20 Aug
|
Important Group
|
Milton
20 Aug
Important Group
Milton
The Role
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.
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.
Requirements
Role Requirements
- Provide
strategic, technical and regulatory advice/services to clients with a
special interest in Clinical development of human medicinal products.
- Establish
and maintain a high level of technical knowledge in product development
and international regulatory affairs.
- Provide
innovative drug development plans, data gap analyses and international
regulatory strategies from a Clinical perspective for complex products
within the changing regulatory environment.
- 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.
- Lead
multi -jurisdiction programs of work and deliver consulting services within
your respective area of expertise.
- Represent
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.
- Lead
meetings with internal and external stakeholders on matters related to any
current and/or future projects, contracts, or new business opportunities.
- Support
Scendea's Business Development in sales/marketing introductions and
generate additional business from current clients.
- Line
manage, train, and mentor members of the Scendea Operational team,
including providing technical leadership.
Skills and Experience
- 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).
- A
minimum of five years of drug development experience.
- 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.
- Demonstrated
clinical development experience across a range of therapeutic
indications/disease areas.
- 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.
- Proven
ability and willingness to lead a team and deliver education and training
in chosen field, both internally, and at scientific conference
presentations.
- Exemplary
organisational and time management skills with a high level of attention
to detail, and the proven ability to work both proactively and
autonomously.
- High
level of verbal communication and presentation skills in English, computer
literacy, and competency in MS Office programs.
- Willingness
to work flexible hours and travel for short periods, sometimes at short
notice, within the country of employment, or internationally.
The Company
Scendea is an international product development, regulatory,
and compliance consulting group delivering market -leading scientific expertise
& regulatory solutions, to advance healthcare innovation worldwide. We are
passionate about delivering strategic and operational support to clients, with
a robust commitment to problem -solving and redefining customer service. Our
goal is to streamline the product development process,
reduce time -to -market,
and minimise overall development costs.
With a current team of over 50 staff based in the US, UK,
Netherlands, and Australia, Scendea is undergoing a period of significant
growth, with the addition of new service lines to facilitate the delivery of
expert and strategic global regulatory and compliance consulting services to
our rapidly growing client base. We are equally committed to making a positive
impact on society by managing our environmental impacts and contributing to a
low -carbon economy. Our inclusive work culture values transparency, ethical
collaboration with clients, and employee involvement in key decision -making
processes, ensuring that our team is respected, supported, and engaged.
competitive salary.
bonus program, which rewards success.
additional days leave for birthday and work anniversaries.
legislation.
of / compensation of Private Healthcare insurance.
to Employee Assistance Programme.
Ownership Trust Scheme.
expanding team.
development within a highly recognised international team.
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
natural aptitude for getting the best out of people internally. You will
professional manner and always placing the customer at the centre of everything
you do.
sponsorship now or in the future.