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Local Compliance Specialist
3 months ago
- Competitive salary package, flexible work practices, award winning benefits
- Continuous training and development
About the company
At Johnson & Johnson everything we do is engineered with the patient in mind. It drives us to search for new ideas and innovative healthcare solutions. We embrace challenges and develop treatments that will change the lives of our patients.
We are in an exciting period, we are evolving our ways of working to be able to deliver the greatest value for our patients.
We are introducing a number of new positions to strengthen our capability, deliver on our exciting pipeline and to provide the meaningful talent development experiences for our people, to develop them into leaders of the future.
Our GCO team is a center of excellence within Innovative Medicines (the pharmaceutical division of Johnson & Johnson), responsible for clinical trials and other data generation activities to support R&D and Medical Affairs research.
Our current areas of focus are Oncology/Haematology, Infectious Diseases & Vaccines, Immunology, Cardiovascular Disease, and Neurosciences. We also look towards emerging areas of focus, including retinal and rare diseases.
The Opportunity
Reporting to the Local Compliance Manager, you will be responsible for performing activities that ensure an integrated and comprehensive quality compliance approach for clinical trials in GCO.
You will also ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson global processes and procedures.
Qualifications:
- A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 46 years relevant experience equivalent is required.
- A minimum of 3 years of previous Pharmaceutical Industry experience is required, with at least 2 years of GxP experience within clinical research and development and/or quality assurance.
- Knowledge of the overall drug development process
- Developing or developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
- Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
- Ability to translate data into information and strategies into executable action plans improving the business
- Ability to motivate professional colleagues and stakeholders
- Conflict resolution/management and negotiation skills
- Independently plan, organize, coordinate, manage and execute assigned tasks
- Ability to identify issues and exercise judgement in developing new approaches/solutions and resolving issues within immediate area of responsibility and scope
- Experience of the key customers' business processes and practices
- Good working knowledge of FDA/ICH and countryspecific regulations and guidelines related to clinical development
- Experience with regulatory submissions (NDA, BLA) is an asset Travel up to 10% or more as needed
2023 Best Places to Work - #1 in Health Industry
Competitive Salary package, Flexible work practices and award-winning benefits.
You will be rewarded through a competitive remuneration package along with continuous training, support, and award-winning leadership development programs.
Johnson & Johnson can change everything including YOU
At J&J, we are dedicated to addressing and solving some of the most important unmet medical needs of our time.
Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.
Closing date:
Thursday 15th Feb 2024.
Johnson & Johnson is an equal opportunity employer who supports inclusive, flexible and accessible working arrangements for all. This includes persons with disabilities, culturally, religiously and linguistically diverse people, diverse age groups, diverse sexual orientation, and gender.
We are committed to working in partnership with and support Aboriginal and Torres Strait Islander peoples and organisations by recognising and respecting the diversity of cultures, identity, heritage, languages, and social and spiritual systems practiced.
We draw pride and strength from you, your colleagues and the world we care for—all backgrounds, beliefs and the entire range of human experience—coming together to bring health to billions.
As a leading global healthcare provider and in complying with Public Health Orders and customer facility access policies this role requires any applicant to hold and maintain a fully compliant COVID-19 vaccination certificate (or hold a valid exemption).
Agencies please note:
This recruitment assignment is being managed directly by Johnson & Johnson's Talent Acquisition team. We will reach out to our preferred agency partners in the rare instance we require additional talent option
