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Senior / Regulatory Affairs Associate - CTA

Employer
Parexel
Location
Ukraine
Salary
Competitive
Start date
1 Dec 2021
Closing date
31 Dec 2021

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

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 role can be office based in Kiev or you can be part home based (1-2 days per week) but you must be able to get into the Kiev office (at least 4 days per week in the first 6 months).The office is open planned, and you will be working in an innovative and collaborative environment working and connecting with colleagues from around the world.

As the Regulatory Affairs Associate(CTA) you will have an understanding of the organization's basic consulting models and methodologies, as well as basic knowledge of what services PC provides. You will be
technically competent and continually developing the skills as defined in the key accountabilities section . You will work under the general direction of a Project Lead and/or Technical SME,take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the group and the client.

This role will focus on the submission and management of the Regulatory Clinical Trial Applications to the MoH in the Ukraine.

Key Accountabilities:

Project Execution
- Works effectively within a team environment but may work independentlydelivering services within their area of competence
- Works within broad project guidelines as directed by the project lead and/ortechnical SMEs
- Takes initiative to prioritize work to achieve specified project outcomes whileconfirming alignment with project lead and line manager

Consulting Activities and Relationship Management
- Follows and implements the organization's consulting models andmethodologies under the guidance of the project lead and/or Technical SME
- Delivers consulting services within personal area of expertise under theguidance of the project lead and/or Technical SME
- Completes assigned activities within project scope and objectives with anunderstanding of issues which may impact project profitability under thedirection of the Project Lead and/or Technical SME

Business Development
- Continue to build a network of industry colleagues through relationshipsformed during project engagements or through other industry experience
- Communicates potential new business leads to PC management and accountmanagers
- May participate in project scoping calls and/or proposal preparation with thesupport of senior colleagues

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
Qualifications

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

Languages :
Must be Fluent in Ukrainian & English

Skills:
- Project management knowledge
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration 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:
- Some experience in an industry-related environment; experience with a regulatory agency is a plus but not essential
- Previous CRO / Pharma or Regulatory agency experience acting in the capacity of a Junior Regulatory Affairs Associate,Regulatory Affairs Associate or Senior Regulatory Affairs Associate is desirable.,
- Clinical Trial Application requirements knowledge is ideal
- Global (EU + ROW) CTA requirements knowledge is a bonus and if so we can consider at theRegulatory Affairs Consultant level.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus 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!Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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