Director of Clinical Data Management Job in South East, UK

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)
Priya Mukherjee - Clinical Data Management Recruitment at CK Clinical

Please contact Priya for more details.

How to apply:

Click here to apply online now.

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.

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Meet Moin Din – Medics Recruitment at CK Clinical

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?

Click here to search our current medic jobs online now.

Alternatively, please call us on +44 (0)1438 743 047 or email info@ckclinical.co.uk.

Click here to meet the rest of the CK Clinical recruitment team.

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Director, Biostatistics – South East

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)

How to apply:Priya Mukherjee - Senior Consultant at CK Clinical

Apply online:

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.

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Senior Regulatory Affairs Officer – Yorkshire

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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Data Manager – Paris

Mylene Paumier at CK Clinical is recruiting for a Data Manager to join a global pharmaceutical company at their site based in Paris on a permanent basis.

Responsibilities:

As Data Manager the main purpose of your role will be to:

  • Provide timely and professional ongoing management of project & clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines
  • Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s)
  • Ensure consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects
  • Have business understanding of the compound profile (CDP/TPP) to identify and assist in successful application of data management processes
  • Respond to Health Authority requests for data management issues
  • Support and assist Assistant Data Managers and other Data Managers for allocated trials within assigned project(s)
  • Provide input, review, and maintenance of global working practices and standards
  • Contribute to the development of the Data Management organization through his/her leadership role within the DM Group
  • Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases
  • Ensure appropriate company tracking systems are up to date and accurate
  • Lead and support clinical & non-clinical special projects
  • May deputize for Data Management Group Head and assist in coaching, training and mentoring of Data Management staff.

Qualifications and skills:

As Data Manager, you will have the following qualifications, skills and experience:

  • University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
  • Languages: Fluent English (oral and written) and French
  • Ideally 5 or more years experience in drug development, with at least 4 years in Data Management activities
  • Project team leadership experience required
  • Good technical and problem solving skills
  • Thorough understanding of clinical trial methodology, GCP and medical terminology
  • Ability to work independently, under pressure, demonstrating initiative and flexibility
  • Attention to detail and quality focused
  • Good organizational, planning and project management skills
  • Good interpersonal and communication skills and ability to operate effectively in an international environment
  • Good negotiation skills
  • Thorough understanding of physiology, pharmacology, clinical study objectives and the drug development process
  • Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.

How to apply:

Apply online:

For more information or to apply for this Data Manager position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk. Please quote reference CL24263 in all correspondence.

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Senior Clinical Study Manager Job in London, UK

Russell Oakley at CK Clinical is currently recruiting for a Senior Clinical Study Manager to join a global pharmaceutical manufacturer based in London, UK on a permanent basis.

The company:

This client is a global pharmaceutical manufacturer involved in the development of pharmaceuticals in the therapeutic areas of oncology, diabetes, cardiovascular and hypertension.

Senior Clinical Study Manager Job Description:

As Senior Clinical Study Manager, you will be responsible for  the execution of Phase II and Phase III oncology studies according to ICH guidelines in support of the clinical strategies defined in the Integrated Development Plan (IDP) as they relate to European specific responsibilities. Support of Phase I trials may also be required.

You will be a key member of the oncology clinical team responsible for conducting clinical studies, which includes participating in writing of study protocols; total management of assigned study conduct, including oversight of the study team and CROs/other vendors; identifying and resolving study site issues; managing the study budget and study closeout with a focus on European activities

As Senior Clinical Study Manager, you may also be required to participate in the training of more junior members of staff.

The role will be based in central London but will involve international travel as well as work centred in the UK.

Qualifications, Skills and Experience:

The ideal candidate for this Senior Clinical Study Manager, you will have the following qualifications, skills and experience:

  • Bachelors Degree preferably in Life Sciences, or R.N., or international equivalent.
  • Demonstrable clinical trial management experience including accumulation of one year of monitoring experience required.
  • Demonstrated ability to manage multiple clinical trials on time and within budget.
  • Superior communication skills: written, oral, interpersonal and presentation.
  • Excellent problem solving and analytical skills.
  • Must work effectively in a cross-cultural matrix team environment and be flexible to contribute to the needs of the group.
  • Clear, direct, tactful communication skills are required.
  • Good writing skills with experience in writing study protocols, summaries, clinical brochures, FDA annual reports and other clinical documents for submission to the FDA. Writing should be clear, concise and accurately represent findings.
  • Strategic thinking – Begin to participate in strategic planning. Able to anticipate potential problems and obstacles and plan accordingly.
  • Ability to organize and manage a CRO and multiple sites participating in a clinical trial.
  • Ability to prioritize work effectively to meet timelines.
  • Demonstrates professional and effective presentation skills.
  • Analytical skills – ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
  • Responsible for resolving issues with study conduct with appropriate staff, CRO and study sites for a clinical study.
  • Solid judgment is required before applying the solutions program wide.
  • Good judgment, professionalism and independence are needed in interfacing with staff, CROs, study coordinators, and investigators Interpersonal Flexibility – ability to adapt to other personalities and cultural differences, in a respectful manner that is conducive to goal achievement
  • Resource Management – ability to manage internal and external vendor resources related to study trial conduct.

The following skills are not essential but would be desirable for this Senior Clinical Study Manager position:

  • In depth knowledge of oncology clinical trials.
  • Familiarity with MS Outlook, Word, Excel, etc.
  • Participation in NDA/CTD process

How to apply:

Russell Oakley - Senior Consultant at CK Clinical
Please contact Russell for more details.

Click here to apply online now.

For more information regarding this Senior Clinical Study Manager job in London, please contact Russell Oakley at CK Clinical on +44 (0) 114 283 9956 or email roakley@ckscience.co.uk. Please quote reference CL24219 in all correspondence.

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Medical Liaison Executive Contract Job in Ireland

Hendre Moolman at CK Clinical is currently recruiting for a Medical Liaison Executive to join a successful pharmaceutical company based in Ireland on a contract basis.

Medical Liaison Executive Job Description

As Medical Liaison Executive you will play a key role maximising the opportunities for the company through provision of non-promotional medical expertise and support for our external customers, which will be of significant value to our customers and raise the level of their knowledge of their medicines. The territory covered requires you to be based around Dublin.

Key responsibilities of this Medical Liaison Executive position:

– Provide a medical/clinical pharmacist interpretation of current and newly emerging product and therapy area data to external customers to ensure that external customers have information relevant to their needs

– Provide medical/clinical support to Scientific Affairs and the extended brand team and provide specialist training and therapy area advice to internal teams

– Manage key medical projects to ensure efficient interaction with customers and key customer networks through optimal contact

– Interact with community groups and patient organisations and work with key professional bodies effectively to ensure accurate and fair coverage of product and clinical trial related articles in publications and manage provision of funding within ABPI processes

– Maintain high level specialist technical knowledge in the therapy area

– Demonstrate detailed understanding of ABPI Code of Practice, particularly with respect to promotional versus non-promotional activities

– Understanding new data from research conducted by the company, interpreting this data and delivering it in an appropriate form to both internal and external audiences and support education programmes that are appropriate to their therapeutic area

– Have detailed knowledge of a wide variety of information available to support their own activities, and also provide customers with the output from these resources as appropriate

– Understand the data gathered from medical information sources and how to use tools for gathering medical information

– Understand study methodology and analysis techniques

– Ability to evaluate literature pertaining to the appropriate therapeutic area

– Keep up-to-date with latest developments in the marketplace and the impact these could have on customers

– Participate in the development of the UK marketing strategy

– Prioritises and plans own visits to support UK medical affairs strategic plan

– Work with Medical, Pharmaceutical & Scientific Advisers and sales/marketing teams to ensure best use of skills and expertise in customer contacts

– Plan and lead key medical education activities, successfully incorporate these into brand plans and secure buy in and funding for medical initiatives from the brand team

– Decide and manage provision of funding to community groups and patient organisations according to company processes.

As Medical Liaison Executive you will have the following qualifications, skills and experience:

– PhD in Clinical Pharmacology or related area, or

– UK Registered Pharmacist with clinical experience and experience as Medicines Information pharmacist or

– UK Registered Physician eligible for entry to Higher Medical Training, Specialist nurse or

– Relevant therapy area expertise within NHS and/or Industry

– Demonstrated competencies in analysis and provision of medical/scientific information

– Good numeric and literacy skills; computer literate

– Excellent presentation skills

– Good communication and interpersonal skills

How to apply:

Contact Hendre to find out more.

Click here to apply.

For more information regarding this Medical Liaison Executive position, please contact Hendre Moolman at CK Clinical on +44 (0) 1438  870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL24232 in all correspondence.

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Medical Information Associate – Surrey

Mylene Paumier at CK Clinical is recruiting for a Medical Information Associate to join a global pharmaceutical company at their site based in Surrey on a 7 months contract basis.

Responsibilities:

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
  • 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.
  • Maintain compliance with corporate and departmental training, SOPs and WIs.

Qualifications and skills:

The successful candidate for this Medical Information Associate 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 require the position holder  to work occasional bank holidays and to work hours outside of the normal local working hours.

How to apply:

Apply online:

For more information or to apply for this Medical Information Associate position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk.  Please quote reference CL24240 in all correspondence

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NNovartis buys Fougera Pharmas for $1.525 Billion

Novartis has agreed to buy specialty dermatology generics company Fougera Pharmaceuticals for USD 1.525 billion.

Fougera is a specialty dermatology business with 2011 net sales of USD 429 million, and employs 700 people across its two primary sites, located in New York

The agreement will create a strong global growth platform for Sandoz, which is the pharmaceuticals division of Novartis. Sandoz will use its leading position both in the US generics sector and its presence in over 130 countries worldwide to expand Fougera’s existing sales base and bring its broad dermatology portfolio to new markets around the world.

Jeff George, Global Head of Sandoz said “The addition of Fougera’s leading portfolio further strengthens Sandoz’s differentiated products strategy and improves our ability to help patients and customers around the world by providing easier access to high quality, affordable dermatological medicines. Fougera brings us valuable technical capabilities in the area of topical dermatological products, particularly in the development and manufacturing of semi-solid forms such as creams and ointments,”

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Medical Writing Manager – Berkshire

Hendre Moolman at CK Clinical is recruiting for a Medical Writing Manager to join an established pharmaceutical company based in Berkshire.

The Job:

This Medical Writing Manager role offers a unique opportunity to have involvement with a broad range of medical writing documents study reports, investigator brochures, module II documents, and documents that take an overview of study documents (not just the compound/CMC).  This position will support global and regional submissions. This is a customer facing role as part of an internal service provision.

Responsibilities:

The key responsibilities for this Medical Writing Manager role are the following:

  • Ensure that all medical writing documents prepared for assigned Clinical Research Programmes within the company’s R&D are prepared according to appropriately rigorous, objective and informative medical writing procedures and processes.
  • Lead the Medical Writing activities for US, European or other regulatory submissions as assigned.
  • Ensure documents for assigned clinical trials are prepared, reviewed, and approved in a quality, timely and accurate manner such that the date presented will withstand examination by regulatory bodies.
  • Support the full use of the Electronic Document Management System (EDMS), for all clinical documents intended for submission, within the company.
  • Plan, schedule and track all assigned medical writing activities in close cooperation with the GPLs to ensure high quality, timely, and accurate completion of all documents at each point in the document lifecycle, and to provide monthly status reports and forecasts to the HMW.
  • Take responsibility for supervision/production, review, publishing, and finalization of assigned study reports.
  • Work with the HMW and MWM (IBs) for strategic planning, production & review of assigned summary documents.
  • Provide disease area guidance to internal and external writers for assigned projects
  • Take responsibility for ensuring that assigned medical writing deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
  • Supervise assigned medical writing projects contracted to third party suppliers, including interim and final integrated study reports and, where appropriate, integrated clinical summaries, protocols or other documents.
  • Take responsibility for ensuring that outsourcing of assigned medical writing projects is conducted after a thorough evaluation of the capabilities of the CRO/freelancer concerned, that the deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
  • Undertake assigned medical writing projects within including interim and final integrated study reports and where appropriate, integrated clinical summaries, protocols or other documents.
  • Ensure that assigned protocols, clinical study reports and investigator brochures and other documents as appropriate, are developed with medical writing input as early as possible.
  • Take responsibility as a medical writing adviser to project teams across assigned disease areas.
  • Work with the publishers to ensure quality, timely and accurate deliverables at each stage of the document lifecycle, to contribute to and to supervise accurate and timely publishing within EDMS.
  • Develop awareness of the benefits of the EDMS in the preparation of clinical documents.
  • Interact with other groups in order to provide an efficient, effective and timely medical writing service. Groups will include Clinical Development Teams, Study Teams and other groups as appropriate.
  • Keep abreast of current issues and developments in medical writing, particularly those impaction the neurology disease area.
  • Perform any other activity as may reasonably be required from time to time.
  • Complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the company.

Benefits:

Successful candidate for this Medical Writing Manager role will enjoy the benefits of working with a global Pharmaceutical company, including a competitive salary.

Qualifications:

The ideal candidate for this Medical Writing Manager role will have the following qualificaitions and

  • Life Science Degree, preferably with a higher degree (MSc or PhD) or other relevant qualifications
  • Good understanding of GCP, coupled with prior experience in clinical/preclinical pharmaceutical research and development.
  • Good understanding of the clinical development process and of ICH guidelines
  • Significant experience of working on summary level documents such as the Common Technical Document or Investigator’s Brochures.

How to apply:

Apply online:

For more information or to apply for this Medical Writing Manager job please contract Hendre Moolman on 01438 743 047 or email hmoolman@ckclinical.co.uk. Please quote reference CL24065 in all correspondence.

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