Opportunities

Regulatory Writer

Due to significant growth in demand for our services, we are seeking to expand our highly accomplished writing team. We have a permanent full-time position for a Regulatory/Medical Writer to work across the complete spectrum of healthcare fields, disease areas and types of documentation (predominantly medicinal products and devices, but also cosmetics, nutraceuticals and alternative therapies, for example).

The ideal candidate will have the following attributes:

• Graduate scientist in a life science (a biological science, pharmacy, pharmacology, or chemistry), preferably at an advanced (MSc or PhD) level;
• At least 5 years experience in medical/regulatory writing gained within the pharmaceutical industry or CRO environment, with a proven track record of achievement across a range of therapy areas and/or document types;
• Understanding of the principles of drug development and appreciation of the current regulatory environment including applicable regulatory guidelines. The ideal candidate will have experience across at least two ICH regions (i.e. Europe, USA, and/or Japan). Experience of working with emerging markets, especially BRIC countries, will be considered favourably;
• Customer-focussed approach - ability to solve problems, instil confidence, and gain trust;
• Excellent command of English and strong organisational, communication, literacy and numeracy skills; ability to manage and prioritise multiple tasks, often to tight deadlines;
• Keen eye for detail; ability to assimilate large volumes of data and produce clear, accurate and compelling text in compliance with regulatory requirements;
• Understanding of the more common statistical approaches used in clinical development;
• High-level awareness of current practice in medical writing, medical information techniques, and technology relating to preparation of all levels of documentation; strong word processing skills, document compilation using Adobe Acrobat;
• Ability to work independently or in a team, and assume responsibility for project management when required.

You should be able to demonstrate experience in preparation of documents such as:

• Clinical Study Protocols and Reports - Phases I-IV, and non-interventional studies;
• All components of the common technical document (CTD), especially module 2 and 5 documents; familiarity with eCTD templates;
• Paediatric investigation plans (PIPs);
• Investigator brochures;
• Clinical Trial Applications (CTAs) including Investigational Medicinal Product Dossiers (IMPDs);
• Patient information leaflets and informed consent forms;
• Periodic Safety Update Reports (PSURs), Risk Management Plans, signal evaluation write-ups and case narratives;.
• Clinical Evaluations and Technical Files for medical devices;
• Health Technology Assessment (HTA) and core value dossiers;
• Digital messaging, e.g. website pages, patient reported outcomes.;

Additional experience in the following areas, while not essential for the successful candidate, is very desirable:

• Advising on regulatory strategy, e.g. in relation to marketing authorisation submissions, medical device applications, PIPs, CTAs, etc;
• Submissions experience such as submission publishing and submission of CTAs via EudraCT;
• Writing Standard Operating Procedures (SOPs);
• Quality control (QC).

If you would like the opportunity to be part of a successful, busy, dedicated and growing team, and to make a direct and positive contribution to further growth and development of our medical writing and regulatory affairs services, please send your CV and a covering letter to jsouth@spectrumrs.com or call +44 (0)1403 320280 for further information.

Careers

If you would like to learn more about a career at Spectrum please telephone Personnel on +44 (0)1403 320280 or email personnel@spectrumrs.com.

Rewards at Spectrum are commensurate with experience and the ability to deliver. All applications will be treated with the strictest confidence.

Collaboration

Spectrum is always interesting in hearing from experienced regulatory affairs, medical writing and pharmacovigilence candidates for both permanent and project based assignments.

Please contact us by sending a copy of your current CV to regulate@spectrumrs.com.

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