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Senior/Principal Regulatory Writer - Home, Macclesfield - Complete Regulatory

Business Type: Medical Communications Agency
Job Type: Medical Writing and Editorial, Regulatory Affairs
Job Level: Experienced (non manager)
Position: Full Time
Location: Cheshire
Reference: REGLTD/SPRW/1877
Job Details:
Recruiting for an Autumn 2020 start date

Macclesfield, possibility of part time and/or part home working

At Complete Regulatory, part of McCann Health we partner with global pharmaceutical and biotechnology clients to provide expertise in strategic consultancy, multi-channel medical communications and regulatory documentation.  Our vision is to bridge the clinical care gap by combining insight and scientific evidence, to improve healthcare outcomes for patients and to enhance the clinical and commercial success of our clients.

We provide class-leading writing support and consultancy services to the pharmaceutical industry. We produce a wide range of clinical documentation, including clinical study reports, protocols, clinical summaries, clinical overviews, briefing documents, regulatory responses and other supporting documents, across a variety of therapy areas.

We are looking for an experienced Regulatory Writer to join our team and help us to build on our continuing success.  You will use your thorough knowledge of FDA, EMA and ICH guidelines to write a wide range of regulatory documents; these will include strategic requirements, such as clinical overviews, higher-level summaries and briefing documents.

Our clients value our services very highly and in this role you will work as a trusted partner with various companies, to provide leadership and support on a range of project types and therapy areas.  You will help to maintain our excellent client relationships, which will allow you to consult with the client and demonstrate your high-level strategic thinking, based on extensive past experience, to ensure effective medical writing for regulatory authorities.

We are looking to recruit enthusiastic individuals with clever and curious minds. Applicants should be life-science graduates, ideally with a PhD or other research experience, although this is not mandatory.  You will need at least 3 years'' experience as a regulatory writer within the pharmaceutical industry and/or a medical writing agency. 

As the successful candidate, you will be a highly valued member of the Regulatory Writing team and will have the opportunity to advance your skills while helping less experienced team members to achieve their potential, by providing coaching and insight.  We take great pride in our strong team ethic and our commitment to quality and, therefore, these are the personal attributes we look for in anyone joining the Complete Regulatory team.

This position will benefit anyone looking to build on their experience in regulatory writing, while working within a highly specialised, supportive and reputable team.  In addition, you will become part of a larger organisation, which offers a range of world-class services and a flexible organisational structure.

We offer you a fresh challenge in your career, within a supportive working environment. As well as a competitive remuneration and benefits package, we provide long-term career choice and development that supports and encourages our staff to progress and maximise their potential. Ultimately, whoever you are, whatever difference you can make to our business, our aim is to provide you with an environment that is thriving and challenging, flexible and inclusive, with a culture where opportunities and success abound.

If you are passionate about exceeding expectations and want to make a real contribution within a dynamic and caring medical communications company, then we would welcome your application.

At McCann Health Medical Communications, we welcome applicants with disabilities. Please advise us of any support needs you have at interview stage.

We are McCann Health, one of the most awarded global healthcare communications networks. We believe that Diversity and Inclusion are foundational to achieving our mission – to help our client’s brands and businesses play a meaningful role in people’s lives. We view diversity as a business imperative that, when incorporated into all agency practices, becomes a competitive advantage, driving growth and organizational sustainability. As we position ourselves for a future of increased competition and disruption, we’re accelerating beyond merely acknowledging differences. Our philosophy is that consistent practices and deliberate actions that foster an inclusive culture, unleash the creative power of our talent and our work. We call this Conscious Inclusion.

Posted: 03/06/2020 | NPJ Ref: 254789
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