Careers in UK

DEVELOP YOUR CAREER WITH PPD

Please see our list of current vacancies in the UK below.

For more information, or to apply for any position, please contact us at recruit.uk@europe.ppdi.com and include your CV in Word format, salary requirements and an indication of the position in which you are interested.

Biostatistics Manager – Winchester

Providing a consultancy service on a variety of Biostatistics and multifunctional projects, you will oversee the statistical aspects of clinical trials from design through analysis and reporting. Representing the Biostatistics department in interactions with client companies and regulatory agencies, your responsibilities will include managing a growing team of statisticians and statistical programmers and organising the distribution of work. Furthermore, you will have budgetary and overall responsibility for managing projects and ongoing recruitment within your team. You will also contribute to the management team responsible for the strategic development of the Biostatistics department.

You’ll need a global perspective on your work, a team orientated approach and highly developed interpersonal skills to communicate at all levels. With our growth, scale and reputation for quality, we can offer you a variety of opportunities for a challenging and rewarding career.

To be successful in this role it is essential that you have a proven track record of managing a team and strong interpersonal skills to communicate with colleagues both internally and externally across different levels and disciplines. You must have a degree in Statistics and previous experience of statistics in a clinical trial environment.

Graduate Statisticians - Cambridge/Bellshill, Lanarkshire/Winchester

Working on behalf of major pharmaceutical, biotechnology and medical device companies in support of clinical trials, you will liaise closely with multidisciplinary project teams; gathering, analysing and interpreting data. It is a crucial and varied job. Our fast track training programme will help start your career.

With our growth, scale and reputation for quality, we can offer outstanding scope to progress and develop your career. If you've got what it takes, we'll happily invest in your future. A degree or Masters in Statistics, Mathematics or a similar field is essential, but what we'll also be looking for is your ability to interact with others and understand the wider picture. After all, it's all about converting your learning into something practical and valuable so that you can make a difference.

Graduate Statistical Programmers - Cambridge/Bellshill, Lanarkshire/Winchester

Trainee Clinical Research Associate - Bellshill, Lanarkshire

Every day we’re taking on interesting projects, expanding our facilities and focusing on quality. And every day our workforce is growing. We’re constantly looking for talented people and giving them what they need to grow. We are currently recruiting for our Accelerated CRA training program at our Bellshill office, on the Strathclyde Business Park, near Glasgow.

The Accelerated CRA program commences with three to four weeks of intensive class-room based training, followed by an internally run examination. After this, we work to resource you as a new Clinical Research Associate onto our projects.

As a CRA you will be part of a global project team. You will serve as the primary contact for investigational sites that conduct clinical trials in the UK, performing and coordinating all aspects of the clinical monitoring process from ‘start up’ through ‘interim monitoring’ to ‘close out’.

You will have a life sciences degree or nursing qualification plus some experience of Phase II to IV trials. You will have knowledge of ICH GCP requirements and ideally some knowledge of local ethics and regulatory requirements. If you have previously worked as a Study Co-ordinator, Research Nurse or Clinical Trial Administrator we would especially like to hear from you!

You will be self-motivated with excellent communications and organisational skills. You will be able to prioritise, thrive under pressure, and be comfortable working within a multi-national team environment. Your computer skills will be strong, and you will be able to understand the wider picture.

To apply, please send your CV in Word format, plus a covering letter telling us why you are interested in joining PPD by email to Human Resources

Clinical Research Associate/Senior Clinical Research Associate - Cambridge, Winchester or Bellshill, Lanarkshire

You will be primarily tasked to set up and monitor clinical trials conducted in the UK as part of international projects. You should thrive in multi-national project teams and be focused on delivering exemplary levels of customer service.

With a life sciences degree or nursing qualification and at least one year's experience of Phase II to IV trials, you will have in depth knowledge of FDA and ICH GCP requirements.

SCRAs will have a minimum of two year's experience, including experience of start up, monitoring and close out. As a SCRA you will have the opportunity to mentor more junior CRAs and may be asked to take on project co-ordination activities as a lead CRA.

Project Assistant - Cambridge, Winchester or Bellshill, Lanarkshire

As a Project Assistant you will provide vital support for clinical research projects. You will have excellent communication and organisational skills and a self-motivated, flexible, and professional attitude. You must be able to prioritise and work well within a multi-national team environment and have an in-depth knowledge of Microsoft Word, Excel and preferably PowerPoint.

Project Assistants will have a good standard of education and two years administration experience.

Contracts Co-ordinator - Cambridge

The basic purpose of this position is to support all activities of the Contracts team. The Contracts Co-ordinator will work with Contracts team to assist in the completion and execution of contracts with clinical study sites around the world, with the aim of maximising productivity and contributing to the high quality output of the team.

With proven administration experience ideally within a scientific, pharmaceutical or biotech organisation and excellent language skills, you will have the ability and confidence to communicate effectively and liaise with employees at all levels within the organisation.

You will be joining a truly global enterprise that offers unrivalled variety, exceptional career scope and a caring, supportive culture that nurtures the ability of every individual. We offer a competitive salary and benefits package.

To apply, please send your CV with details of your current salary package and the position you are interested in, to the Human Resources Department at e-mail: hr.uk@europe.ppdi.com

Contract Specialist - Cambridge

Reporting to the Head of Contracts for Europe, your role will be to develop commercial contract expertise within PPD through professional, diligent and proactive contract preparation and advice. The role requires the ability to draft, review and track contracts, utilising your legal and commercial acumen. You will work closely with global project teams to provide them with contract and legal support of a high calibre to meet tight deadlines.

With legal, contracts management, or paralegal experience and an understanding of the principles of contract and intellectual property law, ideally within a scientific, pharmaceutical or biotech organisation, you will have the ability and confidence to communicate effectively and liaise with clients and all levels of management.

You will be joining a truly global enterprise that offers unrivalled variety, exceptional career scope and a caring, supportive culture that nurtures the ability of every individual.

To apply, please send your CV with details of your current salary package and the position you are interested in, to the Human Resources Department at email: hr.uk@europe.ppdi.com.

Assistant Legal Counsel- Cambridge

You will be responsible for commercial (non-clinical) contracts, company secretarial matters, disputes and all ad-hoc legal matters throughout EMEA and Asia. The role includes contract drafting, review and negotiation, liaison with internal clients and external legal and company secretarial advisors and management of the legal fee budget.

You will be a qualified and practicing solicitor with several years PQE. Experience may have been gained in private practice or in-house and in any practice area, but practical experience of analysing legal risk in a commercial context is vital, as well as exposure to international operations.

To apply, please send your CV with details of your current salary package and the position you are interested in, to the Human Resources Department at email:hr.uk@europe.ppdi.com

Associate Director, Clinical Data Management - Bellshill, Lanarkshire

Supporting the Vice President, Clinical Data Management you will provide management and support to all data management processes, ensuring all projects are conducted in accordance with sponsor requirements and PPD Standard Operating Procedures and within budget.

Duties and Responsibilities (according to relevant guidelines, laws and SOP’s):

To provide general support to the European Vice President of Data Management in Europe overseeing and developing data management staff
To participate in the formation and implementation of the strategic development plans for data management both within Europe and on a global basis.
To support department structure through leadership of various functions within the department.
To participate in executive review meetings and deputise for the Vice President of Data Management when required.
To be able to identify improvement opportunities, devise a strategy and implement the necessary tactical activities to achieve the strategy.
To ensure adherence to Company and Department policies and procedures with the group.
To act as Line Manager to a group of Group Leaders across Europe and work on their continued development.
To ensure that all Line Management Team work to the latest Global SOPs and WPDs and to ensure that all Line Management Teams are appropriately trained in these.
To ensure that for each Line Management staff member that there is a training plan in place.
To ensure that there is regular review of each individual member of the team. This should include and assessment of each individual’s contribution, their key responsibilities and training needs. In addition, to ensure that all required steps are taken to deal with non-performance of the Team as a whole, in order to identify areas where quality, efficiency and individual performance can be developed and improved.
To manage all aspects of data management for groups of assigned clients and projects. This includes ensuring the creation and maintenance of detailed project plans for DM aspects of projects.
To identify resource requirements by staff type at project set-up and for the duration of the project, and to ensure that the resource is in place for all assigned projects.
To ensure that for all assigned projects the DM tasks are completed accurately, on time and within budget.
To act as the senior contact for all aspects of data management for assigned clients and projects. This includes effectively liaising with/meeting Sponsors, Project Managers and internal department staff over progress and any technical issues.

With a Life Science Degree or equivalent you will have a minimum of 8 years experience of Data Management in the clinical research field, including 5 years management experience. An excellent track record in Strategic Management in a Data Management role is preferred, including driving the management of change to raise the performance of a Data Management activity to the highest level. Planning and budgeting experience at a senior level is a key requirement.

For more information or to apply for this position, please send your CV and covering letter in Word format to recruitdm.sm@europe.ppdi.com

Clinical Data Associates - Bellshill, Lanarkshire

You will be responsible for performing a wide variety of data management activities from study set-up to database lock. Reporting to a Clinical Data Manager you will have the ability to work as part of a team producing high quality work within tight deadlines.

You will be educated to degree level in life sciences or a related subject/and or relevant experience. Various opportunities also exist to progress to different levels within this role.

For more information or to apply for this position, please send your CV and covering letter in Word format to recruitdm.sm@europe.ppdi.com

CASCADE Business Support Specialist (Maternity Cover) - Cambridge

The CASCADE Business Support Specialist will be a part of a dynamic and growing team within the CSG department. You will provide telephone and computer support to the users of our proprietary clinical trial management system (CASCADE). These users can be based throughout Europe.

Tasks will include liaising with users to resolve their issues via telephone and email; using the IT helpdesk system to track and update support issues; ad hoc coaching on specific areas of system functionality; Technical administration, system and user maintenance.

You should have excellent communication and organisational skills, be flexible and adaptable with the ability to work under your own initiative. You must be IT literate and experience of using a clinical trial database such as Siebel clinical would be advantageous.

Group Manager, Clinical Data Management - Bellshill, Lanarkshire

With the continued growth and expansion within our organisation, we are looking for a Group Manager in our European Clinical Data Management Department.

This exciting role will provide the opportunity to be involved in the provision of operational and financial oversight for allocated projects, both Global and European. As Group Manager you may perform a Project Management role for studies with associated services, or act as Franchise Manager for clients.

You will provide supervisory functions for Clinical Data Management personnel, including performance management and staff development

You will assist Clinical Data Management Senior Management with the formation and implementation of strategic development plans for Clinical Data Management, Europe.

To be successful in this role you must be able to apply knowledge and skills in a highly organised fashion, adhering to regulatory guidelines, SOPs and client expectations. You should be able to demonstrate strong customer focus and excellent interpersonal skills. As Group Manager you should be prepared to travel as required and have a flexible and adaptable approach.

A Life Science Degree or equivalent and extensive experience in Clinical Data Management is required. Other relevant experience would be considered. Proven supervisory experience is essential.

To apply, please send your personal CV along with a covering letter stating why you think you should be considered for this position to:- recruitdm.sm@europe.ppdi.com or by post to: Human Resources Manager, PPD, Bertram House, Kersewell, Carnwath, ML11 8LF

Clinical Data Manager - Bellshill, Lanarkshire

You will be responsible for running your own studies and organizing the full range of data management services in an exciting and challenging environment.

Responsibilities will include managing studies, co-ordinating a team of clinical data associates and processing technicians, resources and budgets, and assessing study activities in comparison to project milestones and timelines.

You will be educated to degree level in life sciences or a related subject and/or relevant experience. The ability to communicate effectively within the project team and to sponsors on operational issues is essential.

Assistant Accountant - Cambridge

This role assists UK Local Accountant to maintain trial balance reporting as part of the monthly cycle. It is a temporary role but may lead to permanent appointment.

The duties include the following:

Control Fixed Asset register and sub ledger including the transfer of assets between stock and the asset register.
Control Cash Book sub ledger including the review of daily bank recs and production of month end bank recs.
Produce daily cash flow forecast
Reconcile intercompany ledgers
Reconcile prepayment accounts and recommend monthly drawdowns
Reconcile accrual accounts as required and recommend monthly accruals and releases
Prepare VAT, Intrastat and EC sales list returns
Monitor CAPEX spend against authorized budgets.

The successful applicant will have a GCSE/O Level grade C or above in English and Mathematics plus at least four others - A Levels are preferred. They will also be a part qualified student with CIMA or ACCA. They will have a knowledge of Excel to macro/pivot table level and working knowledge of an ERP/Accounting system, the ability to produce a set of accounts to trial balance level and demonstrate an understanding of UK, US or IFRS GAAP. They will also have good interpersonal skills to include liaising with non Finance staff. They will have experience in an Accounts Assistant type role. Experience working in a multi currency environment would also be helpful

Payments Clerk - Cambridge

Reporting to UK Finance Manager, this role reviews all payments outside of north and south America and is the first level of Bank Signatory. The responsibilities include the following:

Reviewing UK payment runs to ensure that payment reports match the backup documentation provided (vendor, invoice number, amount, currency etc).
Ensuring that all invoices paid have been properly authorized in accordance with published PPD polices.
Reviewing all non-UK rest of world payment runs to ensure that payment reports have been properly authorized in accordance with published PPD polices.
Liaising with the Payment Clerk and Accounts Payable team to resolve any issues.
Providing first level of bank signatory approval of all payments.
Sending all direct deposit payments using electronic banking software as appropriate.

The successful candidate should possess the following:

Excellent organisational skills
Capability to understand and work with different currencies
An ability to fit into a team
Hard Working and conscientious
Excel skills
GCSE (or equivalent) Maths and English - Grade C and above
Prior knowledge of the Nat West Bankline electronic banking software would be advantageous but not essential.

Experience in an Accounting/Finance/Banking environment preferably with exposure to payment cycles or large value cashier transactions is also required.

F,P & A Analyst - Cambridge

The primary responsibility of the Financial Planning and Analysis team is to understand the forces driving the performance of the business. This knowledge is used to evaluate historical performance and use this knowledge to forecast future results. The team is responsible for EMEA and Asia regions. There is a requirement to prepare ongoing management information as well as ad-hoc reporting.

The FP&A team works with both finance and non finance department heads within the business and communication skills are therefore essential. An analytical mind and high level of numeracy are vital to succeed in this role. The team is very dynamic and provides great opportunities for progression within the FP&A team and the wider finance function. You will need to be educated to degree level or AAT qualified. You will also need good IT skills, particularly Excel.

In House Recruitment Specialist

A rare opportunity has arisen for an experienced In House Recruitment Specialist to join our thriving global contract research organization. Based out of the easily accessible Granta Park, just south of Cambridge, you will be joining at a exciting time in our companies evolution. Reporting directly into the Recruitment Manager you will form an integral part of a team tasked with developing and defining Recruitment strategies across the EMEA region.

As a member of our EMEA Recruitment team, your duties will encompass the full Recruitment lifecycle from internal hiring manager engagement, creative sourcing strategy development and CBI delivery through to on boarding of new colleagues. Ideally from a Professional Services in house recruitment environment, we offer the opportunity to help you build on your best practice recruiting experiences, share your ideas and help to shape our department with your innovative & proactive approach.

Senior/Medical Writers - Cambridge

You will be responsible for researching, writing and project managing scientific documents e.g. protocols, final study reports, IMPDs and other regulatory documents covering a wide range of therapeutic areas for clients and regulatory agencies.

A Life Sciences graduate with experience of writing for clinical research and regulatory submissions, you will have a good understanding of full drug development concepts, the ability to interpret medical data, strong PC skills (including Word) and a clear presentation style.

Medical Writing Manager - Cambridge

You will be responsible for researching, writing and project managing scientific documents e.g. protocols, final study reports, IMPDs and other regulatory documents covering a wide range of therapeutic areas for clients and regulatory agencies. The role also involves line managing a team of medical writers.

A Life Sciences graduate with experience of writing for clinical research and regulatory submissions, you will have a good understanding of full drug development concepts, the ability to interpret medical data, strong PC skills (including Word) and a clear presentation style.

Project Analyst - Cambridge

You will be responsible for project-related reconciliations including revenue recognition, forecasts, invoicing and variance analysis with respect to profitability on PPD’s clinical studies projects. Key responsibilities include liaising with multiple Project Managers across Europe and managing the day to day financial integrity of the projects.

Ideally you will be studying at CIMA Managerial level or equivalent ACCA qualification, able to work to tight deadlines and to communicate clearly and concisely. Excellent MS Office skills (particularly Excel) are also required. Relevant experience of project analysis or a similar position requiring project accounting skills would be an advantage.

You will be joining a truly global enterprise that offers unrivalled variety and exceptional career scope.

Contracts Modifications Analyst -Cambridge

The Contracts Modifications Analyst proactively facilitates and leads contract modifications on behalf of PPD, by ensuring that any changes to the scope in contracts are accurately calculated in financial terms. This involves working closely with Project Analysts and Project Managers to ensure that contract modifications are prepared and approved in an efficient and timely manner.

You will be of Graduate calibre and be able to demonstrate analytical thinking, well-developed numeracy skills and financial awareness. You will have had experience working with individuals at all levels within an organisation and developing quality documentation to meet tight deadlines. Previous experience of costing and business analysis would be an advantage.

You will be joining a truly global enterprise that offers unrivalled variety and exceptional career scope. Please see our website for further details at www.ppdi.com.

To apply, please send your CV along with details of your current salary package, to the Human Resources Department, PPD, Granta Park, Great Abington, Cambridge CB21 6GQ. Email: hr.uk@europe.ppdi.com

Facilities Project Assistant - Cambridge

PPD Development is a world leader in clinical research and a truly global, entrepreneurial company. With more than 9,100 professionals in 28 countries around the world, we deliver excellence and innovation to international pharmaceutical and biotechnology partners. We also value the contribution of every single employee, and provide unrivalled opportunities for personal and professional development.

Reporting to the Facilities Project Manager, this role will undertake administrative support to the Facilities Director and Facilities Managers working on property and projects across the EMEA region. Working as a key member of the Facilities team based in Cambridge, this role will act as a central co-ordination point for projects and will positively contribute to the efficiency and delivery of the department’s workload.

Duties will include the following:

Providing administrative support to Senior Facilities Managers and Project Managers, for example arranging meetings, communicating with local Facilities staff, establishing project files, chasing information requests to suppliers
Raising and subsequently tracking of CARs / purchase orders, in collaboration with Finance team
Co-ordinating regular progress reports for use in Facilities reports, communication updates, project commitments
Organising and collecting performance statistics on Facilities Department activity
Undertaking general office administration and filing
Acting as a central contact point for project enquiries.

The successful candidate will have:

5 GCSEs or the equivalent including English language and maths
General administrative experience working for multiple managers, ideally within a facilities related department
Proficiency in Microsoft Office suite
Good organisational and workload prioritisation skills
Ability to develop creative, innovation solutions to administrative problems/requests
Good communication skills, both verbally and visually
Strong customer service skills
Good comprehension of spelling / grammar
Experience of office administration, ideally within in facilities or property industry
Hands-on experience of running a reception desk, receiving and dispatching couriers, switchboard activity

Project Management Opportunities - Cambridge/Bellshill, Lanarkshire/Winchester

Our sustained year on year growth at PPD means that we are looking for Project Managers to join our rapidly growing teams at our offices in Cambridge, Glasgow, Winchester, Brussels, Paris and Munich.

What is most significant about our recruitment activities is the breadth of project management experience we’re looking for. We need individuals with varying degrees of experience to take on European and Global project management, programme management and product development roles.

Our Project Managers lead and are accountable for time, cost and quality targets and resource and budget control. To achieve this, candidates must not only possess the appropriate project management experience but also the drive and enthusiasm to share and apply their knowledge to the diverse and challenging projects we manage for our clients. In return, you will have excellent career opportunities and Project Managers who fit the required profile can benefit from the option of being home or office-based.

Safety Specialists - Cambridge and Bellshill, Lanarkshire

As part of our expanding pharmacovigilance department, you will be a key member of our European team working closely with a pharmacovigilance team manager to provide effective pharmacovigilance services throughout project lifecycles. You will have the opportunity to work on all phases of patient-based drug development from a wide variety of therapeutic areas.

You will possess a life sciences degree and some experience either in pharmacovigilance or in a clinical research setting. Excellent interpersonal, team playing and communication skills are all prerequisites for this position.

PVG Managers - Cambridge and Bellshill, Lanarkshire

You will have overall responsibility for the planning, co-ordination and delivery of a variety of research projects through your team of Safety Specialist, and in collaboration with other PVG managers, Lead Safety Specialist and senior staff globally, you will help develop consistent internal processes ensuring a quality service is delivered.

As a part of the role, you will provide accurate forecasts for all projects and ensure timely progress by monitoring study metrics. You will also be actively liaising with the Project Manager and Sponsors to ensure optimal performance and utilisation of the PVG project team.

To be successful in this role it is essential that you have a proven track record of managing a team and strong interpersonal skills to communicate with colleagues both internal and external of difference levels and disciplines.

We are looking for proactive and motivated individuals who thrive in a demanding and stimulating environment. You must have a life sciences degree, nursing qualification or other relevant degrees with previous pharmacovigilance/drug safety experience within a pharmaceutical, clinical or health care setting.

You must have a life sciences degree, nursing qualification or other relevant degrees with extensive Pharmacovigilance/drug safety experience within a pharmaceutical, clinical or health care setting.

Principal Safety Specialists - Cambridge and Bellshill, Lanarkshire

As a Principal Safety Specialist you will be responsible for the overall co-ordination, development and delivery of PVG services for large complex studies, overseeing the budgets and supervision of junior colleagues working on the project. You will be working closely alongside the Pharmacovigilance Manager and senior staff globally to help develop consistent internal processes and ensuring a quality service is delivered.

In your capacity as a Pharmacovigilance/drug safety expert within the department it is essential that you possess advanced knowledge of current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues. You will be accountable for ensuring that the project team is managed effectively by working with the Pharmacovigilance Manager to ensure that there is sufficient resource for the assigned projects.

We are looking for positive individuals with a ‘can do’ attitude who focus on finding solutions to enhance the processes. This role is ideal for technically minded individuals with a passion for Pharmacovigilance/drug safety looking to utilize and expand their therapeutic knowledge and expertise to manage processes rather than people.

You must have a life sciences degree, nursing qualification or other relevant degrees with extensive Pharmacovigilance/drug safety experience within a pharmaceutical, clinical or health care setting.

QA Manager - Cambridge

Your primary responsibilities will be to schedule and conduct audits for a range of PPD's clients and to perform internal facility and system audits across all PPD operations. You will have interactions with key players and operational managers, and represent the quality function to our clients. As a senior member of the group you will mentor auditors and assist the Executive Director with planning of audit programmes, review of results from all audit types and recommend improvement strategies. You will also play a key role during client audit and regulatory inspection activities.

You will need a passion for quality combined with excellent communication and interpersonal skills. You will be a life science graduate with experience of multi-national clinical studies in pharmaceutical or CRO business environments and experience in Quality Assurance.

All applicants will require a working knowledge of the background and application of GCP, basic business computer skills (MS Word, Excel, e-mail, etc) and a full driving license.

QA Auditor - Cambridge

Whilst your main audit activities will initially be project based, primarily performing site audits, you will also take part in system based audit programmes. As your career develops, and under the mentorship of a QA Manager, you will have opportunities to develop your skills and eventually have the ability to lead a wide range of audit activities. You will play a vital consulting and problem solving role for the clinical project teams. You will support client audits and regulatory inspections and contribute to PPD's ongoing quality improvement programmes.

You will need a passion for quality combined with excellent communication and interpersonal skills. You will be a life science graduate with experience in Quality Assurance and previous experience in clinical research (CRA, Project Manager or a related field).

All applicants will require a working knowledge of the background and application of GCP, basic business computer skills (MS Word, Excel, e-mail, etc) and a full driving license.

Regulatory Affairs Executive and Senior Executive – Cambridge

We are also looking for additional Regulatory Affairs Professionals to join our central strategic team in Cambridge due to our continuing growth. You will be responsible for providing regulatory strategy advice to internal and external clients and will provide project specific regulatory services and co-ordination of various projects which may vary in size and be on a National, pan-European or global basis.

Key aspects of your role will be to prepare regulatory submissions in Europe, South Africa and Pacific Rim, to assist in business development and pricing of projects for Regulatory Affairs in the company and to provide regulatory advisory and training services for regulatory affairs in the company.

You will have experience in a broad range of Regulatory Affairs issues ideally gained within the CRO or Pharmaceutical industry.

Regulatory Affairs Manager - Cambridge

Due to an increase in workload we are looking for a Regulatory Affairs Manager to be based in our office in Cambridge. You will be responsible for providing timely, accurate regulatory advice on strategy and will manage projects in the provision of regulatory affairs services. This will involve you liaising with internal and external clients in the provision and marketing of these services.

A key aspect of your role will be to take primary Regulatory responsibility for effective interactions with the Authorities to support local/central functions and assigned activities. You will also be expected to build and maintain local, central and external relationships in order to influence the regulatory environment, particularly those within Europe.

You may also be required to supervise other regulatory affairs individuals depending on business need.

You will have experience in a broad range of Regulatory Affairs issues gained within the CRO or Pharmaceutical industry. Extensive knowledge of regulatory applications and procedures, especially those related to clinical trials, along with proven success in agency influencing and negotiation, would be an advantage.

Associate Director Regulatory Affairs - Cambridge

Due to our continued growth we are looking for an Associate Director for the Regulatory Affairs team. This role is based at our European head office in Cambridge and will be responsible for providing direct management and support to members of the Regulatory Affairs Strategic team in Cambridge. A key aspect of this role is that you will act as the “Executive” contact for the sponsor to oversee and ensure all aspects of Regulatory Affairs are conducted in accordance with their requirements. You will also be responsible for all budgets and contracts in relation to your assigned projects.

This position directly relates to the development and securing of new business opportunities, and the day to day operational management of assigned regulatory services in accordance with contract, all applicable regulatory requirements and laws, and sponsor/PPD policies and procedures.

You will be able to demonstrate good in-depth knowledge in either the preclinical, CMC or clinical environment and have the ability to motivate and integrate teams and teach/mentor team members.

You should have broad Regulatory Affairs experience, excellent knowledge of ICH and European/ROW Regulatory Procedures, including both clinical trials and product licensing and proven success in agency influencing and negotiation. Direct experience of successfully managing a team of Regulatory Professionals would be an advantage.

Flag Page Manager

As Flag Page Manager you will direct the development and maintenance of the PPD Flag Pages, ensure Flag Page Owners are trained on WPD-CL-40, Flag Page Management. Ensure timelines are met and provide follow-up with appropriate parties, review of all Flag Pages prior to submission to Flag Page Quality Controller to ensure the content and format are appropriate for submission. Track annual review status of Flag Pages/linked documentation in a suitable tracking log, provide weekly updates of the Flag Page Tracker to Flag Page Quality Controller, forward new information/regulatory intelligence to the Flag Page Owner for possible Flag Page revision and act as a Flag Page Gatekeeper. Other duties related to regulatory intelligence as assigned.

You must have a Bachelor’s degree or equivalent combination of education and experience and 2-4 years previous regulatory affairs experience (depending on education level) would be preferred.

Technical Operations Analyst – Bellshill

As a member of the Technical Operations team, you will provide Oracle Clinical database and systems support to our European Data Management group.

Working on varied client projects you will be an integral member of the multi-disciplinary project teams, providing technical support on several system and applications. The growth of the team will generate opportunities to contribute to various departmental programmes and initiatives including process streamlining and tool assessment/development.

We are looking for motivated and flexible team players who enjoy a challenge. You will have strong communication skills and an ability to produce high quality work within tight timelines. Qualifications in a Computer Science related field and relevant experience in Oracle Clinical or other Database Management systems is desirable. Experience of working in a clinical research environment is essential.

To apply, please send your CV with details of your current salary package and the position you are interested in, to the Human Resources Department at email: hroperations.sm@europe.ppdi.com

For more information about these roles and what PPD can offer you, please visit our website at www.ppdi.com/careers

We are also interested in speculative applications.

If you are interested in any opportunites with PPD, please send your CV, with salary requirements and an indication of the position in which you are interested, to:

recruit.uk@europe.ppdi.com

or

Human Resources
PPD
Granta Park
Great Abington
Cambridge, CB1 6GQ
United Kingdom
Tel: +44 1223 374100
Fax: +44 1223 374133