Mylene Paumier at CK Clinical is recruiting for two Medical Information Associates to join a global pharmaceutical company at their site based in Surrey on a 7 months contract basis.
As Medical Information Associate the main purpose of your role will be to:
Provide technical and medical information with high quality customer service
Research and prepare responses for escalated medical inquiries as well as Scientific Response Documents related to one or two therapeutic areas
Further responsibilities of this Medical Information Associate position will include:
Researching and responding to inquiries received via phone, email, internet or mail
Document the inquiry and response accurately and completely according to relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
Identifying and recording, adverse events and product quality complaints as well as processing fulfilment
Exhibiting broad knowledge of assigned therapeutic area and a solid understanding of pertinent disease state(s)
Handling escalated MI inquiries from various sources
Creating and maintaining MI documents by ensuring that responses are medically and scientifically accurate, timely, balanced, and meet customers’ needs
Ensuring the alignment of response documents to global/regional/local labelling and licensing for all the Countries we support.
Maintains compliance with corporate and departmental training, SOPs and WIs.
As Medical Information Associate, you will have the following qualifications, skills and experience:
Bachelor’s degree in a science/health-related field (Pharmacy Degree Preferred)
Some Pharmacy/Hospital experience preferred
Medical Information/Pharmaceutical experience preferred
High level of Proficiency in both written and spoken English and one or more of the following languages: Norwegian, Danish, Finnish, Swedish, German or French
Proficiency with computer and software applications (Microsoft Office)
This position may required to work occasionally during bank holidays and to work hours outside of the normal local working hours.
For more information regarding this Medical Information Associate job, please contact Mylene Paumier on 01438 743047 or email: mpaumier@ckclinical.co.uk.
As reported by Reuters, according to data from a late-stage clinical trial, Roche’s melanoma drug has been shown to increase the lives of patients by more than a year.
The oral drug, Zelboraf is a targeted and personalised treatment for those skin cancer patients who have a mutation of a gene known as BRAF (this accounts for approximately half of all melanoma patients, which is the deadliest form of skin cancer).
Results from the clinical trials indicated that those patients taking Zelboraf, survived for an average of 13.2 months, compared to 9.6 months for those patients who received dacarbazine chemotherapy. This translates into a 38 per cent reduction in the risk of death from the disease.
Speaking of the new melanoma drug, Jennifer Low, Group Medical Director in Product Development for Roche’s Genentech unit, stated, “The life expectancy for these patients isn’t very long, so they have an opportunity to have therapy that on average improves survival by a really significant amount, and then of course there are also people who do (even) better.”
Are you looking for a new job in the Pharmaceutical Industry?
Priya Mukherjee at CK Clinical is recruiting for a Director of Clinical Data Management to join a leading Pharmaceutical organisation based in South East, UK.
Director of Clinical Data Management Job Description
The purpose of the role is to collaboratively produce and support critical data-based evidence for assertions and label claims about medicines through all Phases (I-IV, NIS, IIT) covering biomarkers, efficacy, safety, PRO/QOL and HEOR HEOR for simple and complicated trial designs and challenging analyses.
As Director of Clinical Data Management, you will handle the day-to-day operational managerial role of single EU Data Management team integrated over UK and Germany delivering a regional tactical focus with strong global liaison on a coordinated joint delivery with other regions – across various therapeutic areas including oncology, cardiovascular, and metabolic. Through strategic leadership in project teams, you will add value to the company by accelerating worldwide product approvals and enhancing EU product market share and appeal. As Director of Clinical Data Management, you will also enhance functional technical expertise in designing, driving and delivering high quality objective core contributions at the heart of the EU drug development and commercialisation process together with the required ‘state-of-the-art’ regional and global infrastructure.
Key Responsibilities:
As Director of Clinical Data Management, you will have the following key responsibilities:
Leads a regional Data Management group who oversees all project related data management activities, including but not limited to developing, directing, prioritizing and monitoring CRF design, data collection, edit checks, consistency of data collection, query management, data quality control, medical coding, SAE reconciliation between clinical trial and drug safety databases, quality audits and evaluations of databases, data review, database locks, and archival of Data Management deliverables and documents. Oversees and monitors project timelines to ensure that established corporate target dates are met.
Encourages, monitors, and facilitates data management activities and interactions between international sites, towards the development and implementation of global data management and standards. You will also Identify and implement best practices to increase efficiency, quality, and timeliness of data management processes and deliverables. You will establish and generate metric reports for monitoring the progress and performance of projects and processes against internal targets and timelines, and establish the target competency requirements for Data Management staff, for both internal and external sources; together with defining the training plan to achieve those targets.
Provide expertise to all areas of data management including project teams, functional areas, and management. You will also monitor data management activities to gauge compliance with standard processes, evaluate contracted CROs and external vendors on an ongoing basis for adherence to contract specifications and expectations.
Evaluate CRO and external vendor candidates as to their ability to perform in accordance to company procedures and quality standards prior to contract finalization. Ensures that the complete archiving of databases, Data Management documents, and records is maintained in accordance with applicable company and regulatory guidelines.
Provides leadership to Data Management in setting short-term and long-term departmental, project, and professional goals and objectives. Create momentum, energy, and opportunities for visibility of group within corporate and functional settings. Expand support to new areas and build new cross-functional relationships while solidifying and enhancing existing relationships.
Qualifications, skills and experience:
The successful candidate for this Director of Clinical Data Management position, you will have the following qualifications, skills and experience:
MS; BS/RN in life sciences (OR Equivalent)
Proven pharmaceutical experience, including data management, clinical trials, and drug development; Proven supervisory/management experience and project management experience, with exposure to vendor risk and performance management, compliance and oversight.
Good oral and written communication skills.
Proficient in Microsoft Office Suite including Word, Excel, and Project
Demonstrated problem solving, analytical, organization, and time management skills
Excellent managerial skills; coaches, guides, and professionally develops direct reports
Exhibits customer focus, flexibility and team spirit
Ability to lead and influence others
Demonstrated experience in leading remote teams
Ability to function effectively in different cultural settings
Proven experience in the implementation of electronic data capture (EDC)
For more information regarding this Director of Clinical Data Management position, please contact Priya Mukherjee at CK Clinical on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk. Please quote reference CL24295 in all correspondence.
Meet Moin Din, Senior Recruitment Consultant at CK Clinical. Moin specialises in recruiting for Medics and senior level appointments within the Pharmaceutical, CRO, Biotechnology and Healthcare industries.
Moin covers all permanent, interim and contract recruitment within CK Clinical’s Medic Recruitment function. To find out more, please watch Moin’s short video below:
Looking for a Medic job in the Pharmaceutical Industry?
As reported by Pharmiweb, GSK announced today that they have increased their shares in Theravance, who they have a long standing partnership with.
Theravance’s shareholders have approved the transaction which will see the UK drug major buy 10 million shares priced at $21.29 apiece. This means GSK now owns about 25.8 million shares in Theravance’s.
The companies have been partners for nearly ten years and have developed Relovair, which combines a once-daily inhaled corticosteroid (fluticasone) with a long-acting beta-agonist (vilanterol). Phase III development has been completed and GSK intends to submit regulatory applications for chronic obstructive pulmonary disease in the USA and Europe in mid-2012.
Priya Mukherjee at CK Clinical is currently recruiting for a Director, Biostatistics to join a leading pharmaceutical organisation at their site in the South East.
The Job:
The purpose of this Director,Biostatistics role is to collaboratively produce and support critical data-based evidence for assertions and label claims about medicines through all Phases (I-IV, NIS, IIT) covering biomarkers, efficacy, safety, PRO/QOL and HEOR HEOR for simple and complicated trial designs and challenging analyses.
Responsibilities:
As a Director, Biostatistics you will
Handle the day-to-day operational managerial role of single EU Biostatistics team integrated over UK and Germany delivering a regional tactical focus with strong global liaison on a coordinated joint delivery with other regions – across various therapeutic areas including oncology, cardiovascular and metabolic.
Through strategic leadership in project teams, you will add value to the company by accelerating worldwide product approvals and enhancing EU product market share and appeal.
Enhance functional technical expertise in designing, driving and delivering high quality objective core contributions at the heart of the EU drug development and commercialisation process together with the required ‘state-of-the-art’ regional and global infrastructure.
Lead a regional Biostatistics group who oversees all project related biostatistical activities.
Develop, directs, prioritises and monitors all statistical programs and processes relevant to clinical trial design, data collection and input, data analysis, data display, QC, and reporting of results with the primary purpose of accelerating worldwide product submissions and investigational product approvals.
Oversees and monitors project timelines to ensure established corporate target dates are met.
Encourage, monitor, and facilitate biostatistical activities and interactions between international sites, towards the development and implementation of global statistical analysis and reporting standards.
Review of all clinical trial protocols, clinical trial reports, and analysis deliverables
Ensure quality of all deliverables related to data analysis, display, and reporting of clinical trial results.
Provide close interaction with cross-functional groups in the review and selection of CROs; develops and reviews CRO contracts; tracks CRO milestone, timelines, and issues; resolves same.
Develop long-range plans for the future of Biostatistics, and monitors metrics and evaluates staff performance. Manages and develops the technical competence and careers of the biostatistical staff.
Provide leadership to Biostatistics in setting short-term and long-term departmental, project, and professional goals and objectives.
Create momentum, energy, and opportunities for visibility of group within corporate and functional settings.
Expand support to new areas and builds new cross-functional relationships while solidifying and enhancing existing relationships.
Qualifications and skills:
The successful application for this Director – Biostatistics job will have the following skills and qualifications:
A Ph.D in Statistics, Biostatistics or Mathematics (OR Equivalent).
Proven Pharmaceutical Industry experience, together with proven supervisory/management and project management experience.
Exposure to vendor risk and performance management, compliance and oversight.
Good oral and written communication skills.
Proficient in Microsoft Office Suite including Word, Excel, and Project
Demonstrated problem solving, analytical, organization, and time management skills
Excellent managerial skills; coaches, guides, and professionally develops direct reports
Exhibits customer focus, flexibility and team spirit
Ability to lead and influence others
Demonstrated experience in leading remote teams
Ability to function effectively in different cultural settings
Proven experience in the implementation of electronic data capture (EDC)
For more information or to apply for this Director – Biostatistics role please contact Priya Mukherjee on 01438 743 047 or email pmukherjee@ckclinical.co.uk. Please quote reference CL24311 in all correspondence.
Once your CV has been registered with us, one of our specialist Recruitment Consultants will be in contact to discuss your requirements and any relevant jobs we are handling at the moment.
As reported by the BBC, Janssen Cilag’s drug for advanced prostate cancer has been approved for use by the National Health Service (NHS).
Janssen Cilag is one of the world’s leading research-based pharmaceutical companies, and the prostate cancer drug that they manufacture, Abirateron has been shown to extend the lives of late-stage prostate cancer sufferers by more than three months.
Developed by the Institute of Cancer Research, the prostate cancer drug took two decades to develop, as Professor Alan Ashworth explains, ”This drug was discovered at the Institute of Cancer Research and is the result of more than two decades of dedicated work by our scientists and collaborators.
“In clinical trials of men with advanced prostate cancer who have already tried chemotherapy, it has been shown to extend life by an average of four months and improve quality of life.”
Fierce Pharma Manufacturing reported that Pfizer may be planning a $129 million expansion at its manufacturing campus in Puurs, Belgium, which is to be announced next week.
Paul Schoeters of the Christian trade union ACV said that plans for a new manufacturing plant and packaging line have been submitted to the works council. He says about 100 new jobs are anticipated to be created due to the expansion.
The union rep also said “This is a crucial investment if one considers the economic climate. It indicates America’s confidence in Puurs and serves as a tremendous boost for employees here,’
Shreeya Patel at CK Clinical is currently recruiting for a Senior Regulatory Affairs Officer to join a pharmaceutical company at its site in Yorkshire
Responsibilities:
As a Senior Regulatory Affairs Officer you will report to the Principal Regulatory Affairs Officer ans have the following responsibilities:
Collate documents and prepare marketing authorisation applications.
Prepare packaging in line with EU regulatory guidelines, submissions to external databases and liaising with user test teams.
Preparation of type I and II variations.
Assessment of PSUR data.
Licence preparation, national, MRP and DCP.
Prepare, review and submit CTAs.
Qualifications and skills:
The successful candidate for this Senior Regulatory Affairs Officer must have the following skills:
Prior experience within regulatory affairs required.
Knowledge of CTAs and MAAs.
Ability to prioritise workload.
Problem solving ability.
Attention to detail.
Benefits:
This Senior Regulatory Affairs Officer role will include the following benefits:
Bonus scheme
Incentive scheme
Discounted gym
How to apply:
For more information or to apply for this Senior Regulatory Affairs Officer role, please contact Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk. Please quote reference CL24273 in all correspondence.
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Associate Director of Regulatory Affairs – London, UK
