Scendea is seeking a highly motivated individual to join our global team as a full -time Senior Consultant (Clinical). This position is affiliated to our Bishop's Stortford, UK Office, with a hybrid requirement to work in the office 1 day per month. The ideal candidate will have established experience in working independently on a range of clinical development topics in compliance with current requirements. They will need to be competent in direct hands -on clinical writing and review of documents for regulatory submissions.<\/span>
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This is an excellent opportunity to progress your career at a rapidly growing product development, regulatory, and compliance consultant group. You will have the opportunity to play a key role in the development and mentoring of staff whilst providing high -quality regulatory technical advice and product development strategies for clients.<\/span>
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Requirements<\/h3><\/span><\/span><\/div>Provide strategic, technical and regulatory advice/services to clients with a special interest in Clinical development of human medicinal products.<\/span><\/span><\/span><\/li>Establish and maintain a high level of technical knowledge in product development and international regulatory affairs.<\/span><\/span><\/span><\/li>Provide innovative drug development plans, data gap analyses and international regulatory strategies from a Clinical perspective for complex products within the changing regulatory environment.<\/span><\/span><\/span><\/li>Contribute to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, Pre -INDs, INDs, Scientific Advice and Meeting Briefing Documents, Paediatric plans/applications, Investigator Brochures, IMPDs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, DMFs according to area of expertise.<\/span><\/span><\/span><\/li>Lead multi -jurisdiction programs of work and deliver consulting services within your respective area of expertise.<\/span><\/span><\/span><\/li>Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.<\/span><\/span><\/span><\/li>Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets.<\/span><\/span><\/span><\/li>Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.<\/span><\/span><\/span><\/li>Support Scendea's Business Development in sales/marketing introductions and generate additional business from current clients.<\/span><\/span><\/span><\/li>Line manage, train, and mentor members of the Scendea Operational team, including providing technical leadership.<\/span><\/span><\/span><\/li><\/ul>Skills and Experience<\/span><\/span><\/b><\/span><\/span><\/p><\/span><\/span><\/ul>A high scientific calibre with a relevant science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life/physical science focused MSc or preferably a PhD).<\/span><\/span><\/span><\/li>A minimum of five years of drug development experience.<\/span><\/span><\/span><\/li>A minimum of five years of regulatory experience, working with either TGA, FDA, EMA, and/or MHRA submissions, including meetings/negotiation. Regulatory experience may include time within a National Competent Authority.<\/span><\/span><\/span><\/li>Demonstrated clinical development experience across a range of therapeutic indications/disease areas.<\/span><\/span><\/span><\/li>Direct experience preferred in providing strategic regulatory planning from early -stage development up to marketing authorisation, and a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues.<\/span><\/span><\/span><\/li>Proven ability and willingness to lead a team and deliver education and training in chosen field, both internally, and at scientific conference presentations.<\/span><\/span><\/span><\/li>Exemplary organisational and time management skills with a high level of attention to detail, and the proven ability to work both proactively and autonomously.<\/span><\/span><\/span><\/li>High level of verbal communication and presentation skills in English, computer literacy, and competency in MS Office programs.<\/span><\/span><\/span><\/li>Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.<\/span><\/span><\/span><\/li><\/ul><\/div><\/span>Benefits<\/h3>A competitive salary.<\/span><\/span><\/span><\/li>Generous bonus program, which rewards success.<\/span><\/span><\/span><\/li>26 days’ annual leave entitlement plus public holidays and discretionary additional days leave for birthday and work anniversaries.<\/span><\/span><\/span><\/li>Employer pension contribution/ compensation in line with country specific legislation.<\/span><\/span><\/span><\/li>Provision of / compensation of Private Healthcare insurance.<\/span><\/span><\/span><\/li>Access to Employee Assistance Programme.<\/span><\/span><\/span><\/li>Employee Ownership Trust Scheme.<\/span><\/span><\/span><\/li>A challenging and stimulating position for a dynamic and competent scientist, looking to contribute to a growing business and a rapidly expanding team.<\/span><\/span><\/li>Coaching, mentoring and support of your continuous learning, and professional development within a highly recognised international team.<\/span><\/span><\/span><\/span><\/li><\/ul>As a Scendea Employee <\/span><\/span><\/b>Part of what makes Scendea successful is the highly motivated people who work for us and their enthusiasm for what we do and stand for. We recruit individuals whose passion, drive, integrity and customer orientation shines through. You are a motivated individual who can instil trust and confidence in our customer relationships whilst having a natural aptitude for getting the best out of people internally. You will inspire others through your commitment, motivation, expertise, professional manner and always placing the customer at the centre of everything you do.<\/span><\/span><\/p>Eligibility & Conditions<\/span><\/span><\/b><\/span><\/span><\/p>Applicants must reside and be eligible to work in the UK without the requirement for sponsorship now or in the future.<\/span><\/span><\/span><\/p><\/div><\/span>
Senior Consultant (Clinical) employer: Scendea
Scendea is an exceptional employer that fosters a collaborative and innovative work culture, providing employees with the opportunity to grow their careers in the dynamic field of regulatory consulting. Located in Bishop's Stortford, UK, our team enjoys a blend of in-office collaboration and remote flexibility, along with comprehensive training and mentorship programs that empower staff to excel in their roles. Join us to make a meaningful impact in clinical development while benefiting from a supportive environment that values professional growth and high-quality client service.
