Country Approval Specialist

2 hours ago

Melbourne, Australia Thermo Fisher Scientific Full time

PPD is recruiting for our growing Australian study start-up team. As one of the world's largest CRO's, our CRA's have the opportunity to work on challenging projects across a wide range of therapy areas with some of the most innovative pharmaceutical and biotech companies in the world

PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading company amongst CROs and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company.

Currently we are recruiting for a dual role for Country Approval Specialist/Contract Specialist.

**Role duties**:

- Provides Site Selection support for awarded multi-service projects
- Key-contact at country level for either Ethical or Regulatory submission-related activities.
- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
- Developed collaborative relationships with investigative sites and client company personnel.
- Negotiate and finalize site contracts and budgets as necessary
- Maintain regular site contact during the start-up phase and document all communications in CTMS.
- Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process
- Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.

PPD Australia Pty Ltd requires new employees who are in office based or site facing roles to be fully vaccinated for COVID-19 prior to their first working day with PPD Australia Pty Ltd. Office based means employees attending our Melbourne office, whether on a fixed or flexible schedule. Site facing roles means employees in a role that requires attendance at investigator sites as part of their role; Clinical Trial Coordinator, Remote Site Monitor, Clinical Research Associate, Clinical Manager. Employees attending client sites may also need to show evidence of COVID-19 vaccination to gain access to client facilities, depending on the client’s policy.

**Education and Experience**:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 to 2 years') or equivalent combination of education, training, & experience.
- Australian or New Zealand site knowledge advantageous

**Knowledge, Skills and Abilities**:

- General understanding of budget negotiations within Australia
- Basic understanding of contract and Indemnification requirements for Australia
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

**Our offer**: As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company. At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position.

Locations we are hiring in:

- Home based Australia

LI-Remote

  • Country Approval Specialist

    4 weeks ago

    Melbourne, Australia Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Materials Specialist

    4 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Materials Specialist - Country Road Group**: **Job No.**: 996967 **Location**: Melbourne - CBD & Inner **Job type**: Full-Time **_Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House of Brands. We are investing in new and existing capabilities and have a number...

  • Country Road Apparel Specialist

    5 days ago

    Melbourne, Victoria, Australia Country Road Group Full time

    Job OverviewThe Country Road Apparel Specialist will be responsible for leading the operational execution of the buying strategy for Country Road Womenswear, driving sales and revenue growth through effective product assortment development and management.Main Accountabilities:Market Insights: Gather market insights to inform buying decisions and ensure...

  • Designer - Girlswear - Country Road

    4 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Job no**: 996492 **Work type**: Full-Time **Location**: Melbourne - CBD & Inner **Categories**: Design & Development **Purpose** Design a product range for the Girlswear apparel and accessories range that fulfils the range option plan and that reflects our season trend statements and customer profile. Manage the Design Assistant to achieve cutting edge...

  • Ethical Sourcing Specialist

    4 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Ethical Sourcing Specialist - Country Road Group**: **Job No.**: 997035 **Location**: Melbourne - CBD & Inner **Job type**: Full-Time **_Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House of Brands. We are investing in new and existing capabilities and have a...

  • Country Road Group

    4 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Job no**: 996004 **Work type**: Full-Time **Location**: Melbourne - CBD & Inner **Categories**: Leasing **Purpose** To manage Country Road Group’s Real Estate occupancy costs and lease database (Lease Eagle) as well as file management and providing lease administration support to the business (all brands) as required. Please note, this is a 12 month...

  • Customer Experience Specialist Country Road

    4 days ago

    Melbourne, Victoria, Australia Country Road Group Full time

    Why Work for Country Road?A Great Place to WorkWe are a leading fashion brand in Australia, known for our high-quality designs and commitment to sustainability. As a Sales Consultant, you will be an integral part of our team, working together to deliver exceptional customer experiences.You will be responsible for maintaining a true passion for fashion,...

  • Senior Homeware Specialist

    2 days ago

    Melbourne, Victoria, Australia Country Road Group Full time

    Senior Homeware Specialist - Country Road GroupWe are seeking a Senior Homeware Specialist to manage our product development process for homeware within the Country Road brand. This role will collaborate with buyers, designers, technical designers, and suppliers to bring products to life.The successful candidate will have strong negotiation skills to meet...

  • IT Service Delivery Specialist

    2 days ago

    Melbourne, Victoria, Australia Country Road Group Full time

    As an IT Service Delivery Specialist, you will be responsible for managing vendor relationships and ensuring IT services are delivered effectively, aligned with business needs.Key CapabilitiesDegree in IT Management, Business Administration or similarIn-depth understanding of IT governance, risk management, and compliance with a focus on business-critical...

  • Fashion Styling Specialist

    2 days ago

    Melbourne, Victoria, Australia Country Road Group Full time

    As a Fashion Styling Specialist, you will play a vital role in executing and styling e-commerce web stills shoots, adhering to our e-commerce style guide. You will support in prop sourcing and assist in styling still life shoots, ensuring high-quality images that meet our brand standards.You will also manage photographers on set, achieving agreed daily shot...

  • Online Cx Specialist

    3 hours ago

    Melbourne, Australia Country Road Group Full time

    **Online CX Specialist**: **Job No.**: 997018 **Location**: Melbourne - CBD & Inner **Job type**: Full-Time **_Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House of Brands. We are investing in new and existing capabilities and have a number of exciting...

  • Communications Specialist

    2 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Job no**: 997425 **Work type**: Full-Time **Location**: Melbourne - CBD & Inner **Categories**: Communications **_Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House of Brands. We are investing in new and existing capabilities and have a number of exciting...

  • Soft Goods Design Specialist

    18 hours ago

    Melbourne, Victoria, Australia Country Road Group Full time

    About the OpportunityThe Country Road Group is one of Australasia's largest Lifestyle Brand Houses, comprising iconic brands such as Country Road, POLITIX, Trenery, Witchery, and MIMCO. We are committed to providing a working environment that embraces and values diversity and inclusion.This is an exciting opportunity to join our team as a Soft Goods Design...

  • Digital Marketing Specialist

    4 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Digital Marketing Specialist - Trenery**: **Job No.**: 997193 **Location**: Melbourne - CBD & Inner **Job type**: Full-Time **_Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House of Brands. We are investing in new and existing capabilities and have a number of...

  • Sustainability Specialist

    4 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Job no**: 996499 **Work type**: Full-Time **Location**: Melbourne - CBD & Inner **Categories**: Sourcing/Supply Chain **_Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House of Brands. We are investing in new and existing capabilities and have a number of exciting...

  • Customer Experience Specialist

    4 days ago

    Melbourne, Victoria, Australia Country Road Group Full time

    We're on the hunt for talented individuals who are passionate about fashion and committed to delivering exceptional customer experiences.About Country Road GroupAs an iconic Australian brand, we're famous for our effortless style and quality designs that are made to last.We're a leading responsible retailer, proud to support local partnerships with...

  • Digital Marketing Specialist

    4 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Digital Marketing Specialist - Acquire & Reactivate**: **Job No.**: 997044 **Location**: Melbourne - CBD & Inner **Job type**: Full-Time **_Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House of Brands. We are investing in new and existing capabilities and have...

  • Digital Marketing Specialist

    4 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Digital Marketing Specialist - Politix**: **Job No.**: 997065 **Location**: Melbourne - CBD & Inner **Job type**: Full-Time **_Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House of Brands. We are investing in new and existing capabilities and have a number of...

  • Brand Impact Specialist

    4 weeks ago

    Melbourne, Australia Country Road Group Full time

    **Brand Impact Specialist**: **Job No.**: 997020 **Location**: Melbourne - CBD & Inner **Job type**: Full-Time **_Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House of Brands. We are investing in new and existing capabilities and have a number of exciting...

  • Financial Assistant Specialist

    5 days ago

    Melbourne, Victoria, Australia Country Road Full time

    We are looking for a highly motivated and passionate individual to join our team as an Administration Assistant. This role involves supporting the management of concession product registration and price integrity across channels.Job Description:The successful candidate will be responsible for maintaining accurate product registration and pricing information...