Regulatory Documentation Scientist Job in Hertfordshire UK

CK Clinical is currently looking for a Regulatory Documentation Scientist to join a global pharmaceutical company based in Hertfordshire, UK.

Regulatory Documentation Scientist Job Description

As Regulatory Documentation Scientist, you will be responsible for the preparation of regulatory documents for submission to regulatory authorities within subject area (clinical/safety). This role involves working in close partnership with the medical/scientific content owners in the relevant functions. Previous experienced in preparing Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) is desired.

Key responsibilities of this Regulatory Documentation Scientist role will include:

– Using your talent for consistent and accurate scientific writing you will manage the preparation of Development Safety Update Reports (DSURs) – Also responsible for preparing Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs), ensuring that they are of the highest possible quality and in line with internal/external guidelines and requirements – As a key member of Safety Team you will gain a good understanding of any drug safety issues – Work closely with the Safety Science Leader to ensure that issues are effectively communicated in documents you prepare – You will also have the opportunity to work with colleagues from a range of other disciplines across the globe, including, clinical development, clinical operations, marketing and regulatory, in order to gather the safety and other content of your documents – In this role you will also have the opportunity to contribute to best practices & continuous improvement within Regulatory Documentation – Liaising with contributors, analysing and interpreting data, creating production timelines and managing the review and publication process, you will apply your project management skills to ensure that documents are delivered on time and in accordance with best practice. As a Regulatory Documentation Scientist, you will also provide leadership for a writing team responsible for the preparation of a suite of safety documents, ensuring sufficient allocation of resources along including outsourcing where required

Qualifications, skills and experience:

As Regulatory Documentation Scientist, you will have the following qualifications, skills and experience: – PhD, MSc or equivalent in relevant scientific discipline, or healthcare professional – Post doctoral or previous pharmaceutical experience would be an advantage – Competence in the preparation of a variety of regulatory documents – Strong communication and organizational skills – Strong interpersonal skills – Excellent knowledge of regulatory documentation guidelines pertinent to subject area i.e. Clinical/Safety

How to apply:

Hendre Moolman - Senior Consultant at CK Clinical

Contact Hendre for more details.

Click here to apply online now. For more information, please contact Hendre Moolman at CK Clinical on +44 (0)1438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL24229 in all correspondence.

Looking for a job in Regulatory Affairs?

Click here to search our current Regulatory Affairs jobs now.

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

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.

Looking for a Medical Liaison job?

Click here to register your CV with us today.

Once your CV has been registered with us, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant Medical Liaison jobs we are handling at the moment.

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

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

Not quite what you are looking for? Click here to see our latest clinical jobs

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

Hub Labelling Manager – Surrey

Shreeya Patel at CK Clinical is recruiting for a Hub Labelling Manager to join a global pharmaceutical company at their Surrey site on a 12 month contract.

Responsibilities:

The Hub Labelling Manager is responsible for executing the content management of local product documents regardless of registration procedure. As Hub Labelling Manager you will keep up to date with regional labelling regulations. The role will also oversee content across all labels for their assigned products in their assigned regions and be consistent wherever possible.

As Hub Labelling Manager you will be reporting into the locally based Regional Labelling Team Leader. The Hub Labelling Manager will be expected to utilize regulatory expertise to review, develop and deliver core labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.

Qualifications and skills:

As Hub Labelling Manager you must be able to demonstrate the ability to interpret and apply regional/local regulatory guidance around labelling and associated supportive documentation, both pre and post approval. You must also have a proven strength in logical, analytical and writing ability with complete fluency in the English language.

How to apply:

Apply online:

For more information or to apply for this Hub Labelling Manager position please contact Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk.  Please quote reference number CL24249 in all correspondence.

Click here to see our latest Regulatory Affairs roles

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

PV, Drug Safety, Med Info & Affairs jobs

Please see below for a list of our current Pharmacovigilance, Drug Safety, Medical Information and Medical Writing jobs in the UK.

To find out more and apply, please click on the links below.

Drug Safety Associate – Cambridgeshire, UK

Senior Drug Safety Associate – Cambridgeshire, UK

Drug Safety Specialist – Cambridgeshire, UK

Senior Medical Information Officer – Buckinghamshire, UK

Medical Writing Manager – Slough, UK

Scientific Affairs Manager – Oxfordshire, UK

Medical Liaison Manager – Field-based

Senior Pharmacovigilance Executive – Buckinghamshire, UK

Medical Affairs Manager – Surrey, UK

Regulatory Documentation Scientist – Hertfordshire, UK

Medical Liaison Executive – Ireland

Not quite what you’re looking for?

Click here to search our pharmaceutical jobs now.

Register your CV

Click here to register your CV with CK Clinical.

Once registered one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs you may be interested in.

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

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.

Are you looking for a pharmaceutical role in the UK and Europe? Click here to see our latest pharmaceutical jobs in the UK and Europe

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

Scientific Affairs Manager – Oxfordshire

Hendre Moolman at CK Clinical is recruiting for a Scientific Affairs Manager to join a Pharmaceutical company in an office based role in Hertfordshire.

The Job:

As a Scientific Affairs Manager you will be creating and sustaining the connections with the Scientific Community regarding the company’s Diabetes Care product lines. You will also develop and advance advocacy amongst targeted key opinion leaders. Experience in a similar role and in diabetes is essential.

Responsibilities:

The key responsibilities of this Scientific Affairs Manager role are:

  • Assist with clinical support, they will train health care professionals (physicians) and support clinical operations in medical education
  • Communicate situations and opportunities to the technical, clinical and management teams
  • Participate on Core Teams, providing clinical insight for product development and use
  • Assist Clinical Affairs with development of protocols, Case Report Forms and training materials
  • Develop and maintain professional relationships with KOLs and academic centres that are of commercial and research relevance
  • Present scientific, clinical and educational materials to KOLs, academic centres, and professional diabetes organisations to gain awareness, acceptance, and advocacy of company Diabetes Care products
  • Drive publications and presentations of products based on data and materials collected from KOLs
  • Provide clinical and product training to KOLs and academic centres
  • Implement and support training programs, coordinate activities, information, and resources with other personnel
  • Train healthcare professionals and physicians on products
  • Act as resource for information, ideas and recommendations to R&D and other departments to monitor reactions related to Diabetes Care products
  • Assist with medical content review and professional communication materials and key advocacy initiatives
  • Coordinate and execute regional education and scientific symposia
  • Attend key regional and national scientific and medical meetings

Qualifications and experience;

The successful candidate for this Scientific Affairs Manager will have the experience in one or more of the following areas:

  • Diabetes Clinical Patient Care
  • Diabetes Education
  • Clinical Research and statistical data analysis
  • Health Care management
  • Medical Device industry
  • Scientific and Medical Publications
  • Bachelor’s Degree in a scientific/medical field, Master of Science preferred

Benefits:

Successful candidates for this Scientific Affairs Manager role will enjoy the benefits of working with a global Pharmaceutical company, including a competitive salary, holidays and career progression.

How to apply:

Apply online now

For more information or to apply for this Scientific Affairs Manager role please contact Hendre Moolman on 01438 743 047 or email hmoolman@ckclinical.co.uk Please quote reference CL24122 in all correspondence.

Click here to search our current pharmaceutical jobs online now.

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

Medical Liaison Manager – Field Based

Hendre Moolman at CK Clinical is recruiting for a Medical Liaison Manager to join a Pharmaceutical company in a field-based role that will cover territory in the South West and South Wales

The job:

As a Medical Liaison Manager you will be responding to requests from healthcare professionals for medical/scientific information that will help them to effectively treat their patients with the company products. Experience in Cardiovascular/Neurology/Rheumatology therapy area is preferred. Previous experience in a similar vacancy is required. Territory to be covered will be South West and South Wales.

Key responsibilities:

 The main responsibilities as a Medical Liaison Manager will be:

  • Reporting to the Regional Business Leader you will be part of a Regional field based leadership team, responding to requests from healthcare professionals for medical/scientific information that will help them to effectively treat their patients with the company products
  • The information provided maybe within the terms of the marketing authorisation or within the category of legitimate exchange of information during the development of a new medicine
  • You will manage the important liaison between the HCP and the relevant internal functions at the company, exploring and identifying opportunities for building partnerships that benefits both parties
  • Being field based you will be providing first line medical support to the local sales team, helping them understand the medical needs of local customers, whilst adhering to the ABPI Code of Practice
  • Naturally, you will ensure that all of your work complies with the company’s and other regulatory and industry procedures and standards, including the ABPI code of practice

Qualifications and skills required:

To be successful in this Medical Liaison Manager role you will have a life sciences degree and/or proven experience of working in a clinical or scientific role within the pharmaceutical industry or the NHS. You will also have a sound understanding of the NHS and the ABPI Code of Practice.

  • You will be skilled at understanding, analysing and interpreting data from clinical trials. Your knack for conveying complex concepts concisely combined with your excellent presentation skills will enable you to translate and communicate that data
  • Your positive and proactive approach combined with excellent communication, inter-personal and influencing skills will enable you to build and sustain partnerships in your locality
  • Planning and project management skills, combined with time management skills, will allow you to optimise and prioritise activities in order to deliver the most efficient service to your healthcare professionals
  • The insight gained by your interactions with healthcare professionals will allow you to proactively contribute to strategic discussions to improve the quality and relevance of the research and data generated by the Company

You will also have:

  • Previous Medical Information Experience
  • Good written and verbal communication
  • Ability to prioritise workloads and to negotiate and meet deadlines
  • Customer focused
  • Team player
  • Flexible approach
  • Sound understanding of ABPI Code of Practice and NHS

Benefits:

Successful candidates for this Medical Liaison Manager role will enjoy the benefits of working with a global Pharmaceutical company, including a competitive salary, holidays, and career progression. This is a great opportunity for you to combine your scientific background, clinical expertise with your flair for communication and relationship building

How to apply:

Apply online now

For more information or to apply for this Medical Liaison Manager please contact Hendre Moolman on 01438 743 047 or email hmoolman@ckclinical.co.uk. Please quote reference CL24129 in all correspondence.

Are you looking for a pharmaceutical role in the UK and Europe? Click here to see our latest pharmaceutical jobs in the UK and Europe

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

Clinical Data Scientist – South East

Priya Mukherjee at CK Clinical is currently recruiting for a Project Data Manager to work for a global Pharmaceutical company in the South-East.

Responsibilities:

The main responsibilities for this Project Data Manager/ Clinical Data Scientist role will include:

  • Work with Study Team members to assist in management of overall study data quality and integrity.
  • Responsible for coordination of data processing work done at offshore.
  • Perform eCRF data validation to ensure data integrity and quality including raising and resolving data queries.
  • Load, validate and reconcile vendor data including scans and biomarker data.
  • Work closely with colleagues and senior staff to assure consistency and accuracy of the database.
  • Effectively communicate with colleagues and customers to maintain a consistent approach to work.

Qualifications and skills:

Interested applicants for this Project Data Manager/ Clinical Data Scientist role will have a BSc (OR Equivalent) in a Life Sciences discipline together with:

  • Effective project/time management skills
  • Effective communication skills
  • Experience of working in EDC systems, ideally InForm
  • Experience of working in multi-disciplinary teams
  • Sound knowledge of data management processes
  • Sound knowledge of clinical development process
  • Experience of managing external/non CRF data from External vendors
  • Flexibility, a positive and pro-active attitude and excellent team player skills are all essential.
  • Oncology data management, local and central lab validation experience is also preferred.

How to apply:

Apply online now

For more information or to apply for this Project Data Manager/ Clinical Data Scientist role please contact Priya Mukherjee at CK Clinical on 01438 743 047 or email pmukherjee@ckclinical.co.uk. Please quote reference CL24166 in all correspondence.

Click here to see our latest data management jobs!

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

Pharmaceutical Jobs in this Week – 19.4.2012

Here is a list of the latest pharmaceutical jobs that the Consultants here at CK Clinical have had in this week.

To find out more or apply, please click on the links below:

Global Clinical Study Design Manager –– Oxon

Clinical Study Manager – Oxon

Clinical Manager, Global Services – Germany

Clinical Manager – Home Counties

Medical Writing Manager – Slough

Senior Medical Information Officer – Buckinghamshire

Scientific Affairs Manager – Oxfordshire

Medical Liaison Manager – Field-based

PV Physician – London

Clinical Assessment Team Leader – South East, UK

Clinical Project Physician –Buckinghamshire

Interim Med Affairs Advisor – Cambridge

 

 

Register your CV

Click here to register your CV with CK Clinical.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to confidentially discuss your requirements and any relevant pharmaceutical jobs we are recruiting for.

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