PPD Sr Optimization Specialist - Regulatory Affairs (with SQL, Java programming knowledge) in Spain
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.
We have an exciting opportunity for Senior Optimization Specialist – Regulatory Affairs.
In this role you will collaborate with project or program leads to design, develop, deliver and improve products, programs, and services in order to optimize processes, behaviors, performance and audit readiness. Accountable for assigned activities and initiatives aimed at supporting and/or ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications.
Supports the Regulatory Affairs systems on a global level
Creates varied support materials, presentations, and/or tools to support the department's remit and strategies
Prepares, coordinates and/or delivers working group materials, facilities and communications per established timelines and milestones.
Supports and participates in process improvement initiative teams, and/or may lead simple process improvement initiatives.
Participates in and supports initiatives to develop, optimize, improve and assess compliance with processes and associated systems/applications, training and communications.
Performs special projects, assignments and administrative tasks per business needs.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Strong experience with Regulatory affairs systems
Business analyst experience
Project management experience
SQL, Java & other programming knowledge
Good knowledge of EU and US regulatory regulations
- Veeva Vault RIM knowledge would be ideal
Knowledge, Skills and Abilities:
Firm knowledge of procedural documents
Good understanding of process improvement fundamentals
Good investigative and analytical skills
Solid negotiation skills
Firm understanding of regulatory technology and systems, and strong computer skills
Understanding of safety technology and systems (advantage)
Good 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
Solid interpersonal skills and problem-solving ability
Solid attention to detail
Working knowledge of regulatory guidelines and directives
Good creative and critical thinking skills
Computer systems validation knowledge
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.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
Job: *Regulatory Affairs
Organization: *GB BU
Title: Sr Optimization Specialist - Regulatory Affairs (with SQL, Java programming knowledge)
Location: GB-GB-Cambridge-Cambridge GB Granta Park1
Requisition ID: 189571
Other Locations: Belgium, Romania, Portugal, Czech Republic, Bulgaria, Spain, Europe, Middle East %26 Africa, Slovakia, Netherlands, United Kingdom, Croatia, France, Hungary, Italy, Serbia, Poland, Greece
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
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