Associate Consultant - UK Internship (US applicants only)

The Role

Scendea is seeking a highly motivated individual to join our global team as an Associate Consultant in a paid internship placement within our Product Development and Regulatory Consulting team. This 6month internship starting in July 2025 will be based at our UK Head Office and offers the opportunity to gain valuable handson experience. Upon successful completion of the internship you will be eligible to transition into a permanent position at our Washington D.C. office which is set to open in January 2026.

To be considered for this internship you must be eligible to work in the US and willing to relocate to Washington D.C. for the permanent role after the internship concludes. This exciting opportunity is ideal for someone wanting to start or develop a career in regulatory project management regulatory affairs and medical/scientific writing. The successful candidate will have a strong interest in facilitating the entry of Client s compounds into clinical trials and assisting in the activities required for successful international marketing approvals.

Eligibility & Conditions

Applicants must be eligible to obtain a Temporary Worker: Government Authorised Exchange Visa to work in the UK and be able to fund their residence for the duration of the placement. Applicants must be willing to reside and work in Washington D.C. in the future without the need for sponsorship. Further information regarding UK Internships will provided in interview or visit our LinkedIn page for more date for applications is 9th June 2025 and candidates will be notified of the outcome of their application no later than 13th June 2025.

Requirements

• Project management to ensure delivery of contracted activities which could include direct contact with multiple clients and stakeholders.
  
• Complete relevant tasks within scope or under supervision to ensure successful project delivery with adherence to timelines and budgets.
  
• Support in the creation and delivery of highquality billable related product development and regulatoryrelated documentation for clients.
  
• Develop and maintain technical knowledge in the area of product development and international regulatory affairs.
  
• Perform literature and data searches collating and summarising data in an appropriate manner for stakeholders.
  
• Manage project documentation within company systems.
  
• Support and develop strategic drug development strategies in the area of regulatory affairs NonClinical Clinical and CMC development.
  
• Assess and analyse scientific data.
  
• Assist in the development and maintenance of Standard Operating Procedures (SOP) and other relevant training materials.
  
• Support the preparation of written estimates quotations and contracts for clients.
  
• Be an active participant of the global team to support colleagues and the company in achieving the company goals.A high scientific calibre with a life science focused BSc (or equivalent) and a higher degree (e.g. a life science focused MSc or PhD).
  

Skills and Experience

• A general awareness of drug development and medical/regulatory affairs is required and prior industry experience would be advantageous.
  
• Any experience with regards to medical/scientific writing would be a strong asset for this position.
  
• Excellent writing skills in English able to summarise complex scientific data thus facilitating the review of such data by external parties.
  
• High level of verbal communication and presentation skills in English computer literacy and competency in MS Office programs.
  
• Exemplary organisational and time management skills with a high level of attention to detail ability to balance competing priorities and to complete work within a set timeframe.
  
• Proven ability to work proactively autonomously and as part of a team.
  
• Some experience in project management would be a significant advantage for this role. Such as managing a research project (e.g. during a PhD).
  
• Willingness to work flexible hours and travel for short periods sometimes at short notice within the UK and or internationally.
  
• A clear ambition to progress your career in medical/scientific writing and regulatory consulting.
  
• Commercial experience is not a prerequisite for this position.
  

Benefits

• A competitive salary.
  
• 26 days holiday( prorate d) plus public holidays and discretionary additional day for birthday.
  
• Access to Employee Assistance Programme.
  
• Employee Ownership Trust Scheme.
  
• Coaching mentoring and support of your continuous learning and professional development within a highly recognised international team.
  

Key Objectives Provide strategic, technical, and regulatory advice/services to clients in the area of clinical development of human medicinal products, across a wide range of therapeutic indications Offer support and advice across a broad range of regulatory activities Provide innovative drug development plans, data gap analyses and international regulatory strategies from a Clinical perspective for complex products within the changing regulatory environment Support Scendea's Business Development in sales/marketing introductions, preparation of project proposals & educational materials, review written estimates, quotations and contracts for Clients as required Contribute to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, IMPDs, CSRs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, according to area of expertise Provide technical leadership to other members of the Scendea consultancy team, including other Principal and Senior Consultants Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise Represent Scendea clients in regulatory agency interactions and provide regulatory solutions to agency objections Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets Generate additional business from current Clients through exceeding expectations relating to the quality, delivery time and cost of services, and empower others to do the same Educate clients on current regulatory trends and expectations. Where relevant champion the client's view for development of products with other contractors such as CROs Establish and maintain a high level of technical knowledge in the area of product development and international regulatory affairs Support the development and operation of the alliance network and new partnership opportunities Challenge the regulatory status quo from a technical and scientific standpoint Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities Provide strategic input/support to Scendea Directors and the company's growth plan Line manage individual contributors, and in doing so, provide ongoing coaching and mentoring Mentoring and training junior members of the Scendea consultancy team (including Senior Consultant, Consultant and Associate levels) Represent Scendea at seminars, conferences, and events Location & Reporting Structure The role will be affiliated to our UK office in Bishop s Stortford The role will be flexible, working from home with a minimum of one office-based day per month The selected candidate will report directly to Head of Clinical The role includes Line Management responsibility Skills and Experience A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science focused MSc or preferably a PhD) At least fifteen years of drug development experience, with at least five years in the area of biotechnology and regulatory affairs Clinical development experience across a range of therapeutic indications/disease areas Preference for candidates with significant experience in drug development covering Europe, UK, and the United States Proven ability in defining and delivering creative scientifically driven solutions to technical development and regulatory issues Preference for candidates who have direct experience in providing strategic regulatory planning for the delivery of industry development goals, up to marketing authorisation Experience in negotiation with multinational regulatory authorities including, as a minimum, European, UK and US authorities. Proven ability to deliver education via scientific conference presentations in chosen field and training of subordinates A professional manner and presentable appearance for meeting customers/clients Ability to work in a proactive and autonomous manner as well as leading a global team, to ensure high-quality of deliverables Ability to balance competing priorities and complete work within a set timeframe Exemplary organisational skills with a high level of attention to detail Exemplary verbal communication and presentation skills in English High level of computer literacy and competency in MS Office programs Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the Netherlands, Europe, UK or internationally, with travel to the UK office, Bishop s Stortford on at least a quarterly basis Terms and Conditions Applicants must be eligible to work in the UK, Netherlands or Australia.