Our client is an industry leader in life saving specialty pharmaceuticals with an enviable product portfolio and exciting pipeline of late stage developments. Due to continued success and sustained growth Adroit People have been retained to secure a Quality Assurance Manager for our client’s Sydney operations.

This is a pivotal leadership role responsible for developing and managing Quality Systems to ensure compliance to corporate, regulatory and marketing requirements.

Responsibilities

• Develop and implement strategies for the continual development of the quality system based on industry best practice and individual analysis of specific needs.
• Develop and maintain systems to measure performance against established standards, ensuring that the legal requirements regarding imported products are fully met.
• Plan, implement and manage the training and education of internal stakeholders.
• Enhance external audit programmes and develop creative approaches to evaluating vendor and 3PL performance.
• Co-ordinate product inventory and orders handling for non-contractor based activities.
• Participate in product incident reviews
• Liaison with local Regulatory Authority
• Work with supply partners to improve robustness of overall product supply quality systems and compliance to regulatory standards.
• Build positive working relationships with internal and external customers to ensure QA is recognized as integral to business success and growth.
• Foster and promote a quality culture through ongoing education, consultation, leadership, and management review.

Requirements:

• B.Sc. in relevant discipline coupled with proven experience (3+ yrs) in Quality Management positions within the Australian pharmaceutical industry.
• Strong knowledge of GMPs, GDPs, Good Wholesaling Practice, importation and controlled drugs and familiar with other International GMP/ GDP standards
• Strong knowledge of certified quality driven industry or equivalent experience is highly advantageous.
• Demonstrated experience in successful management of internal and external stakeholder interests.
• Excellent problem solving and analytical skills, along with highly developed stakeholder management expertise.
• Proven ability to lead and manage project teams.

Remuneration:

Salary: $ Six Figure Package

For more information, or to apply, contact Diarmuid on 02-80960060 / email: dsexton@adroitpeople.com.au

Confidentiality Assured.

Our client is committed to delivering revolutionary Medical Device technologies and are the market leaders in latest technological advancements. Due to increased growth in the Chinese market they have exclusively retained Adroit People to source an accomplished Regulatory Affairs Specialist to assist in developing regulatory strategy for their China affiliate operations .

Reporting to the Regional Regulatory & Reimbursement Director the successful candidate will be responsible for the development and implementation of regulatory, quality and reimbursement strategies for the Chinese market.

Responsibilities:

• Deliver product registrations on time and within budget, and ensure compliance of existing products with regulatory requirements.
• Develop and maintain relationships with the key regulatory stakeholders including; SFDA, CMDE and other industry groups.
• Contribute to the development and delivery of the regional strategy and business plans to deliver on company strategic agenda
• Review promotional material and plans and provide feedback to ensure alignment with relevant advertising codes and legislation
• Work with global colleagues to ensure quality and regulatory issues meet the required standards for the Asia-Pacific markets.
• Review artwork, labelling and packaging for new and existing products in to ensure compliance with regulatory standards.
• Maintain compliance for the Asia Pacific local and regional offices to the markets relevant quality standards.
• Maintain the adverse event database and report incidents as required.
• Develop country-specific strategy and commercialisation objectives.
• Drive the closure of corrective/preventative actions assigned to the Asia-Pacific region.
• Support and promote Regulatory Affairs and ensure regulatory compliance in Greater China
• Keep up to date with changes to regulation and industry codes through attendance at conferences and workshops.

Requirements:

• Approximately 5-10 years experience in medical device regulatory affairs in China
• Expert knowledge of the Medical Device regulations (relevant statutes and practices)
• People management experience
• Excellent project management skills
• Excellent verbal and written communication in Mandarin and English languages
• An open communication style.
• Demonstrate strong commercial acumen
• Have proven ability to manage projects across a complex environment.
• Possess superior problem resolution and negotiation skills and be open to continuous development.

Remuneration:
$ Salary – Excellent depending on experience, plus benefits

For more information, or to apply contact Diarmuid on +612 80960060 /email: dsexton@adroitpeople.com.au

Confidentiality Assured.

Our client is a leading medical technologies multinational with operations on a truly global scale. With a firm commitment to innovation and integrity of their products our client is the stand-out leader of the industry. Due to continued growth and increased market share we have been retained to source and select an accomplished Sales Executive within the Tokyo region to implement business and account management plants and achieve future sales growth for the business.

This is an excellent opportunity for career-minded professionals to progress their career in a dynamic and rewarding work environment.

Accountabilities:

• Focus on achieving sales growth in allocated territory and meet sales targets on a quarterly basis;
• Prepare and execute sales and account management plans for key accounts to meet sales targets in collaboration with clinical account management partner and account management team members;
• Identify and evaluate new opportunities for growth;
• Support channel development and alliance partners to generate potential client/patient markets
• Raise awareness of products and the referral pathway amongst affiliated healthcare professionals (e.g. GP’s and Ear, Nose & Throat Specialists [ENT], etc), and potential candidates through platforms such as sales calls and information seminars/meetings.
• Build strong relationships with ENT clinics and influencers in assigned territory
• Work with Clinical, marketing and Customer Service team to manage/handle various requirements from customers, implement marketing plans and co-ordinate events
• Proactively seek competitive market intelligence and utilize this to strategically manage accounts.

Requirements:

• Degree Qualification with minimum 5 years’ sales experience within medical technologies industry;
• Proven track record of sales accomplishment, ideally within ENT health pathways.
• Flexibility to travel extensively;
• Native fluency in Japanese, plus competent spoken English skill and basic written language skills for better understanding of product and evidence based messaging.
• Preference for superior English language skills to capitalise on opportunities for international conferences and seminars within the industry.

Interested in joining a true pioneer of medical technology that advances the lives of people worldwide?

Call Diarmuid for more information on +61 2 8096 0060 / dsexton@adroitpeople.com.au

Confidentiality Assured. 

Our client is a leading innovator and manufacturer of pharmaceuticals distributed to global markets. Due to a continued commitment to research and development, and investment in their Sydney operations, an opportunity has been created for a Sterile Manufacturing Advisor to join their team.

The successful candidate will be working with newly developed innovative pharmaceuticals and will be responsible for maintaining the sterility levels throughout the production facility

Responsibilities:

• Audit sterile product batch records and other documentation/reports in consultation with other sterility associates and Quality Managers
• Investigate deviations and review deviation reports for sterile products.
• Ensure root cause/preventative measures are identified and corrective actions are taken.
• Complete internal/external audits of sterile processes
• Review, Investigate and report on batch records, packaging orders and deviations
• Overseeing and managing the company’s compliance to cGMP and regulatory requirements by maintaining updated quality systems and documentation
• Assess overall product quality and process capability using statistical process control
• Providing input into artwork for sterile products, ensuring that all information relating to sterility is agreed and complies with relevant regulatory bodies
• Providing input to Aseptic Reliability team, Continuous Improvement team and Quality team for projects relating to sterile products
• Working closely with Microbiology department to ensure sterility assurance is maintained

Requirements:

• BSc in Microbiology/Chemistry or relevant scientific/engineering discipline
• Min 5 year’s bench experience in sterile environment
• Proven experience managing and monitoring sterility assurance
• Strong communication skills and cross-functional teamwork abilities

Remuneration:

Salary: Excellent dependent on experience

For more information, or to discuss your eligibility for this role, contact Nicola at nbrennan@adroitpeople.com.au or phone 02-80960066

Or apply for this role through http://www.seek.com.au/Job/sterility-advisor/in/sydney-sydney/21562953

Our client is an industry leader in brand name consumer pharmaceutical player with an enviable product portfolio. Due to continued success and sustained growth Adroit People have been retained to secure a Senior Quality Manager for our client’s Melbourne operations.

This is a pivotal leadership role responsible for developing, implementing and managing QA systems and personnel to ensure compliance to corporate and regulatory requirements.

Responsibilities:

• Develop and implement strategies for the continual development of the quality system based on industry best practice and individual analysis of specific needs.
• Lead the QA & QC departments to ensure all functions efficiently operate in accordance with company and regulatory requirements.
• Manage all aspects of laboratory scheduling including raw materials, in-process and finished goods
• Develop and maintain systems to measure performance against established standards
• Plan, implement and manage the training and development of quality personnel.
• Enhance external audit programmes and develop creative approaches to evaluating vendor performance.
• Work with supply partners to improve robustness of overall product supply quality systems and compliance to regulatory standards.
• Build positive working relationships with internal and external customers to ensure QA is recognized as integral to business success and growth
• Foster and promote a quality culture through ongoing education, consultation, leadership, and management review.

Requirements:

• B.Sc. in relevant discipline coupled with proven experience (3+ yrs) in Quality Management positions within regulated industries – pharmaceutical / biotechnology / medical devices.
• Strong knowledge of certified quality driven industry or equivalent experience is highly advantageous.
• Demonstrated experience in successful management of quality teams.
• Excellent problem solving and analytical skills, along with highly developed stakeholder management expertise.
• Proven ability to lead and manage project teams.

Remuneration:
Salary: $ Six Figure Package

For more information, or to apply, contact Diarmuid on 02-80960060 / email: dsexton@adroitpeople.com.au

Confidentiality Assured.

• Dynamic & Supportive Environment
• Specialty Surgical Equipment
• Excellent Remuneration Scheme

Our client is an industry leader and marketer of globally recognised brands that deliver innovative products to clinicians worldwide. Building on their reputation for quality, service and class-leading support our client now seeks Territory Managers to join their NSW operations in an exciting period of the company’s growth and consolidation of market share.

Reporting to the National Sales Manager the Territory Manager will be responsible for maintaining and servicing existing customers, securing new opportunities and delivering solutions to our client’s customer base in Sydney’s metro regions.

Duties in brief:

• Responsible for identifying and securing new business opportunities
• Providing a consultative high level service and support to customers
• Maintaining and developing existing accounts, and developing new relationships with key customers and opinion leaders.
• Manage the portfolio of customers in the assigned territory to grow and manage accounts effectively.
• Prepare, execute and deliver on business plans and budgets while providing superior service offerings to your current and prospective client base.
• Collaborate with team members in the region and nationally to maximise business pathways and opportunities

Requirements:

• Proven sales experience in medical devices/life sciences industry, ideally in operating theatre / surgical setting.
• Ideally, candidates will have a clinical background in nursing or as a theatre technicians, however this is not essential
• You will be expected to achieve sales targets by calling on key decision makers, providing superior service in the form of technical support and in-service training and building relationships based on trust.
• You will need to be comfortable in the theatre environment and comfortable in supporting cases while offering technical advice regarding product.

Remuneration:

$ Negotiable depending on experience

$ Excellent Commission & Bonus Structure that rewards high achievers from the first sale.

For more information, or to apply, call Diarmuid on 02-80960060 / email your application below.

Confidentiality Assured.

• Excellent Career Opportunity
• High Visibility
• Pivotal Strategic Role

Our client is a leading international pharmaceutical developer and distributor of a hugely diverse product portfolio that encompasses prescription, OTC and generic pharmaceutical products. Having established its foothold in the Australian market our client now seeks to further strengthen its strategic clinical input to ensure successful and appropriate commercialisation of their product portfolio.

This is an excellent opportunity for career focused professionals seeking to further their career in a dynamic, rewarding and supportive work environment.

Responsibilities:

• Maintaining records of all adverse event reports and other reportable events in accordance with internal policies and any relevant local or international regulations.
• Provide cross functional support for both regulatory and marketing operations as well as assisting with business development opportunities.
• Gathering, reporting, tracking and following-up adverse events and liaison with cross-functional colleagues regionally to assist in the review of inter-company safety data exchange agreements.
• Provide quality medical/clinical input to product strategy discussions, including commercial, clinical, health outcomes and regulatory aspects, to ensure successful commercialisation of products.
• Coordinate and conduct training and development of staff and sales teams
• Provide technical and clinical support to internal and external customers for current and pipeline products.

Requirements:

• B.Sc. in Pharmacy/Pharmacology or Medical Science with 4-6 years’ experience in a Medical Affairs / Drug Safety / Pharmacovigilance role in biotechnology or pharmaceuticals.
• Superior communication skills – both written and verbal.
• Team focused with ability to work collaboratively across key stakeholder teams.
• Proven ability of working with health professionals across a wide range of therapy areas.

Remuneration:

$ Excellent + Great Benefits + Support

For more information, or to apply, contact Diarmuid on 02-80960060 / email: dsexton@adroitpeople.com.au

Confidentiality Assured.

Our client is a market leader in the development and distribution of medical devices to the global market. With a firm commitment to innovation and best in class quality they are dedicated to improving treatment pathways and standards of living for patients. An opportunity has arisen for a career-minded Health Outcomes Associate to join their Sydney based operations and contribute to the company’s commercial strategy and direction in the region.

This is an excellent opportunity for candidates seeking to further their career in a dynamic and rewarding work environment.

Responsibilities:

• Develop reimbursement strategies and initiates for the region and get to work across a portfolio of products and markets in APAC while being highly visible to the senior management team.
• Act as a business partner to regional business managers and define strategies to address reimbursement constraints.
• Support APAC colleagues to ensure existing reimbursement systems are maintained and enhanced.
• Your input will be required to substantiate superior clinical performance and you will assist in the evaluation of new product concepts.

Requirements:

• You will have experience in health technology assessment and possess strong clinical competency, an ability to look and understand scientific research from a Health Outcomes perspective is ideal.
• A tertiary science/related qualification is required, post graduate studies in Economics, Public Health, Epidemiology or Biostatistics is advantageous but not pre-requisite.
• Ideally you will already have experience of devices reimbursement in the ANZ market but you may also come from related fields in industry, government or academia.
• Familiarity with the reimbursement systems across APAC and / or experience in government relations is very beneficial.
• Flexibility to travel nationally and internationally is required.

Remuneration:
Salary: $Excellent plus benefits.

For more information on this role please contact Diarmuid on 02-80960060 / email: dsexton@adroitpeople.com.au

Confidentiality Assured.

In today’s economy, finding and securing your ideal job can be challenging. For a start, employers are more selective in their hiring processes, and there is plenty of competition vying for the same job opportunities. Many of these will have similar qualifications and experience to you.

Knowing how to present in interview so that you stand out can be tricky. It doesn’t just come down experience and job/academic performance. There is a minefield of techniques and tests that companies use to ‘filter’ through applicants to find the best fit for their open vacancies.

Our Interview Skills Workshop is designed to give job seekers unique insight into the interview process from both the employer and candidate perspectives, and a distinct advantage when it comes to finding and securing their ideal job.

We work with you to help you define and promote your key strengths and attributes, and how to identify where your experience can help you control the interview process.

We give guidance on how to identify opportunities that match your career goals, coupled with training and practical demonstrations that will help improve your performance on the day.

Our Interview Skills Workshop covers:

•CV Preparation and Writing Skills

•Controlling the Interview

•Competency and Behavioural Interview Strategies

•Talking the Talk (Language of the Interview)

•Finding the Right Job For You

•Cover Letters

•First Contact

•Assessment Days and Aptitude Tests

•Working with Recruiters

Individual and Group Workshops available

For more information or to make a booking call us on +612 8096 0060, or email: info@adroitpeople.com.au

Even accomplished professionals can find interviews unnerving. For many it’s like going into an exam where you are the subject matter. You know you’re going to be quizzed on your skills, experience and personal attributes, but you can never be entirely sure what is going to come up on the day.

The key to success is preparation. Here are a few tips to help you get ready for the event:

Study Up

Employers expect you to arrive at the interview knowing background information about their organisation. As an absolute bare minimum, read your prospective employer’s ‘About Us’, ‘Products/Services’ and ‘Careers’ website sections.

Prepare Questions

Formulate intelligent and appropriate questions to ask in your interview. Annual reports are great for swotting up on company histories, recent performance and challenges. Also research competitors and the wider business sector.

Prepare Examples

Skilled interviewers pose intelligent questions to assess your technical or professional knowledge, and your personal attributes. Read the job description and prepare examples for particular competencies deemed essential for the role.

Start Rehearsing

You may feel awkward rehearsing out loud, but its the best way to prepare for an interview, and to perfect your presentation.

Handling Competency Based Questions

Competency, or behavioural, based interview questions are designed to assess an individual’s personal attributes based on their handling of past situations. Unlike traditional interview questions, the focus is on examples of how you dealt with a particular incident and demonstrated a desired attribute.

Base answers interview questions on specific experiences and detail how you handled the situation. Avoid phrases like: “We normally deal with those situations by…”. Instead say: “We had a situation like that three months ago. I was working on a cross-functional team project when…”

Structured answers are key to successfully answering competency based questions:

1. Situation

Give a little background on the situation you’re about to discuss. This provides perspective and grounds the example in reality for the interviewer.

2. Approach

Describe how you approached the task – who did you consult, what research did you do, etc before deciding on a course of action

3. Action

What you did to execute your plan.

4. Result

Outline the achievement of a positive outcome to the situation.

Finally, keep your answers light on technical jargon and excessive detail. If an interviewer wants more detail they will usually ask for it.

Questions

Finally, don’t forget to ask questions when invited to do so at the end of the interview. Basic information may have been given during the interview, but this is your chance to demonstrate that you’re a better than average candidate.

Ask intelligent questions that demonstrate depth of understanding of the position, company, or impacts of the wider market. By showing an active interest in the role and company it will help you go that step further than others to impress prospective employers.