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client advisor에 대한 최신 취업소식을 받고 싶습니다.

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Senior Regulatory Affairs Consultant - Project Management

Parexel -
서울

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채용공고 세부정보

상세 직무 내용

Required experience: Regulatory Compliance (GMP) and US NDA/EU MAA experience preferred.

Minimum 7 years of experience in Pharma, Biotech, or CRO required.

This role is responsible for Project Management of RA and Business Support.

Required language: ideally native Korean speaker and proficient in English to collaborate with the global team.

Flexible working arrangements are available, including hybrid work options that allow employees to work from home and in the office.

Key Accountabilities:

Project Execution

Works within a team environment or individually based on the project needs
Works within broad project guidelines and facilitates issue and conflict resolutions

As a Project Leader, provides overall project leadership:

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, and leads issue and conflict resolutions
Ensures project specific training compliance of the project team
Manages project financials including provision of accurate revenue forecasts
Ensures that the project team understands and works to the scope of the contract
Identifies new opportunities through Change in Scope (CIS) or add-on business from existing work
Ensures timely project close-out activities are completed
Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope
Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
Leverages information from previous projects or other client work to complete assigned project activities as well as facilitate business decisions
Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
Provides guidance to project team members, and acts as a mentor to junior staff

Consulting Activities and Relationship Management

Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
Facilitates client decision making by framing issues, presenting options and providing objective business advice
Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
Acts as a trusted advisor to clients and/or project team on technical and/or process issues
Supports development of business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
Interacts professionally at multiple levels including senior management within a client organization
Successfully penetrates executive management levels or other business units within a client organization
Facilitates clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management

Business Development

Maintain and continue to grow a network of industry colleagues through relationships formed during project engagements or through other industry experience
Actively participates in project scoping calls and proposal preparation
May deliver sales presentations and participate in bid defense meetings when needed
Contributes information to support the account planning process and integrated marketing programs
Contributes ideas for approaches to new clients or new service offerings

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 to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)
May participate in thought leadership activities (i.e. present speeches or seminars to industry groups and/or author articles.)

Skills:

High-level consulting skills
Critical thinking and problem-solving skills
Project leadership and management knowledge
Excellent interpersonal and intercultural communication skills, both written and verbal
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Proficiency in local language and extensive working knowledge of the English language
Networking
Business analysis
Self-confidence and control

Knowledge and Experience:

Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus

Education:

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

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client advisor에 대한 최신 취업소식을 받고 싶습니다.

Required experience: Regulatory Compliance (GMP) and US NDA/EU MAA experience preferred.

Minimum 7 years of experience in Pharma, Biotech, or CRO required.

This role is responsible for Project Management of RA and Business Support.

Required language: ideally native Korean speaker and proficient in English to collaborate with the global team.

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