Pharmaceutical jobs of the week: 18/06/2015

Here are our latest pharmaceutical jobs in this week 18/06/2015:

 

Clinical operations/development jobs:

Clinical Operations Manager -Part Time- Home Based

AD, Project Management -Oxfordshire

Occupational Health Advisor – Field Based

Global Study Manager – Hertfordshire – Office based

Associate Director, Molecular Diagnostics – Cambridgeshire

Research Physician – South/central belt of Scotland

 

Biometrics jobs:

Statistical Programmer – Belgium

 

Clinical supplies jobs:

AD Of Logistics & Customer Support – Middlesex

 

PV & medical information jobs:

Regulatory Documentation Scientist – Hertfordshire

Pharmacovigilance Project Manager – Hertfordshire

Pharmacovigilance Project Manager – Hertfordshire

 

Regulatory affairs jobs: 

Submission Sample Coordinator – Middlesex

Senior Regulatory Manager – Surrey

 

If these jobs are not quite right for you, find out more about this job here.

 

 

 

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Pharmaceutical Jobs of the Week: 25/09/2014

Here are our latest pharmaceutical jobs of the week 25/09/2014:

 

Sales and Marketing Jobs:

Hospital Sales Specialist – Central London

Hospital Sales Specialist – Scotland

Hospital Sales Specialist – North London

 

Finance Jobs:

Financial Analyst EMEA

 

Clinical Operations Jobs:

Clinical Study Manager – Cambridge or Middlesex

Clinical Research Nurse – North West

Associate Director, Clinical Operations – Hertfordshire

 

Market Access/Health Economics Jobs:

Market Access Manager – London

Health Economics Manager – South East

 

Biometrics Jobs:

Principal Biostatistician – Home counties

 

Regulatory Affairs Jobs:

UK Clinical Trial Regulatory Leader – South East

Senior Manager, CMC, GRA – Hertfordshire

 

Med Info Jobs:

Scientific Review & Info Specialist – South East

Medical Customer Interface (MCI) Manager – South East

Senior Pharmacovigilance Scientist – Buckinghamshire

 

If this is not quite what you are looking for, search our other pharmaceutical jobs here

 

 

 

 

 

 

 

 

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Pharmaceutical Jobs of the Week: 18/09/2014

Here are our latest pharmaceutical jobs in this week 18/09/2014:

 

Medical Information/Affairs, Drug Safety and PV Jobs:

Medical Customer Interface (MCI) Manager – South East

Senior Pharmacovigilance Scientist – Buckinghamshire

Medical Affairs Manager – Epilepsy – Hertfordshire

KAM – Thames Valley  – South East

KAM – South East & South Coast

 

Regulatory Affairs Jobs:

Senior Manager, CMC, GRA – Hertfordshire

Regulatory Affairs Manager – Middlesex or Cambridge

Manager/Senior Manager, Reg Affairs, Neuro, GRA – Hertfordshire

 

Clinical Operations/ Physician Jobs:

Associate Director, Clinical Operations – Hertfordshire

Study Site Relations Clinician – Home counties

AD, Clinical Development (Physician) – Cambridgeshire

Feasibility & Patient Recruitment Manager – Middlesex

Regional Medical Monitor – Surrey

 

Biometrics Jobs:

Senior Programmer – Greater London

SAS Programmer – South East

 

If these jobs are not right for you, search our other pharmaceutical jobs here

 

 

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Pharmaceutical Jobs of the Week: 10/02/2014

Here are our latest jobs in this week 10/02/2014:

 

PV & Medical Information:

Senior Compliance Officer – South East

Medical Communication Manager – Contract – Uxbridge

Medical Information Manager Oncology – Contract – South East

Medical Science Liaison – UK (anywhere)

Senior Clinical Drug Safety Scientist – Buckinghamshire

 

Biometrics:

Biostatistician – Belgium

Statistical Programmer – South East

Study Data Manager – South East

Clinical Data Standards Specialist – Belgium

 

Clinical Operations:

Senior Associate, Clinical Operations – South East

Clinical Study Specialist – South East

Associate Director, Study Management – Home counties

 

Regulatory Jobs:

Senior Regulatory Professional – South East

Senior Manager CMC Regulatory Affairs – Hertfordshire

Regulatory Affairs Senior Manager – South East

 

 

 

 

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Clinical Jobs of the Week: 03/02/2014

Here are our latest clinical jobs in this week:

 

Biometrics:

Clinical Data Standards Specialist – Belgium

Biostatistician – Belgium

Statistical Programmer – Belgium

 

PV & Medical Information:

Senior Clinical Drug Safety Scientist – Buckinghamshire

Pharmacovigilance Director – Homecounties

Medical Science Liaison – South West

Risk Manager – EMEA – Hertfordshire

Clinical Safety Scientist – London

 

Clinical operations:

Associate Director, Study Management – Homecounties

Clinical Scientist – Vaccine – South East

 

Regulatory Affairs:

EU Translations Coordinator – South East

Principal Regulatory Officer – Homecounties

Regulatory Senior Medical Writer – South East

Medic:

Medical Director, Safety Evaluation – Homcounties

 

 

 

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Associate Director – Cambridgeshire

Ben Traies is recruiting for a permanent GMC registered Associate Director within Clinical Science with a leading global pharmaceutical development organisation, based at their site in Cambridgeshire.

You will join a clinical development group overseeing a portfolio of products for Autoimmune diseases, including a major Phase III study and a number of assets approaching First in Man trials. This will be a global role in which opportunities for further development will arise as the portfolio matures.

Responsibilities

  • Development and execution of varied clinical development plans
  • Performing medical date review across a number of studies
  • Analysis and review of trial data
  • Preparation of the relevant components of documents such as Investigator Brochures, Ethics Submissions and INDs

Qualifications

  • Very strong experience within clinical development of immunological products
  • GMC registered
  • Proven programme management experience, having progressed products through clinical trial phases
  • Experience of working collaboratively with colleagues in translational science

How to applyBen Traies - Director at CK Clinical

Click here to apply now

For more information or to apply for this role please contact Ben Traies on 01438 842968 or email btraies@ckclinical.co.uk.

Click here to search our other clinical jobs

pharmaceutical jobs     CK Clinical 2013 Salary Survey

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Our Latest Pharmaceutical Jobs – 15th November 2012

Looking for a new job in the Pharmaceutical Industry? Please click on the links below to find out about our latest pharmaceutical jobs new in this week:

Clinical jobsDrug Safety:

Senior Medical Information Officer – Greater London

Clinical Safety QA Manager – South East

Regulatory Affairs:

Regulatory Affairs Associate  – Mauritius

CK Clinical jobsRegulatory Affairs Leader – Mauritius

Operations Specialist I – Kent

Clinical:

Associate Director, Project Planning – London

Human Resources Administrator – Homecounties

Clinical JobsMedic:

Medical Director – Diabetes/Metabolisim – South East

Biometrics:

SAS Programmer – Welwyn Garden City

 

Not quite what you’re looking for? Click here to register your CV with CK Clinical today.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs we are recruiting for at the moment. Good luck with your job hunt.

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Clinical Submissions Writing Manager – Germany

Priya Mukherjee at CK Clinical is currently seeking an Associate Director, Clinical Submissions Writing Manager for a leadin

g pharmaceutical company

in Germany, to work within the Global Medical Writing/Clinical Submissions Writing department.

 Responsibilities:

As a Clinical Submissions Writing Manager you will have the following the responsibilities:

  • To manage up to 6 (senior) Medical Writers. Coach, train and mentor staff, thereby contributing to successful development, registration in key regions and commercialisation of new drugs and biologic agents, including important lifecycle management work (new line extensions, indications and/or formulations of late-stage development or already registered compounds).
  • Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation.
  • Prepare clinical submission documents for a regulatory audience, within a team environment, according to  SOPs.
  • Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner.
  • Provide process, content, and submission/document planning expertise to the Clinical Submission Team, the Clinical Satellite Team, and the Clinical Trial Team.
  • Advise the team on resource utilization, efficiencies, timelines, and interdependencies. Participate in and/or lead the development of processes and tools related to document authoring, management, and quality control in support of the departmental goal to develop best-in-class processes, tools, and standards to foster open communication, quality, efficiency, and cost-effectiveness of clinical document generation to support the delivery of high-quality documents within realistic and ambitious timelines.
  • Share expertise within Medical Writing by coaching/mentoring (Senior) Medical Writers.
  • Act as a Clinical Program Medical Writer.
  • Provide process, content, and planning expertise to the Clinical Trial Team, the Clinical Satellite Team, and the Submission Team regarding document preparation, submission strategy and consistent scientific messaging.
  • Advise the team on Medical Writing resource utilization, efficiencies, timelines, and interdependencies.
  • Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging, and style. Coordinate with other Clinical Program Medical Writers and other Medical Writers as needed to maintain consistency across documents within a project and across indications.
  • Participate in and/or lead the development of processes and tools related to authoring and reviewing of clinical documents.
  • Maintain and demonstrate expert knowledge of drug development process and applicable regulatory guidelines.
  • Liaise with vendors/external contractors as assigned.
  • Ensure timelines and quality of product when the writing of a document is outsourced.

Qualifications and skills:

Interested applicants for this Clinical Submissions Writing Manager role should have the following skills and qualifications:

  • Bachelor’s degree (OR Equivalent)
  • Proven experience in Medical Writing in the Biopharmaceutical industry including regulatory writing experience.
  • Experience in people management and you are also able to coach and/or mentor more junior colleagues.
  • Work methodically and you should have excellent written and verbal communication skills (also in English).
  • The ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.

 

Priya Mukherjee - European Operations Manager at CK Clinical

Please contact Priya for more information.

How to apply:

Apply online:

For more information please contact Priya Mukherjee on +44 (0)207 470 5673 or email pmukherjee@ckclinical.co.uk. Please quote reference CL25358 in all correspondence.

 

Not quite what you’re looking for?

Click here to search our current pharmacovigilance positions online now.

      

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Associate Director Biometrician – Switzerland

Priya Mukherjee at CK Clinical is recruiting for an Associate Director Biometrician required to work for

a leading pharmaceutical organisation in Switzerland.

Responsibilities:

The Associate Director Biometrician is responsible for providing expert statistical analytic solutions across multiple disease areas within a Franchise or equivalent and able to seamlessly move across the portfolio within a Franchise. They are responsible for statistical analytic support to clinical development programs, mentoring other biometricians stretching through to the full spectrum of capabilities

Main Responsibilities:

  • Lead the statistical analytic contributions to the clinical development programs within a Franchise, in collaboration with the Statistical Scientist, comprising all relevant technical and disease area knowledge.
  • Drive in developing statistical strategic quantitative contributions to regulatory/ submission strategy and related documents via expert statistical analytic solutions with excellent interface to the Statistical Scientist: Decision criteria, CSPDs, MAPs, project development strategy and trial designs, responses to HA questions.
  • Be responsible for leading statistical analytic solutions for regulatory submissions and health authority interactions, by working with statistical scientists and programmers.
  • Provide expert statistical analytic support to the Statistical Scientist in developing the pooling strategy specifically for compounds that are developed for multiple indications within a Franchise and develops the detailed statistical methodology for the MAP, CSPDs and attend submission planning meetings.
  • Represent biometrics at the GPT meetings and other internal decisions boards in collaboration with the Statistical Scientist.
  • Provide statistical computational expertise for scenarios simulations to optimize program/trial and analysis strategies through to sample size and probability of success calculations in collaboration with the Statistical Scientists for CDP writing.
  • Provide expertise specifically to high complexity programs to execute the CSPD, advisory committee tables, figures and listings.
  • Ensure high quality for all deliverables and processes.
  • Foster efficient expert interfaces with internal and external customers with support of management.
  • Drive statistical research in collaboration with statistical scientists and the commercial organization by providing expertise and trouble shooting on computational statistical aspects of the problem.
  • Lead the statistical analytic solutions to the exploratory analyses.
  • Define future directions for computational solutions / liaises with programming defining future generic code.
  • Maintain strong and broad based statistical expertise – maintain knowledge of mainstream and newly emerging statistical /numerical techniques / algorithms.
  • Take leadership in influencing internal discussions for white papers for general analytic practice internally and establishing external presence.
  • Drive, steer and mentor others, and may undertake role of development/appraisal coordinator for selected Franchise associates.

Qualifications and skills:

To be considered for this Associate Director Biometrician role the successful candidate will have the following qualifications and experience:

  • Proven in up-to-date statistical knowledge/ applications and expert in analytic aspects. A deep understanding of drug development and HA guidelines.
  • Excellent knowledge of / experience with SAS/ R/ Splus or any other business or research analytic software
  • Establish record in operating at program level
  • Strong interpersonal and communication skills (verbal and written), strong disease area knowledge
  • Strong team skills.
  • Establish track record of trouble shooting skills including significant regulatory/ decision making support
  • Natural modern leadership style building partnerships and collaborative environments.

HPriya Mukherjee - European Operations Managerow to apply:

Apply online:

For more information or to apply for this Associate Director Biometrician role please contact Priya Mukherjee on +44 (0) 2074 705 673 or email pmukherjee@ckclinical.co.uk. Please quote reference CL25348 in all correspondence.

 

Are you looking for a new pharmaceutical job in Europe?

Click here to see our latest jobs in Europe

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