**GCP background and experience identifying risks and managing compliance related to clinical trials/Clinical Trial Experience is key**
**Lifecycle of clinical study is key**
Who are we?
We Are PRA.
We are 20,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting life-saving drugs into the hands of those who need them most.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What do you need to have?
- A Bachelor of Science (BSc) or Arts (BA) degree or equivalent degree is required. A minimum of 8 years experience in a medium to large scale matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R&D area is required.
- Requires knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques
- Ability to interpret data to develop action plans to improve business.
- Must have strong personal leadership with demonstrated competency interfacing with all levels of the organization including senior leaders, strong networking and relationship building skills, ability to create an open and inviting environment, embraces generational differences, with exceptional written and verbal communications skills.
- Experience in R&D process requirements to successfully drive Q&C productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis.
- Ability to translate data into information and strategies into executable action plans.
- Minimum of 8 years of progressive business experience, with exposure to the pharmaceutical R&D environment.
- Ability to motivate professional colleagues and stakeholders.
- Conflict resolution/management and negotiation skills.
- Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
- Experience of the key customers’ business processes and practices; experience of the overall drug development process is an asset
- Knowledge of the overall drug development process.
- Strong working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.
- Experience with regulatory submissions (NDA, BLA).
- Good knowledge of English is required.
- Proficient in Microsoft Office applications.
- Problem solver, proactive strategic thinker, strong leader and collaborator, highly committed to quality, flexible and persistent, good conflict handling and negotiation skills.
- Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks.
- Excellent knowledge of English is required including communication, presentation, interpersonal, and diplomacy skills. Stakeholder contacts are frequent and require excellent interpersonal skills and diplomacy.
- Proficient in Microsoft Office applications.
- Able to create win-win situations with internal and external partners.
- Knowledge of the corporate structure and culture.
- Requires little supervision and functions independently. Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
What will you be doing? Services Overview:
- Develops and maintains quality monitoring plans for assigned programs. Executes and/or oversees implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
- Ensures agreed upon deliverables are completed within the timeframe established, including but not limited to, review and assessment of Quality Risk Management reports; coordination of quality risk mitigation plans for identified issues; quality reviews of key clinical trial documents, and review and planning of submission activities as needed.
- Supports Due Diligence activities, as requested, liaising with the applicable business and R&D Q&C, L&A coordination personnel.
- Provides Good Clinical Practices (GCP) guidance to workgroups and to business partners.
- Ensure interpretation and consistency with compliance guidance provided. Assists in the facilitation of inspections by regulatory authorities for GCP, supporting R&D Q&C as appropriate.
- Develops Quality Monitoring Plans and performs/oversees performance of qualitymonitoring activities for assigned projects or other projects/tasks, as assigned, accordingto agreed upon deliverables and established timelines.
- Provide ongoing compliance support to business partners, including but not limited to:
- Preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk. Collaborates with applicable team members to develop risk mitigation plans.
- Providing compliance support in the management and implementation of quality risk mitigation and inspection readiness actions identified following QM&C assessments for assigned programs.
- Collaborating with the Clinical Team business partners to share audit/inspection observations for lessons learned across protocol, and/or program, and working with the appropriate business partners and appropriate groups within RD Q&C to implement Corrective Action Plans (CAPAs).
- Provide compliance direction/support to applicable clinical team members on an ongoing basis.
- Performs quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities.
- Supports the facilitation of inspections by health authorities for GCP, in liaison with RD Q&C as appropriate.
- Supports special projects, as assigned by supervisor. May mentor new employees.
- Provides appropriate QM&C support to assigned cross-functional workgroups.
- Responds independently to GCP-related compliance inquiries from other departments. Confers with quality professional staff when contacted for pro-active consultation to provide regulatory insight.
- Manages inspection preparation activities and supports business during health authority inspections, in liaison with R&D Q&C as appropriate