Senior/Principal Optimisation Specialist – RA PSO – UK
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
In this role, you will serve as subject matter expert to design, develop, deliver and improve products, programs, and services in order to optimize processes, behaviors, performance and audit readiness. You will be accountable for assigned initiatives aimed at supporting and/or ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications, and interpret data on complex issues, leading teams and making good business decisions with support.
So what does RA PSO team get involved with?
• Be a part of a team that drives continuous improvement
• Procedural management to ensure our procedures are accurate and up to date
• Interpretation and application of regulations as it applies to our business
Correction; Corrective Action & Preventative Actions (CAPAs) for NCQE and CQE originating from a process non-conformance or audit/inspection report management:
• Facilitating CAPA responses to CQE and audit/ inspections
• Authoring and providing true root cause analysis for select Quality Events
• Assure measurements are in place to prevent recurrence
Compliance metrics and monitoring:
o Collating and providing reports on departmental Key Performance Indicators (KPI)
o Trending and providing solutions to reduce risks for our department
o Support content creation
o Learning management assignments
o Support training compliance needs for RA
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 5 years).
Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.
Knowledge, Skills and Abilities:
• Thorough understanding of procedural documents
• Strong understanding of process improvement fundamentals
• Solid investigative and analytical skills
• Strong negotiation skills
• Thorough understanding of clinical management technology and systems, and strong computer skills
• Effective judgment, decision making, escalation, and risk management skills
• Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
• Strong interpersonal skills and problem-solving ability
• Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
• Strong attention to detail
• Thorough understanding of regulatory guidelines and directives
• Strong creative and critical thinking skills
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 have an extensive 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.
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.
**Job:** **Regulatory Affairs*
**Title:** *Senior/Principal Optimisation Specialist – RA PSO*
**Location:** *GB-GB-Cambridge-Cambridge GB Granta Park1*
**Requisition ID:** *171285*
**Other Locations:** *FR-FR-France, NL-NL-Bennekom-Bennekom NL Bornweg 12c, BE-BE-Brussels-Brussels BE St Stevens Woluwe, GB-GB-Winchester-Winchester GB 1-2 Crown Walk, GB-GB-Bellshill-Bellshill GB Fleming House 1*
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group