the contract
Identifies new opportunities through Change In Scope or add-on business from existing work
Ensures timely project close-out activities are completed

Consulting Activities and Relationship Management

Follows and implements the organization’s consulting models and methodologies
Provides technical and/or business consulting services within personal area of expertise
Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability
Collaborates with colleagues and client to identify and resolve technical and process issues
Leverages senior colleagues to discuss and propose resolutions to possible problems or conflicts. Seeks guidance periodically on appropriate methods of executing project activities
Interacts professionally at multiple levels within a client organization and within Parexel
Proactively assesses client needs and develops processes and solutions to address issues
Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided
Interactions result in clients expressing satisfaction with service provided
May prepare and/ or deliver presentation with the support of senior colleagues
May deliver training
Mentor of junior staff
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 engagements or through other industry experience
Communicates potential new business leads to PC management and account managers
May participate in project scoping calls and/or proposal preparation with the support of senior colleagues

Parexel-related Activities

Meets established metrics as specified in scorecard on an annual basis
Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management
Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)

Skills:

Project management knowledge
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Consulting skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:

Several years of experience in an industry-related environment

Education:

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

#LI-REMOTE

Apply Now

Refine Your Search

remote network jobs in remote

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