EU Regulatory Strategist – Regulatory Affairs Jobs

EU Regulatory Strategist required for leading pharmaceutical company based in the South East of England.

Our client, one of the world’s leading pharmaceutical companies is currently looking for an EU Regulatory Strategist to join their team based in the South of England.

Reporting to the EU Regulatory Strategy Portfolio Manager, your role will include:

  • Ensuring EU contribution to Global Regulatory Strategies and implementation plans.
  • Ensuring that the regulatory contributions work towards achieving the objectives in the strategy.
  • Be responsible for providing the required regulatory contributions to project teams, adhering to time and cost deadlines.
  • To liaise with Senior Management regarding regulatory plans.
  • Work closely with the Regulatory Product manager to ensure consistent and appropriate process, working practices and quality standards.

The ideal candidate for this EU Regulatory Strategist role will be educated to a minimum degree level in a scientific subject and will have demonstrable have experience of the following:

  • EU regulations.
  • CTA and MAA submissions process.
  • Management of complex regulatory issues.

If you would like to hear more about this EU Regulatory Strategist job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this EU Regulatory Strategist job

Not quite what you’re looking for? Click here to search for other pharmaceutical jobs now.

CKC01twitterckclinicallinkedinfacebookckclinical youtube

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , , , , , , ,

Clinical Project Manager wanted

Our client is one of the leading world’s leading healthcare companies.  Due to departmental expansion, a new Clinical Project Manager position has arisen. The main focus of this Clinical Project Manager role will be to be responsible for all aspects of allocated clinical trials in Healthcare and / or Personal Care categories.

Working as a Clinical Project Manager, you will provide clinical input to designated projects through the specification of clinical trial requirements and protocols and management of clinical trials. You will work in a multi-functional project teams and will provide clinical input to deliver project requirements, and work with CRO’s, KOL’s and Regulatory bodies to optimise project development strategies.

Further responsibilities of this Clinical Project Manager include:

  • To provide clinical expertise to the design of clinical trials, ensuring trial designs are appropriate to achieve the desired claims and to suggest innovative approaches to achieving the desired endpoints.
  • To ensure that all protocols developed for pharmaceutical clinical trials and cosmetics clinical studies address the business requirements and are fully compliant with all relevant legal and regulatory requirements and SOPs.
  • To ensure that all clinical trials / studies are performed to the required timelines.
  • To ensure that the relevant Clinical Affairs SOPs are implemented for all clinical trials/studies.
  • To be persuasive and influential within the project teams.

The successful candidate for this Clinical Project Manager job will have demonstrable Clinical development experience gained in the pharmaceutical / cosmetic development environment. The ability to work in the EU is a pre-requisite.

This is a fantastic opportunity for the right candidate to develop their career with a fast moving and innovative global healthcare organization.

If you would like to hear more about this Clinical Project Manager vacancy, please contact Jim Gleeson at jgleeson@ckclinical.co.uk or 01438 870027.

Alternatively, apply for this Clinical Project Manager job now.

 

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry.

CKC01twitterckclinicallinkedinfacebookckclinical youtube

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , , , ,

GSK to cut 380 pharmaceutical jobs in Essex

redundancy[1]The global pharmaceutical company, GlaxoSmithKline (GSK) have announced that they will be cutting 380 pharmaceutical jobs at their site in Harlow, Essex. The site currently employs 1,150 staff. The cuts come as projects for pain relief, anxiety and depression drugs come to an end. Despite reporting an annual rise in profits of 12% earlier this year, the pharma company are still stressing the need to make cost savings.

GSK’s CEO, Andrew Witty stated that “Glaxo would discontinue research in some areas including depression and pain, and would focus more on degenerative and inflammatory diseases such as Alzheimer’s disease and Parkinson’s disease.”

 

Glaxo has its headquarters in Brentford, Middlesex, and research bases at Stevenage and Ware in Hertfordshire and Harlow in Essex.

Worried about redundancy? Search for Pharmaceutical Jobs in the UK now.

Posted in General, NewsTagged in , , , , , , , , , ,

Clinical Data Project Manager – Belgium

Clinical Data Project Manager required for worldwide pharmaceutical company based in Belgium.

A Worldwide Pharmaceutical company with offices in Belgium are looking for an experienced Clinical Data Project Manager to join their team. If you are an experienced Data Manager that is looking to explore new cultures, whilst working in a challenging and stimulating environment this might just be the role for you.

In this role you will manage outsourced studies in EDC from set-up to Data base lock, providing Data Management support for Clinical Databases with limited supervision.

Further key responsibilities of this Clinical Data Project Manager job will include:

  • To manage projects according to strict timelines.
  • To manage ‘end to end’ process of outsourced studies.
  • To maintain internal database standards for data reporting in collaboration with CDISC.
  • To specify the study structure and validation according to protocol specifications.
  • To design and study specific eCRFs
  • To produce, co-ordinate and perform user acceptance testing
  • To perform data validation
  • To perform SAE reconciliation where necessary
  • To manage and monitor change requests to eCRF and external databases
  • To develop and maintain working practices
  • To participate in Computer Systems Validation of in-house technologies
  • To maintain study documentation
  • To be the main liaison for all CRO/EDC vendors Essential Key Requirements
  • Several years experience in Clinical Data Management within the pharmaceutical industry
  • Sound knowledge of the drug development process, Data Management process and medical terminology
  • Clean, quality data for statistical reporting Main Demands
  • Ensuring work is compliant with ICH GCP and regulatory requirements
  • Ensuring compliance with 21 CFR Part 11 Electronic Records; Electronic signatures

If yourself or anyone you know might be interested in working in this interesting and challenging position please contact Sarah Brunnen on 01438 743047, or email sbrunnen@ckclinical.co.uk.

Apply for this Clinical Data Project Manager job now.

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry.

CKC01linkedintwitterckclinicalfacebookckclinical youtube

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , ,

Drug Safety Associate – Buckinghamshire, UK

Drug Safety Associate required for top pharmaceutical company based in Buckinghamshire, UK.

Our client, a top pharmaceutical company, are currently looking for a Drug Safety Associate to join their team based in Buckinghamshire. As a Drug Safety Associate, you will be responsible for the receipt and data entry of adverse event reports following Company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies. Previous case processing experience is required.

Further key responsibilities of this Drug Safety Associate role will include:

  • Triage of incoming cases to determine seriousness for prioritisation of daily workflow.
  • Confirmation of Safety Co-ordinator case registry data.
  • Database searches as necessary.
  • Completion of literature searches as necessary.
  • Completion of remaining case data entry, including narrative or auto-narrative.
  • Completion of risk and quality (label, approval, manual coding & quality review steps.
  • Clarification of unclear or illegible information from the LSO or Call Centre.
  • Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician.
  • Completion of protocol request forms as necessary.
  • Preparation of deviation memo as necessary.
  • Request deletions as necessary.
  • Single case unblinding.
  • Understand relevant safety implications regarding contracts with operating companies and/or marketing partners.
  • Review and make suggestions for system and procedure enhancements.
  • Participation in inspections and audits, as required .
  • Participation in local or global project team.

This Drug Safety Associate position will focus on working on an oncology drug, therefore experience in oncology and the Argus database is a desirable. The ideal candidate for this position will also have a Life Science degree or be a qualified nurse.  Pharmacists are not suited unless they have recent experience in Drug Safety.

The successful candidate will enjoy the benefits of working to a global pharmaceutical company, including a competitive rate.

If you would like more information regarding this Drug Safety Associate job, please contact Hendre on Hendre on Tel: +44 (0)1438 870 023 or email hmoolman@ckclinical.co.uk quoting 19282 to indicate your interest.

Apply for this Drug Safety Associate job now.

Not quite what you’re looking for? Click here to search for our other Drug Safety job vacancies now.

CKC01linkedintwitterckclinicalfacebookckclinicalyoutube

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , , , , ,

Local Lead Nurse in Oxford

Our client, an established Medical Devices company, are currently looking for a Local Lead Nurse to join their team in Oxford. This is a field based position in which you will be responsible for providing managerial responsibility of home care nursing services following all the policies and procedures in place. You will be responsible for the co-ordination and management of the nursing rota, and recruitment to ensure patient care is of the highest standard.

The main duties of this Local Lead Nurse job include:

  • Co ordination and management of nursing rota.
  • Patient management.
  • Staff training, development, and supervision.
  • Organising staff meetings.
  • Recruitment of home care nurses.
  • Incident management.

The ideal candidate for this Local Lead Nurse job will have:

  • Nursing experience working with critical care patients.
  • Home care/ community experience.
  • Sound knowledge of IV therapy.
  • Team management experience would be preferable.
  • Previous experience of ICU/CCU and paediatric nursing.

If you would like more information about this Local Lead Nurse job contact Meera on Tel: +44 (0)1438 743047 who specialises in this field. Email: mpattni@ckclinical.co.uk.

Apply for this Local Lead Nurse job now.

 

About CK Clinical

Finding a new job can be a rather daunting process, at CK Clinical we pride ourselves in our honest and supportive approach. This is the reason why nearly 50% of people we help are referred to us by their colleagues and friends. CK Clinical are preferred suppliers to the top 5 global organisations within oursector as well as having agreements in place with smaller, more niche organisations too.

CKC01twitterckclinicallinkedinfacebook youtube

Posted in Featured Jobs, NewsTagged in , , , , , , , , , ,

Medical Advisor – Hertfordshire, UK

Medical Advisor required for an established pharmaceutical company based in Hertfordshire, UK.

Our client, a research based pharmaceutical which specializes in the discovering, development and marketing of products throughout the world.

This innovative pharmaceutical company are currently looking for a Medical or Scientific Advisor to join their team based in Hertfordshire. Working as Medical Advisor, your main responsibility will be to support the Medical Manager In the provision of a comprehensive Medical Affairs service to the company’s therapeutic area of Seizure Disorders.

Further key responsibilities of this Medical Advisor job will include:

  • Providing input at medical issues management meetings.
  • Ensuring compliance with internal guidelines/SOPS, ABPI and IPHA code of practice, contribution and maintenance of SOPs.
  • Providing support to marketing department for product portfolio including copy approval.
  • Responding to medical questions (internal and external).
  • Medical representation of the company locally/regionally including Advisory Boards.
  • Assist in the medical aspects of the induction, training and maintenance of standards of performance of other Department members, where appropriate.
  • Remaining familiar and concurrent with Medicines Act, ICH Guidelines, GCP Guidelines and Clinical Trial Directives.

The successful candidate will hold a medical qualification or a higher scientific degree.  Previous experience in pharmaceutical medicine, possibly within a medical affairs position is also desirable, along with experience of scientific and medical analysis of complex data sets and medical writing. This Medical Advisor role also demands a person with good communications skills as well as a desire to succeed in a commercial environment.

This is a fantastic opportunity for the right candidate to develop their career with a global, fast paced and dynamic pharmaceutical company.

If you would like to hear more about this job, please contact Hendre on 01438 870 023 or email hmoolman@ckclinical.co.uk, quoting 19219 in all correspondence.

Apply for this Medical Advisor job now.

Not quite what you’re looking for? Click here to search for our current pharmaceutical jobs now.

CKC01twitterlinkedinckclinicalfacebook youtube

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , , , , , , ,

AstraZeneca to cut 8,000 pharmaceutical industry jobs

pills

Today, AstraZeneca, one of the world’s leading pharmaceutical companies, has announced that it is planning to cut a further 8,000 jobs across its global operations over the next four years as its targets cost savings of around $1.8 billion.

Having already cut about 12,600 jobs, further job cuts will be made in functions such as sales and marketing, business infrastructure, research and development, and the supply chain.

The group has a number of operations across the UK, including its head office in Macclesfield, Cheshire, and sites in Alderley Park, Loughborough, Bristol, Luton and London. An AstraZeneca spokeswoman said the company had yet to reveal how many UK positions would be affected at these sites.

Search for jobs in the pharmaceutical industry now.

Posted in General, NewsTagged in , , , , , , , , , , , , , ,

Project Statistician based in Surrey, UK

Project Statistician needed to work with a leading pharmaceutical company based in Surrey, UK.

A rare opportunity has arisen for an experienced Project Statistician to work with one of the world’s leading Pharmaceutical companies.  In this role the Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analysing data for these types of studies.

The main responsibilities of this Project Statistician job are outlined below:
Statistical Trial Design and Analysis
•  Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
•  Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
•  Collaborate with data management in the planning and implementation of data quality assurance plans.
•  Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
•  Participate in peer-review work products from other statistical colleagues.
Communication of Results and Inferences
•  Collaborate with team members to write reports and communicate results.
•  Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
•  Respond to regulatory queries and to interact with regulators.

The ideal candidate for this Project Statistician job will be educated to an M.S or Ph.D. degree standard in a Statistics or Biostatistics discipline, or will have equivalent experience, along with proficient knowledge in the SAS programming language. Further competencies required for this role include:
•  Interpersonal communication skills for effective customer consultation.
•  Teamwork and leadership skills.
•  Technical growth and application with working knowledge of experimental design and statistics.
•  Self-management skills with a focus on results for timely and accurate completion of competing deliverables.
•  Resource management skills.
•  Creativity and innovation.
•  Demonstrated problem solving ability and strategic thinking.
•  Business process expertise associated with critical activities (e.g. regulatory submissions).

If you would like to hear more about this project statistician role, please contact Sarah Brunnen at CK Clinical on 01438 743047 or email sbrunnen@ckclinical.co.uk.

Apply for this Project Statistician job now.


Click here to search for other pharmaceutical jobs now.

CKC01linkedinckclinicaltwitterckclinicalfacebookckclinical youtubeckclinical

Posted in Featured Jobs, NewsTagged in , , , , , , , , , , , , , , ,

CK Clinical to Speak at Recruiter Annual Forum 2010

 ck clinical social media

CK Clinical, a leading pharmaceutical recruitment agency handling jobs in clinical research and drug development, has been invited to join the panel of speakers at the Recruiter Annual Forum 2010 which will be taking place on 23rd March 2010 in Central London.

The Recruiters Annual Forum attracts a senior level audience of recruitment professionals from all industry sectors including those who specialise in recruitment for the pharmaceutical industry.

As an active user of social media to attract and support jobseekers in the pharmaceutical industry, CK Clinical will be speaking about the ways we have built, differentiated and managed our brand on the internet. Further topics will include:

  • Our move away from traditional methods towards a more transparent, web-based recruitment.
  • The social media sites at which should recruitment agencies invest their time: LinkedIn, Facebook, Twitter, Xing and Ning.
  • How does CK Clinical achieve brand differentiation online?
  • Managing user generated content and protecting our brand’s reputation.
  • How will companies be using social media in 12 months time?

To keep up to date with all the key issues that will be addressed at the Recruiter Annual Conference you can join their Linkedin Group here.

 

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry. 

CKC01linkedinckclinicalfacebookckclinical twitterckclinicalyoutube

Posted in company news, NewsTagged in , , , , , , , , , , , ,