Job Description
The Role
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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 Brisbane Australia Office, with a hybrid requirement to work in the office on average once per month. The ideal candidate will have established experience in working independently on a range of clinical development topics in compliance with current regulatory requirements. They will need to be competent in direct hands -on clinical writing and review of documents for regulatory submissions.
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n This is an excellent opportunity to progress
n your career at a rapidly growing product development, regulatory, and
n compliance consultant group. You will have the opportunity to play a key role
n in the development and mentoring of staff whilst providing high -quality
n regulatory technical advice and product development strategies for clients.
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Requirementsn
Role Requirements
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Provide
n strategic, technical and regulatory advice/services to clients with a
n special interest in Clinical development of human medicinal products.
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Establish
n and maintain a high level of technical knowledge in product development
n and international regulatory affairs.
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Provide
n innovative drug development plans, data gap analyses and international
n regulatory strategies from a Clinical perspective for complex products
n within the changing regulatory environment.
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Contribute
n to technical authorship and review of development regulatory documents
n including Regulatory Strategy Plans, Drug Development Plans, Clinical
n Trial Applications, Pre -INDs, INDs, Scientific Advice and Meeting Briefing
n Documents, Paediatric
plans/applications,
Investigator Brochures, IMPDs,
n Marketing Authorisation Applications, New Drug Applications, Biologic
n License Applications, DMFs according to area of expertise.
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Lead
n multi -jurisdiction programs of work and deliver consulting services within
n your respective area of expertise.
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Represent
n clients in regulatory agency interactions and provide regulatory solutions
n to agency objections.
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Ensure
n delivery of project goals within agreed timelines, maintaining oversight
n of project budgets.
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Lead
n meetings with internal and external stakeholders on matters related to any
n current and/or future projects, contracts, or new business opportunities.
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Support
n Scendea's Business Development in sales/marketing introductions and
n generate additional business from current clients.
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Line
n manage, train, and mentor members of the Scendea Operational team,
n including providing technical leadership.
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Skills and Experience
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n
A
n high scientific calibre with a relevant science focused BSc (or
n equivalent), and a higher degree in a biomedical field or equivalent
n (e.g., a life/physical science focused MSc or preferably a PhD).
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n
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n minimum of five years of drug development experience.
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n
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n minimum of five years of regulatory experience, working with either TGA, FDA,
n EMA, and/or MHRA submissions, including
meetings/negotiation.
Regulatory
n experience may include time within a National Competent Authority.
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Demonstrated
n clinical development experience across a range of therapeutic
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indications/disease
areas.
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Direct
n experience preferred in providing strategic regulatory planning from
n early -stage development up to marketing authorisation, and a proven
n ability to define and deliver creative scientifically driven solutions to
n technical development and regulatory issues.
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Proven
n ability and willingness to lead a team and deliver education and training
n in chosen field, both internally, and at scientific conference
n presentations.
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Exemplary
n organisational and time management skills with a high level of attention
n to detail, and the proven ability to work both proactively and
n autonomously.
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High
n level of verbal communication and presentation skills in English, computer
n literacy, and competency in MS Office programs.
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Willingness
n to work flexible hours and travel for short periods, sometimes at short
n notice, within the country of employment, or internationally.
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The Company
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Scendea is an international product development, regulatory,
n and compliance consulting group delivering market -leading scientific expertise
n & regulatory solutions, to advance healthcare innovation worldwide. We are
n passionate about delivering strategic and operational support to clients, with
n a strong commitment to problem -solving and redefining customer service. Our




n goal is to streamline the product development process, reduce time -to -market,
n and minimise overall development costs.
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With a current team of over 50 staff based in the US, UK,
n Netherlands, and Australia, Scendea is undergoing a period of significant
n growth, with the addition of new service lines to facilitate the delivery of
n expert and strategic global regulatory and compliance consulting services to
n our rapidly growing client base. We are equally committed to making a positive
n impact on society by managing our environmental impacts and contributing to a
n low -carbon economy. Our inclusive work culture values transparency, ethical
n collaboration with clients, and employee involvement in key decision -making
n processes, ensuring that our team is respected, supported, and engaged.
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Benefitsn

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Benefits Package
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A
n market-competitive salary.
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Generous
n bonus program, which rewards success.
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26
n days' annual leave entitlement plus public holidays and discretionary
n additional days leave for birthday and work anniversaries.
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Employer
n pension contribution/ compensation in line with country specific
n legislation.
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Provision
n of / compensation of Private Healthcare insurance.
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Access
n to Employee Assistance Programme.
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Employee
n Ownership Trust Scheme.
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n
A
n challenging and stimulating position for a dynamic and competent
n scientist, looking to contribute to a growing business and a rapidly
n expanding team.
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Coaching,
n mentoring and support of your continuous learning, and professional
n development within a highly recognised international team.
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n
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As a Scendea Employee
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Part of what makes Scendea successful is the highly
n motivated people who work for us and their enthusiasm for what we do and stand
n for. We recruit individuals whose passion, drive, integrity and
n customer orientation shines through. You are a motivated individual who
n can instil trust and confidence in our customer relationships whilst having a
n natural aptitude for getting the best out of people internally. You will
n inspire others through your commitment, motivation, expertise,
n professional manner and always placing the customer at the centre of everything
n you do.
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Eligibility & Conditions
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Applicants must
n reside and be eligible to work in Australia without the requirement for
n sponsorship now or in the future.
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📌 Senior Consultant, Clinical (Aus) (New South Wales)
🏢 Scendea
📍 New South Wales