Country Approval Specialist (submissions) - South Africa

PPD

ZA Johannesburg Johannesburg ZA Woodlands Dr

1d ago

Job Description

Country Approval Specialist (Submissions Specialist) - South Africa

PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people.

We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility.

We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

PPD is currently looking for a Country Approval Specialist to join our team in South Africa ideally working form the office in Johannesburg although flexibility may be offered to experienced candidates.

As a Country Approval Specialist, you will :

Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.

g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy

Provide, under guidance local regulatory strategy advice (MoH & / or EC) to internal clients

Provide project specific local SIA services and coordination of these projects

May have contact with investigators for submission related activities

Key-contact at country level for either Ethical or Regulatory submission-related activities

Coordinate, 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

May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable

May develop country specific Patient Information Sheet / Informed Consent form documents

May assist with grant budgets(s) and payment schedules negotiations with sites.

Support the coordination of feasibility activities, as required, in accordance with agreed timelines

Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner

Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs

Maintain knowledge of and understand PPD SOPs, Client SOPs / directives, and current regulatory guidelines as applicable to services provided

Requirements

To be considered for the role of Country Approval Specialist you should have :

Bachelor's degree

2 years related experience or equivalent combination of education, training, & experience

Effective oral and written communication skills

Excellent interpersonal skills

Strong attention to detail and quality of documentation

Good negotiation skills

Good computer skills and the ability to learn appropriate software

Excellent English language skills

Basic medical / therapeutic area and medical terminology knowledge

Ability to work in a team environment or independently, under direction, as required

Basic organizational and planning skills

Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we offer a benefits package based around the health and well-being of our employees.

We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

We are a global organisation but with a local feel.

We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application we’d love to hear from you.

Preference will be given to employees from thedesignated groups in line with the provisions of the Employment Act No.55 or1998 (and any amendments thereto), PPD’s recruitment policy and the EmploymentEquity Plan’.

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