Senior Associate, Regulatory Intelligence and Analytics

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.  

Job Description

The Associate Director Start Up and Regulatory Affairs oversees and contributes to the day-to-day start-up and regulatory operations, provides input on new business development opportunities, develop and maintain relationships with clients, and provide guidance and support in regards to study start-up and regulatory. Associate Director Start Up and Regulatory Affairs represents a management position in first line of management under direction of Head of Study Start Up and Regulatory Affairs.

Project Related

• 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.
• Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. 
• 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
• Supports reporting of department and team metrics/cycle times and strategies to improve metrics/cycle times.
• Establishes and maintains training materials for assigned areas.  

Business Development/Proposals

• Collaborates with business leads for business development, contracts, proposals development and project budgets and represent SSU in BD meetings

Line Management

• Provide line management, training and coaching to members of staff
• Manage assignment of workload and monitor performance/utilization
• Review and communicate the need for further recruitment into the department and participate in the selection process as required
• Communicate role, responsibilities, and performance expectations to all members of the team
• Participate in performance review process and provide salary increases promotions or adjustment recommendations for all direct and indirect reports
• Interact with direct supervisors for all indirect reporting personnel to resolve any noted skill deficiencies and arrange for appropriate action to be taken to address problems.
• Deputise for the Director of Study Start Up and Regulatory Affairs

Intelligence

• Develop and ensure appropriate management and maintenance of Regulatory Intelligence.
• Prepare and/or contribute to the Regulatory Newsletter, monthly reports and update regulatory database, slides and trackers as applicable

Audits

• Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.

Vendor Qualification

• Contribute to the assessment and qualification of new vendors and ensure appropriate training and compliance with company standards. Support ongoing evaluation of existing vendors.

SOPs and company initiatives

• Contributes to and may lead process improvement initiatives across the SSU and Regulatory department.
• Design, implement and ensure compliance of procedures to ensure the smooth running of the division

Qualifications

Min Bachelor’s Degree (preferably Bachelor of Life Science)

• 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)

Experience with leading at least 7 studies from award and into maintenance.

• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Excellent understanding of clinical trial start-up and regulatory processes.
• Strong organizational skills with proven ability to handle multiple projects in a fast-paced environment..
• Excellent communication, presentation and interpersonal skills.
• Quality-driven in all managed activities.
• Strong negotiating skills.
• Strong problem-solving skills.
• Strong ability to analyze data and make appropriate decisions.
• Ability to mentor and coach lesser experienced staff

Remarkable attention to detail

Proficiency in English, both written and verbal

Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), outlook and Internet.

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 fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth

#Li-Remote