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BIVDA - External Affairs Assistant 

Closing Date: 5th May 2015
Salary: Dependent on experience  
Location: BIVDA Headquarters, Central London

About the role
We are looking to recruit an External Affairs Assistant to support the External Affairs Manager and Chief Executive with BIVDA’s stakeholder engagement activity.

About you
Applicants should be motivated, reliable and organised, with good communication skills and a strong, demonstrable interest in healthcare policy. The ability to work flexibly within this small but influential team is essential. Applicants will be educated to degree level in a relevant field, with a minimum 2.1 grade. For the right candidate this is a unique opportunity to grow and develop within the association. 

About BIVDA
The British In Vitro Diagnostics Association (BIVDA), founded in 1992, is the national trade association for companies with major involvement and interest in the In Vitro Diagnostics (IVD) industry. 

The role of BIVDA is to support the activities in the UK of its members and to campaign for a wider understanding of the value of diagnostic testing in healthcare. The office works routinely with politicians, NGOs and the media as part of its external activities.  

Role of the External Affairs Assistant 

Reporting to 
External Affairs Manager

Responsible for
Delivering communications, policy and public affairs support to BIVDA team 

Overall Objectives
Strengthen BIVDA external affairs activity 
Support the in vitro diagnostics sector 

Key Responsibilities 
Support the External Affairs Manager and Chief Executive across public affairs, policy and communications 
Contribute to the Website, Blog & Social Media Campaigns 
Building strong relationships with the BIVDA membership
Maintaining a database of all potential partners and stakeholders
Monitoring stakeholder activity for potential engagement 
Contributing to BIVDA’s weekly member newsletter
Lead on parliamentary and media monitoring 
Support the effective running of Member Working Parties, including the External Affairs Working Party 
Arranging meetings, drafting letters and general support to the Chief Executive as required 
General Administrative support and other duties as required 

Person Specification
Educated to degree level, with a minimum 2:1 grade
Excellent written and oral communication skills 
Interest and expertise in healthcare policy landscape
Good interpersonal skills, able to work well with colleagues, members and stakeholders 
Positive and helpful attitude to work
Attention to detail 
Good IT skills 
Willingness to work flexibly when required

How to apply

Please send your CV and brief Covering Letter by email to Rebecca Bellars at rebecca@bivda.co.uk clearly marking ‘Application WEAA2015’ in title.

Closing Date: Tuesday 5th May 2015
Interviews: The two weeks following closing date
To start ASAP

Abcodia Ltd Job Description – Testing Service Manager

An opportunity exists for an entrepreneurial, commercially driven and experienced diagnostics professional to join a fast-growing company working in the area of early detection of cancer. Abcodia is launching an innovative testing service which accurately assesses the risk that a healthy woman may have ovarian cancer. This service will be underpinned by the ROCA®[1] test which has been validated through the world’s most extensive prospective clinical trial, UKCTOCS[2], involving repeat testing of 202,000 healthy women over a 10 year period.

The Testing Service Manager will have overall responsibility for delivery of the testing service to the UK private healthcare market.

The position will be based in Cambridge, UK, with the possibility of national and occasional international travel.

Company:  

Abcodia Limited has an exclusive commercial licence to the testing algorithm and serum bank derived from or validated through UKCTOCS.  Abcodia is planning to launch this technology as a service in the UK in 2015.

Key responsibilities:

Working closely with Abcodia’s COO, the successful candidate will be working as a key part of a focused scientific and commercial team to lead the day-to-day operation of Abcodia’s ovarian-cancer testing service with the following responsibilities:

  • Overall managerial responsibility for the Cambridge facility and building the team to deliver an accurate, efficient and user-friendly service, including liaison with and management of key sub-contractors and communication with clinicians and patients;
  • Managing all aspects of the testing service flow from clinician registration to delivering results and dealing with exceptions;
  • Ensuring that testing is traceable from receipt through to result output and is performed to relevant standards and within required timeframe, including liaison with notified bodies and external auditors to ensure quality-management standards are properly applied and adhered to;
  • Authorisation of test result outputs, management of recall processes, coordination with finance for billing purposes and implementation and training with respect to Standard Operating Procedues
  • Reporting to senior executives on performance of the service.


Qualification and Experience:

The ideal candidate will have demonstrated experience of customer-focused diagnostic testing, lab systems and team management, with the following attributes:

  • 3-5 years’ experience delivering clinical-diagnostic testing services, perhaps as a part of a diagnostic laboratory service, with a thorough understanding of commercial laboratory testing using immunoassays, and experience in direct, customer-facing service delivery;
  • An excellent understanding of IT systems related to diagnostic test management;
  • Knowledge and application of quality-management systems that meet the requirements of ISO13485 and of data-protection regulations for safe handling of sensitive customer data;
  • Experience in managing and leading a team with a hands-on and flexible approach;
  • Excellent planning, organisational skills and attention to detail and a clear focus on high quality and business achievement;
  • Enthusiasm, thoroughness, diligence and a willingness to take personal responsibility;
  • Degree in a life-science field preferred.

To apply please send a CV and covering letter to info@abcodia.com

[1] ROCA is the acronym for the Risk of Ovarian Cancer Algorithm
[2] UK Collaborative Trial for Ovarian Cancer Screening
Date Posted: 17 April 2015


Cytocell Ltd. — Regulatory Affairs Associate

Cytocell, a leading manufacturer of IVD medical devices for the diagnosis of human genetic diseases and cancer is looking to recruit a Regulatory Affairs Associate, based in Cambridge, to assist in all aspects of regulatory requirements including, risk assessments, co-ordination of performance evaluations, maintaining technical files and preparation of documentation for registration and submission of products for worldwide markets.

Job Description:

To assist the Director of Regulatory compliance to ensure compliance of Cytocell’s products to applicable regulation and standards for the markets into which they are sold.
To assist with registrations and regulatory submissions to regulatory bodies as required.
To assist with the legalisation of documents and other document requested by distributors or regulatory authorities.
To assist with regulatory requirements throughout the design and development and performance evaluation processes ensuring technical files are maintained for all Cytocell’s products.

Tasks and Accountabilities:

  • Completion of technical file documentation
  • Assist with co-ordinating performance evaluation studies including investigational plans, study protocols and reports
  • Assist where required with distributor registrations and with any necessary paperwork to facilitate importing Cytocell’s products.
  • To assist with legalisation of documents
  • Complete paperwork and other requirements for regulatory submissions
  • Be involved in carrying out detailed risk assessments of IVD products
  • Assist in timely reporting of any adverse events to the appropriate authorities distributors and customers

Qualifications and previous experience:

The candidate should have a background in a science related subject as well as some experience of working within a regulated environment such as ISO 13485 and the IVD directive. Experience of technical file documentation within the IVD / Medical Device industry is desirable but is not essential.

Key attributes:

The candidate should 

  • Be a confident communicator with excellent IT skills
  • Have strong attention to detail.
  • Be flexible, well-organised and reliable

Remuneration

Cytocell offers a competitive salary commensurate with qualifications and experience, a performance related bonus scheme and a pensions and healthcare package.

If this role is of interest and you believe you have the relevant experience then please send a copy of your CV to Mrs Darleen Welford:- Cytocell Ltd, 3-4 Technopark Newmarket Road, Cambridge CB5 8PB or d.welford@cytocell.com


Date Posted: 25 March 2015

 

 

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