Medical Writer

Employer
DOCS Global
Location
Buckinghamshire, UK
Salary
Competitive
Closing date
14 Oct 2020

View more

Discipline
Medical Communications, Medical Writing
Hours
Full Time
Contract Type
Permanent
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We would ideally be looking for a well-rounded candidate who can adapt to a variety of tasks across various projects and provide good scientific leadership. The role would primarily support US medical affairs projects (typically CSRs and protocols) and established products (typically rapid turnaround regulatory responses and submission support), but there could also be a need to support EMEA regional studies and possibly R&D, all depends on workload.

It would be a very varied and interesting role - the candidate would not get pigeon-holed into one disease area as is often the problem.

The role would be providing medical writing support to clinical development teams, primarily in regional medical affairs but also in established products and other assigned therapeutic areas. The role would support multiple product/disease areas and a variety of document types, so the candidate must demonstrate a flexible approach to scientific writing.

The key roles and responsibilities are outlined below:

• Supports development of clinical documents as required, including but not limited to clinical study reports, protocols and protocol amendments, and regulatory responses.
• Acts as a medical writer on single or multiple assigned projects at a simple to complex level across various therapeutic areas.
• May act as a lead writer on projects, providing internal support and/or oversight to external writers.
• Provides scientific and medical writing support and leadership to assigned product teams.
• Leads project teams in drafting document specifications, medical writing standards
and requirements, and coordination and interpretation of data analysis.
• Schedules and leads peer and team review, and addresses independent quality- control review for assigned projects.

The ideal candidate would have a strong scientific background, preferably with a higher degree (but not essential), and have about 2 years of relevant scientific writing experience. Experience in preparation of clinical documentation, though preferred, is not essential.

Education and Experience Requirements/Qualifications:
• Advanced degree in a relevant scientific/clinical/regulatory field preferred
• At least 5 years of pharmaceutical industry experience in the clinical/regulatory field
• Global regulatory submission experience.
• Excellent writing skills.
• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
• Knowledge of current requirements and guidelines applicable to submission documents
• Excellent interpersonal and oral communication skills.
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
• Ability to prioritize multiple projects

#medicalwriterjob

DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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