Regulatory specialist Work, Jobs in Cambridge, Eng (with Salaries)

Clinical Science Specialist
MoonLake Immunotherapeutics —Cambridge
- Hybrid work
- Doctoral degree
- Master's degree
Quick apply
12d
Specialist - HSE
Marshall Land Systems Ltd —Cambridge
- £45,000 - £50,000 a year
- Full-time
- Continuous improvement
- In-person
- Communication skills
Quick apply
6d
Senior Specialist, Data Science
AstraZeneca —Cambridge
- Computer Science
- English
- Master's degree
2d
Quality Assurance Administrator
Hologic —Cambridge
- £32,000 - £40,000 a year
- Microsoft Powerpoint
- Microsoft Word
- Engineering
Medical Information Specialist with Norwegian
Thermo Fisher Scientific —Cambridge
- Full-time
- English
- Organisational skills
- Computer skills
Biomedical Engineering Specialist
NeoGenomics Laboratories —Babraham
- Monday to Friday
- Engineering
- Maintenance
- Organisational skills
Quick apply
Senior AI Data Readiness Specialist
Arm —Cambridge
- £66,600 - £90,000 a year
- Hybrid work
- AI
Quality Compliance Manager
Marshall of Cambridge (Holdings) Limited —Cambridge
- Full-time
- Management
- Team management
- Travel
Medical Information Specialist with Danish
Thermo Fisher Scientific —Cambridge
- Full-time
- English
- Organisational skills
- Computer skills
Principal Hardware Performance Specialist
Arm —Cambridge
- £126,200 - £170,800 a year
- Hybrid work
- Windows
- Linux
2d
Principal Asset Management Advisor - Regulatory
Mott MacDonald —Cambridge
- Full-time
- Hybrid work
- Analysis skills
- Mentoring
- Agile
- Employee discount
Senior Offset/Industrial Cooperation Manager
Marshall of Cambridge (Holdings) Limited —Cambridge
- Full-time
- Hybrid work
Risk & Compliance Manager
Jensten Group —Huntingdon
- Remote
- Annual leave
- Employee discount
Quick apply
Therapy Development Specialist
Medtronic —Cambridge
- £55,040 - £82,560 a year
- Full-time
- Sales
- Laboratory experience
- Negotiation
Medical Facility Data Specialist-Level 1
French Consulting —Lakenheath
- Full-time
- Military
- English
- Microsoft Office
Quick apply
SRA, Histology
Flagship Pioneering, Inc. —Cambridge
- Laboratory experience
- Master's degree
- Bachelor's degree
13d
Security Business Analyst
Arm —Cambridge
- £79,600 - £107,600 a year
- Hybrid work
- Analysis skills
- Agile
- Communication skills
Project Manager
Graphcore —Cambridge
- Project management
- Organisational skills
- AI
13d
Principal AI & Compute Engineer, Workforce Development
Arm —Cambridge
- £126,200 - £170,800 a year
- Hybrid work
- Travel
- AI
- Communication skills
Legionella Risk Assessor
SOCOTEC UK & Ireland —Cambridge
- Full-time
- Hybrid work
- Bachelor's degree
- IT
- Employee assistance programme
- Employee discount
Quick apply
12d

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regulatory specialist jobs near cambridge, eng

Clinical Science Specialist

MoonLake Immunotherapeutics
Cambridge

Quick apply

Job details

12 days ago

Qualifications

Doctoral degree
Master's degree

Full job description

Job Purpose

The Clinical Scientist Specialist contributes to the clinical development strategy and supports the execution of the plan for the assigned molecule(s)/indication(s).

Key responsibilities:

Clinical Science Support, Data Review & Cross functional Collaboration
Collaborates with clinical operations, Medical Directors, and other groups etc. in the development of clinical study documents, including protocol, Informed Consent Form (ICF), Case Report Forms (CRFs), Clinical Study Reports, etc.
Leads and/or contributes to the development of clinical presentations and other documents for internal governance/team meetings or external communications (e.g., Investigator and Steering Committee meetings, study coordinator or clinical research administrator training, study newsletters, communications to study sites, Key Opinion Leader (KOL) interactions, and other events, publications).
Maintains and provides Scientific and process Expertise for Process Improvement & Compliance projects (enhancements/development of core and sub team processes, structures, systems, tools and other resources)

Your profile

Education: Postgraduate degree (MSc or PhD) in a science discipline.

Experience:

3 to 5 years experience in the pharmaceutical and/or Biotech industry, preferably in the relevant disease areas (dermatology/rheumatology).
Exposure to medical monitoring of Phase II or Phase III clinical trials.

Skills/knowledge/behavioural competencies:

Robust working knowledge of GxP and related regulatory standards relating to drug development and promotional activities.
Excellent oral and written skills.
Ability to interpret, process and present information/data in innovative ways to meet the needs of multiple stakeholders.
Highly organized, able to prioritize work, works well under pressure and meets deadlines.
Independent, self-starter with a proactive, problem-solving approach.
Ability to work with and influence others in a flexible, collaborative style with internal and external teams (including CROs and Consultants).
Ability to see complex projects to completion, and to work on a broad range of tasks within a project.

Work Location:

2 days a week in our brand new Cambridge or Porto Office(s)

Why us?

An exciting job opportunity awaits!

MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

What we offer:

Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.

Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.

Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.

Our Core Values

We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:

We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.

We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.

We unlock value: We aspire to create long-term value for investors and communities.

About us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.

We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.

Further information is available at www.moonlaketx.com

Quick apply

Refine Your Search

regulatory specialist jobs in cambridge, eng

Clinical Science Specialist

Specialist - HSE

Senior Specialist, Data Science

Quality Assurance Administrator

Medical Information Specialist with Norwegian

Biomedical Engineering Specialist

Senior AI Data Readiness Specialist

Quality Compliance Manager

Medical Information Specialist with Danish

Principal Hardware Performance Specialist

Principal Asset Management Advisor - Regulatory

Senior Offset/Industrial Cooperation Manager

Risk & Compliance Manager

Therapy Development Specialist

Medical Facility Data Specialist-Level 1

SRA, Histology

Security Business Analyst

Project Manager

Principal AI & Compute Engineer, Workforce Development

Legionella Risk Assessor

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