Biotech Work, Jobs (with Salaries)

Country Approval Specialist - FSP
Thermo Fisher Scientific —Remote
- Full-time
- Remote
- English
- Bachelor's degree
- Organisational skills
Associate Technical Consultant (UK) - Entry-Level Consulting (Life Sciences)
Veeva Systems —London
- £40,000 a year
- Full-time
- Hybrid work
- Azure
- Computer Science
- Java
Associate Consultant (UK) - Entry-Level Technology Consulting (Life Sciences)
Veeva Systems —London
- £40,000 a year
- Full-time
- Hybrid work
- English
- Travel
- Communication skills
Research Associate
Abselion —Cambridge
- £35,000 - £39,000 a year
- Laboratory experience
- Microsoft Office
- Master's degree
Pharmaceutical Graphic Designer
Alvotech —Remote
- Full-time
- Remote
- English
- Bachelor's degree
- Organisational skills
Quality Assurance Associate
IXICO —London
- Full-time
- Hybrid work
- Computer literacy
- Microsoft Office
- Administrative experience
- Annual leave
- Employee assistance programme
Scientist - Cell Biology
Curve Therapeutics —Southampton
- £30,000 - £40,000 a year
- Full-time
- Doctoral degree
- Laboratory experience
- Master's degree
- Health & wellbeing programme
- Relocation assistance
Quick apply
Study Start-up Manager
Amgen —Aberdeen
- Remote
- Management
- Doctoral degree
- PMP
4d
Scientist
Veranova L P —Edinburgh
- Full-time
- Microsoft Office
- Master's degree
- Bachelor's degree
- Annual leave
- Life insurance
Quick apply
14d
Scientist Formulation Development
NextPharma GmbH —Livingston
- Full-time
- Doctoral degree
- English
- Microsoft Office
Scientist
Genomics —Oxford
- Full-time
- Hybrid work
- Machine learning
- Python
- Annual leave
Medical Information Specialist - US Hours
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- English
Quick apply
Business Analyst
AARK TECH SOLUTIONS GmbH —Remote
- Remote
- Azure
- Analysis skills
- APIs
Contract Specialist - FSP
Thermo Fisher Scientific —Remote
- 8 hour shift
- Remote
- English
- Organisational skills
- Contracts
Clinical Project Leader / Senior Project Leader - Biotech (Select EU countries)
Parexel —Remote
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
PRD Scientist
Veranova L P —Edinburgh
- Full-time
- APIs
- Annual leave
- Life insurance
Quick apply
Lab Automation Scientist
Lonza —Slough
- Full-time
- Doctoral degree
- Laboratory experience
- Java
Test Engineer
IXICO —London
- Full-time
- Hybrid work
- Java
- Master's degree
- Bachelor's degree
- Annual leave
- Employee assistance programme
Specialist Analytical Development
NextPharma GmbH —Livingston
- Full-time
- Microsoft Office
- Analysis skills
- Continuous improvement
- Life insurance
4d
Data Product Manager - OpenData Europe
Veeva Systems —Remote
- Full-time
- Remote
- Computer Science
- English
- SQL
- Work from home

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Country Approval Specialist - FSP

Thermo Fisher Scientific -
Remote

Apply Now

Job details

Full-time

Qualifications

Clinical research
English
Bachelor's degree
Organisational skills
Computer skills
Medical terminology
Communication skills
Negotiation
FDA regulations

Full job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What You’ll Do:

Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.

Work directly with assigned sites on all site related essential document collection and review.

Partner with internal Study Startup team, CROs, Clinical Operations teams, and partners to improve overall metrics and deliver processes.
Ensure standards are applied to the SSU processes across projects.
Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs and others.
Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
Review and provide feedback to management on site performance metrics.
Ensure accuracy and completeness of the eTMF for assigned sites during start up.

Education and Experience Requirements:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.)
Understanding of Clinical Trial Agreements, budgeting and fair market value principals.
Knowledge or FDA and ICH-GCP guidelines for conducting clinical research.

Knowledge, Skills and Abilities:

Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

Working Conditions and Environment:

Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves

Why Join Us:

We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

What we offer:

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD® clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Refine Your Search

Biotech jobs

Country Approval Specialist - FSP

Associate Technical Consultant (UK) - Entry-Level Consulting (Life Sciences)

Associate Consultant (UK) - Entry-Level Technology Consulting (Life Sciences)

Research Associate

Pharmaceutical Graphic Designer

Quality Assurance Associate

Scientist - Cell Biology

Study Start-up Manager

Scientist

Scientist Formulation Development

Scientist

Medical Information Specialist - US Hours

Business Analyst

Contract Specialist - FSP

Clinical Project Leader / Senior Project Leader - Biotech (Select EU countries)

PRD Scientist

Lab Automation Scientist

Test Engineer

Specialist Analytical Development

Data Product Manager - OpenData Europe

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