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Health Vacancy N.N. 10721557
Therapeutic Goods Administration Closing date: Friday, 30 March 2018
Job Title: Director, Pharmaceutical Chemistry Section (PCS)
Division: Medicines Regulation
Branch: Scientific Evaluation
Section: Pharmaceutical Chemistry
Job Type: Ongoing, Full-time, Part-time
Salary: $119,908 - $141,965
Location: Symonston - ACT
Classification: Executive Level 2
Agency Employment Act: PS Act 1999
Position No: 18-MR-0273

Job Description

Duties


The Scientific Evaluation Branch (SEB) is seeking a qualified and experienced Director for its Pharmaceutical Chemistry Section (PCS). SEB sits within the Medicines Regulation Division and is responsible for approving applications to market biologicals and generic medicines in Australia. The Branch also provides scientific advice to support the decisions made elsewhere within the Division, in particular evaluating the toxicological and pharmaceutical chemistry aspects of therapeutic products and providing expertise in the biological sciences.

The Pharmaceutical Chemistry Section (PCS) is responsible for the evaluation of chemistry, manufacturing, quality control and bioavailability data submitted by pharmaceutical companies in support of applications for the registration of new medicines and variations to existing medicines. The section is also responsible for the approval of generic medicines.

Key Responsibilities
• Leading and managing the day-to-day work and long-term planning of the Pharmaceutical Chemistry Section of up to 30 staff during a period of change;
• Contributing to the regulation of medicines through overseeing the evaluation of the pharmaceutical chemistry (in particular quality and bioequivalence) of new medicines submitted for market authorisation, and applications to vary approved medicines;
• Managing regulatory and operational issues within relevant legislative and regulatory frameworks, and providing advice to inform policy and regulation;
• Building team capability, coaching and mentoring staff, implementing change through collaboration, and fostering a culture that accords with the Department’s Behaviours in Action;
• Leading continuous business improvement and supporting implementation of reform projects including those relating to the Expert Panel Review of Medicines and Medical Devices;
• Maintaining and applying awareness of, contributing to, and promoting relevant best practice within Australia and internationally, including pharmacopoeia, regulatory requirements, standards, guidelines and policy;
• Working closely with colleagues and contributing as a member of the Scientific Evaluation Branch leadership team to deliver a cohesive program of work that delivers on strategic and tactical imperatives;
• Collaborating with other branches and divisions, particularly with respect to clinical evaluation of prescription medicines and pharmacovigilance;
• Representing the branch in internal and external fora and providing quality, timely, influential advice to relevant internal and external stakeholders including advisory committees, industry, colleagues within government and comparable overseas regulators;
• Making balanced decisions using professional judgement, factoring in risks and being sensitive to context; and
• Working flexibly in a high pressure environment to achieve team goals and broader organisational objectives by providing leadership and management support, undertaking other tasks and managing projects as required and directed.

We are seeking candidates who have:
• The ability to lead and manage a large team of scientists;
• An excellent understanding of the regulatory framework for therapeutic goods in Australia, including applicable standards and guidelines, or demonstrated ability to rapidly learn and apply this knowledge;
• Demonstrated high level strategic and scientific analytical ability;
• The ability to lead, promote and make balanced decisions that may impact directly on the agency/externally using professional judgement, factoring in risks and being sensitive to context;
• High level interpersonal, liaison and stakeholder management skills, including the ability to develop productive working relationships to identify opportunities, facilitate cooperation, achieve outcomes and communicate the strategic direction and vision of the agency;
• The ability to work flexibly in a high pressure environment while responding positively and flexibly to change.
• The ability to find innovative strategies to overcome roadblocks to deliver and drive projects; and
• High level written and verbal communication skills.
 

Eligibility


Mandatory Qualification:
A degree or equivalent in a relevant scientific discipline and/or management from an Australian tertiary institution, or comparable overseas qualifications.

To be eligible for employment with the Department of Health applicants must be an Australian citizen at the time an offer of employment is made.

An applicant’s suitability for employment with Health will also be assessed through a variety of pre-employment check processes, such as:
• Satisfactory completion of an Australian Federal Police criminal history check, and where relevant a Working with Children and Vulnerable People Check.
• Completion of a medical declaration and pre-employment medical (where required).
• Providing evidence of qualifications (where required).
• Obtaining and maintaining a security clearance at the required level (where required).
 

Notes


Applications close 11:30PM AEDT.

Applicants should quote reference number 18-MR-0273 to assist when making an enquiry.

RecruitAbility applies to this vacancy. Under the RecruitAbility scheme you will be invited to participate in further assessment activity for the vacancy if you choose to apply under the scheme; declare you have a disability; and meet the minimum requirements for the job. For more information see: http://www.apsc.gov.au/priorities/disability/recruitability.

About Therapeutic Goods Administration 

About the TGA
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including, vaccines, medicines and medical devices.

The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
We evaluate therapeutic goods before they are marketed and monitor them once they are on the market and assess the suitability of medicines and medical devices for export from Australia.
We also regulate manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality.

Visit our website at www.tga.gov.au for further information regarding this role and TGA. Your interest in the TGA as a potential employer is appreciated.

To Apply

Position Contact: Lindsey Carroll, 02 6221 6878
Agency Recruitment Site: http://www.tga.gov.au/
AGENCY INFORMATION
 
Applicants to vacancies notified in all formats of the electronic Public Service Gazette should be aware that;
.  the names of successful applicants may also be notified in all formats of the electronic Public Service Gazette
.  applicants found suitable may be offered similar employment opportunities by other Australian Public Service agencies
 
This notice is part of the electronic Public Service Gazette PS11-Fri - 09 Mar 2018 Published by Australian Public Service Commission.
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