Posts Tagged ‘pharmaceutical jobs’
Monday, April 12th, 2010
Regulatory Publisher based in Hatfield, Hertfordshire, UK.
As Regulatory Publisher you will primarily be responsible for publishing eCTD sequences for centralised, MRP, DCP submissions. Reporting to the Senior Manager of Global Regulatory Operations, you will be expected to self manage each project by working closely with regulatory, clinical and CMC leads wherever necessary. Working as Regulatory Publisher you will also be expected to support major submissions publishing project by assisting in formatting of word documents, bookmarking, hyperlinking and QC when necessary.
Key responsibilities of this Regulatory Publisher role will include:
- Publish eCTD sequences for centralised, MRP and DCP submissions.
- Updates and issues communicated during management meetings.
- Support Major Submissions Publishing projects.
The successful candidate for this Regulatory Publisher job will have previous experience of publishing eCTD sequences. In addition, the following skills and competencies are also essential for this Regulatory Publisher role:
- Excellent verbal and written communication skills.
- Ability to gather necessary information when required for assigned eCTD life cycle projects.
- Ensure lifecycle and publishing projects are processed in accordance with agency guidelines and SOPs.
- Understanding of lifecycle management.
- Ability to present information in a clear and concise manner.
- Knowledge of ICH regulations and guidelines.
How to Apply for this Regulatory Publisher Job:
For more information, or to apply for this Regulatory Publisher job, please contact Meera Pattni on +44 (0)1438 743047 or email mpattni@ckclinical.co.uk/
Alternatively, click here to apply for this Regulatory Publisher job now.
Tags: CK Clinical, ck regulatory, Hatfield, Hertfordshire, Herts, job, Jobs, pharma jobs, Pharmaceutical, pharmaceutical jobs, pharmaceutical recruitment, Reg Affairs, Regulatory Affairs, Regulatory Affairs Jobs, Regulatory Affairs recruitment, Regulatory Publisher, south, South East, uk
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Thursday, March 11th, 2010
Our client, a pioneering biotechnology company, is currently looking for a Regulatory Affairs Manager to join their team based in Uxbridge, UK.
As a Regulatory Affairs Manager, you will be responsible for:
- Using your knowledge of internal regulatory affairs to provide input into product strategy for the IE region.
- Preparing internal market applications for new products.
- Reviewing post market variations.
- Liaise with CMC and help support the execution of labelling variations within the region.
- Keep the IE project lead informed of all developments to do with the life cycle activity.
- Provide advice and support on regional regulatory mechanisms to optimise product registration.
- Contribute to product strategy.
- Track status of MAA, variations, submissions and approvals.
- Lead preparation of responses to questions raised by regulatory authorities.
The ideal candidate for this Regulatory Affairs Manager job will be educated to minimum Bachelors degree or will have equivalent education/experience. A Masters or Doctorial degree would be advantageous.
How to Apply
In order to register your interest in this Regulatory Affairs Manager job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.
Alternatively, click here to apply for this Regulatory Affairs Manager job now: http://ckclinical.co.uk/job/Regulatory-Affairs-Manager/ebb03e1fOVJO
About CK Regulatory
CK Regulatory is a specialist Recruitment company offering job opportunities to Regulatory Affairs professionals seeking work in Pharma, Biotechnology, Medical Devices and Regulatory Consultancies. As part of CK Clinical we have an established and enviable track record of providing a high quality recruitment service to Pharmaceutical professionals.
Tags: based in Uxbridge, Biotechnology, Clinical jobs, clinical recruitment, Data Management jobs, drug safety jobs, job, Jobs, jobs in pharma, Medical information jobs, Medical writing, pharmaceutical jobs, pharmaceutical recruitment, pharmaceutical regulatory affairs, Pharmacovigilance Jobs, Reg Affairs, reg affairs job, Regulatory Affairs, Regulatory Affairs Manager, Regulatory Affairs Manager (Emerging Markets), Regulatory Affairs recruitment, uk, uxbridge
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Tuesday, March 9th, 2010
Our client, a company which specialises in the research and development of prescription drugs, are currently looking for a Senior Regulatory Affairs Executive to be based in Buckinghamshire.
Reporting to the Regulatory Affairs Manager, your main responsibilities as a Senior Regulatory Affairs Executive will include:
- Maintenance of clinical trial and marketing authorisation applications.
- Preparing and submitting applications to the relevant authorities.
- Keep up to date with legislation’s affecting pharmaceuticals in UK and Europe.
- Preparation and maintenance of text for PILs, SPCs and more.
- Take responsibility for ensuring company promotional materials are compliant with legislation’s.
- Keep in contact and maintain a good working relationship with the MHRA and other regulatory authorities
The ideal candidate for this Senior Regulatory Affairs Executive will have the following skills and competencies:
- A good work knowledge of regulatory affairs.
- Excellent written and verbal communication skills.
- Broad experience in the pharmaceutical industry.
- Experience within marketing, research and information functions are beneficial.
How to Apply
If you would like to hear more about this Senior Regulatory Affairs Executive role, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.
Alternatively, click here to apply for this Senior Regulatory Executive job now.
If this vacancy is not exactly what you are looking for why not give us a call, we may be dealing with a vacancy better suited to your needs.
About CK Regulatory
CK Regulatory is a specialist Recruitment company offering job opportunities to Regulatory Affairs professionals seeking work in Pharma, Biotechnology, Medical Devices and Regulatory Consultancies. As part of CK Clinical we have an established and enviable track record of providing a high quality recruitment service to Pharmaceutical professionals.
Tags: Buckinghamshire, bucks, CK Clinical, ck clinical jobs, ck regulatory, Clinical jobs, clinical recruitment, job, Jobs, Medical Information, Pharmaceutical, pharmaceutical jobs, Recruitment, Reg Affairs, Regulatory Affairs, Regulatory Affairs Manager, senior regulatory affairs executive, uk
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Tuesday, February 23rd, 2010
Our client, one of the world’s leading pharmaceutical companies is currently looking for an EU Regulatory Strategist to join their team based in the South of England.
Reporting to the EU Regulatory Strategy Portfolio Manager, your role will include:
- Ensuring EU contribution to Global Regulatory Strategies and implementation plans.
- Ensuring that the regulatory contributions work towards achieving the objectives in the strategy.
- Be responsible for providing the required regulatory contributions to project teams, adhering to time and cost deadlines.
- To liaise with Senior Management regarding regulatory plans.
- Work closely with the Regulatory Product manager to ensure consistent and appropriate process, working practices and quality standards.
The ideal candidate for this EU Regulatory Strategist role will be educated to a minimum degree level in a scientific subject and will have demonstrable have experience of the following:
- EU regulations.
- CTA and MAA submissions process.
- Management of complex regulatory issues.
If you would like to hear more about this EU Regulatory Strategist job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.
Alternatively, click here to apply for this EU Regulatory Strategist job
Click here to apply for other Regulatory Affairs jobs.
About CK Regulatory
CK Regulatory is a specialist Recruitment company offering job opportunities to Regulatory Affairs professionals seeking work in Pharma, Biotechnology, Medical Devices and Regulatory Consultancies. As part of CK Clinical we have an established and enviable track record of providing a high quality recruitment service to Pharmaceutical professionals.
Tags: CK Clinical, ck regulatory, Clinical jobs, clinical recruitment, communication, CTA, EU, EU regulations, EU Regulatory Strategist job, MAA, pharma, pharmaceutical company, pharmaceutical jobs, pharmaceutical recruitment, Reg Affairs, Regulatory Affairs, Regulatory Affairs recruitment, south, South East, strategies, uk
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Wednesday, February 3rd, 2010
Our client is a leading healthcare pharmaceutical company, who specialise in the discovery and development of innovative therapies that contribute to the health and well-being of people the world over. This multinational pharmaceutical organization are currently looking for a Regulatory Submissions Manager to join their Regulatory Affairs team based in the South East of England.
Reporting to the Senior Manager, Global Regulatory Operations, you will be responsible for developing the submission timelines with the team leader and eDocumentatin representative. You will be required to collect status updates from members of other teams and informing the Project manager of these activities. You will also be responsible training new members of staff on the submission process.
Further key tasks involved with this Regulatory Submissions Manager job will include:
- Arranging the submission team meetings.
- Developing agenda items by working alongside the RA team leader.
- Facilitating EU RA meetings to manage eCTD marketed product lifecycle.
- Liaising with other team members regarding strategies and targets.
- Developing the submission timeline.
- Maintaining regulatory submissions calendar.
The successful candidate for this Regulatory Submissions Manager job will have a sound knowledge of regulatory submissions/ePublishing, as well as the ability to ensure that submissions adhere to internal SOPs. Further competencies required for this job include:
- Excellent communication skills to interact with colleagues.
- Good problem solving skills.
- Project management experience.
This is an excellent opportunity for the right candidate to develop their career within Regulatory Affairs within a fast paced and nurturing pharmaceutical company which operates on a global basis.
If you would like to hear more about this Regulatory Submissions Manager job, please contact Meera Pattni on 01438 743037 or email mpattni@ckclinical.co.uk.
Alternatively, apply for this Regulatory Submissions Manager online now.
About CK Regulatory
CK Regulatory is a specialist Recruitment company offering job opportunities to Regulatory Affairs professionals seeking work in Pharma, Biotechnology, Medical Devices and Regulatory Consultancies. As part of CK Clinical we have an established and enviable track record of providing a high quality recruitment service to Pharmaceutical professionals.
Tags: Home Counties, job, Jobs, London, operations, pharmaceutical industry, pharmaceutical jobs, pharmaceutical regulatory affairs, pharmaceutical regulatory systems, Reg Affairs Jobs, Regulatory Affairs, Regulatory Affairs Jobs, Regulatory Submissions, regulatory submissions manager, South East, uk
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Thursday, January 14th, 2010
Project Manager – Health Outcomes Consultancy
- Salary range £35-40K plus bonus and generous pension
- 27 days holiday plus loyalty days
- Central London location
Xcelerate Health Outcomes is a dynamic and fast growing unit of NHS Innovations London offering health economic consultancy to the pharmaceutical and medical devices industry as well as NHS Trusts. The unit helps clients to conduct economic evaluations in medicines and healthcare interventions by carrying out projects which incorporate health economic and patient data. We are now seeking to expand the unit by recruiting an experienced Project Manager. The main purpose of the role is to provide project management expertise for Health Outcomes studies conducted on behalf of pharmaceutical and medical device companies and other healthcare stakeholders.
Key responsibilities
- Project management of Health Outcomes studies commissioned by pharmaceutical and medical device companies
- Production and analysis of project plans, milestones and resource requirements
- Monitoring project progress and providing regular updates and reporting internally and externally to industry clients
- Negotiation and liaison with Hospital Trusts to obtain patient data for projects
- Recruitment of study centres and investigators within the Trusts and communicating study objectives
- Set up all legal and contractual arrangements with investigators, study centres and Trusts
- Coordination and management of data collection within agreed timelines
- Resource and cost management of project
OTHER RESPONSIBILITIES
- Work closely with other members of the Health Economics team to deliver project outputs within agreed timeline
- Identify any risk management issues and conduct contingency planning
- Liaison with other teams within NHSIL and provide project management expertise and input when required
- Work with the wider organisation to facilitate access to investigators and study centres
- Medical/clinical experience and background preferred
The Company is sited at refurbished, air conditioned offices in central London. To apply please visit our web-site at http://www.nhsinnovationslondon.com/about-us/vacancies-and-opportunities/ and e-mail an application form together with a detailed CV.
We are committed to appointing on merit, seeking candidates from a diverse range of backgrounds and taking full account of equal opportunities.
Tags: central london, London, nhs, nhs jobs, pharmaceutical jobs, pharmaceutical recruitment, project manager, project manager jobs, Xcelerate Health Outcomes
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Wednesday, January 13th, 2010
Health Economist- Health Outcomes Consultancy (Full or Part Time)
- Salary range £35-50K plus bonus and generous pension
- 27 days holiday plus additional loyalty days
- Full or part time considered
- Central London location
Xcelerate Health Outcomes is a dynamic and fast growing unit of NHS Innovations London offering health economic consultancy to the pharmaceutical and medical devices industry as well as NHS trusts. The unit helps clients to conduct economic evaluations in medicines and healthcare interventions by providing expertise, advice and unique access to patient data. We are now seeking to expand the unit by recruiting an experienced Health Economist:
The main purpose of the role is to provide health economics expertise to define, plan, research, model, evaluate, analyse and conduct Health Outcome studies for pharmaceutical and medical device companies and where required to help in the economic evaluation of new innovations and changes in healthcare interventions and pathways in NHS Trusts.
KEY RESPONSIBILITIES
- To design and conduct Health Outcomes projects for Pharmaceutical and Medical Device companies based on client requirements
- Apply Health Economic methods including quality of life and cost effective analyses and develop economic models to support Health Outcomes Studies
- Develop statistical analysis plans and undertake statistical analysis of patient data to generate the study output.
- Specifically and when required, develop protocols, undertake literature reviews, develop CRF’s for data capture and generate material for scientific reports and publication
OTHER RESPONSIBILITIES
- Support the business development, consultants and management in capability presentations, company meetings and conferences
- Input Health Economics expertise into project proposals and presentations
- Evaluate from a health economic perspective, innovations and healthcare interventions generated from the Hospital Trusts
- Work with NHSIL Partnership Liaison Managers to establish relationships with key NHS management to help identify and obtain patient data sources to carry out projects
- Project management of studies to ensure timelines and milestones are met
- Attending external client meetings, conferences and specialist Health economic events when required to promote and build the Health Outcome Unit’s reputation
The Company is sited at refurbished, air conditioned offices in central London. To apply please visit the web-site at www.nhsinnovationslondon.com and e-mail an application form together with a detailed CV.
We are committed to appointing on merit, seeking candidates from a diverse range of backgrounds and taking full account of equal opportunities.
Tags: health economics, health economist jobs, health outcomes, nhs, nhs jobs, pharmaceutical jobs, pharmaceutical recruitment, Xcelerate Health Outcomes
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Monday, October 19th, 2009
An exciting Regulatory Affairs Senior Consultant role has arisen at an internationally recognised market leader in the Pharmaceutical industry. This Regulatory Affairs job is based in leafy Surrey with excellent transport links to London.
Working as a Senior experienced Regulatory expert with particular expertise in the Biotechnology and Biopharmaceutical sectors, you will have experience of EU MAA submissions through the EMEA Centralised Procedure as well as requesting Scientific Advice on development programmes from the CHMP.
On a day-to-day basis you will be responsible for:
- Providing strategic input into drug development programmes across a wide range of therapeutic areas and product types.
- Authoring CHMP Requests for Scientific Advice and EU Health Authority Briefing Documents.
- Providing input from a Regulatory perspective on cross-functional teams, working closely with clinical, non-clinical and manufacturing colleagues.
This challenging role will offer the opportunity to work on novel medicines across many therapeutical areas with clients all over the world. Whilst this is primarily an office based job, there is the opportunity for international travel. Our prestigeous client also actively encourages membership to various committees and working parties in order to remain at the forefront of the regulatory field.
If you believe you are the right person for the job, please contact Jonathan Hart-Smith on 0845 034 3082 or email jhartsmith@ckregulatory.com. Alternatively, to apply click here.
Tags: jobs in regulatory affairs, jobs in surrey, pharma jobs, pharma reg affairs jobs, pharmaceutical industry jobs, pharmaceutical jobs, pharmaceutical regulatory affairs, Reg Affairs Jobs, Regulatory Affairs, regulatory affairs careers, regulatory affairs consultant, regulatory affairs consultant roles, Regulatory Affairs Jobs, regulatory affairs roles
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