Associate Director, Start Up and Regulatory Affairs - London, United Kingdom - Ergomed

Ergomed

Verified Company

London, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient's lives.

LI - #remote

Job Description:

Main responsibilities for the role are:

Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready ensuring all activities are performed within agreed timelines and budgets
Develops and maintains strategic relationships with customers in alignment with their assigned projects.
Provide senior level input to client and project specific SSU and regulatory strategy, keeping in mind the overall start up objectives, risk assessment and mitigation plans
Collaborates with business leads for business development, contracts, proposals development and project budgets and represent SSU in BD meetings
Provide line management, training and coaching to members of staff
Contributes to and may lead process improvement initiatives across the SSU and Regulatory department.
Establishes and maintains training materials for assigned areas.
Provide strategic SSU and regulatory guidance, training, coaching and mentoring to junior members
Deputise for the Director of Study Start Up and Regulatory Affairs

Qualifications:

Bachelor's Degree in Chemistry, Life Sciences or Medicine
Minimum 10 years CRO industry experience and/or a minimum 8 years' experience working in a SSU/Regulatory Affairs, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job (master degree +5 years, experience in SSU/RA)

Other skills and abilities:

Strong organizational skills with proven ability to handle multiple projects in a fastpaced environment
Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
Excellent understanding of clinical trial startup and regulatory processes.
Very good written and verbal communication skills to clearly and concisely present information

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach.

Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language

Our Offer:

Competitive salary
Dynamic team of colleagues in a fastgrowing company possibility for your quick career growth
Multicultural environment, English as a company language
Strong emphasis on personal and professional growth

**#LI-remote