Principle Medical Writer

Regulatory Professionals
London (Greater)
11 Jan 2018
10 Feb 2018
Contract Type
Full Time
Principle Medical Writer
Location: London or Homebased
Salary: Competitive and DOE

Regulatory Professionals are currently working with a rapidly growing consultancy based in London. They are looking for a Senior and Principle Medical Writer to join the team. Working as part of a high performing department the successful candidate will be responsible for authoring, editing and peer review of medical writing documents
Duties and Responsibilities:
* Undertakes project specific activities at high quality and within defined timelines according to defined standard processes and operating procedures.
* Clinical study documents or documents for regulatory submission e.g., protocols, clinical study reports, patient narratives, and Investigator brochures.
* External scientific communications e.g., manuscripts, abstracts, standard response documents, FAQs, response to authorities.
* May independently author or lead authoring of complex documents such as INDs, clinical summaries and overviews, briefing documents, response to authorities, and PIPs.
* Displays good decision making skills and ability to solve problems as related to document writing and timelines.
* Participates in, and may lead, meetings with clients as required to understand expectations, establish trust and confidence with client counterparts.
* Supports the development and refinement of process documents, including associated training materials, with direction from Development Operations leadership.

* Degree, or advanced level degree in a life science discipline
* Experience and technical skills within Medical Writing within a pharmaceutical company or CRO.
* Strong analytical capabilities, familiarity and comfort with scientific and clinical data.
* Commitment to ensuring the highest quality outputs are provided, including high attention to detail
* Strong knowledge of basic computer applications, e.g., MS Word/ PowerPoint/ Excel.
* Significant knowledge of regulatory requirements or guidance pertaining to medical writing or medical Information
* Effective team member, and matrix leader for small teams
* Excellent relationship building, and communication skills
* Excellent verbal and written communication skills

Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then you`ll receive £250 worth of vouchers of your choice.

Regulatory, Medical Writing, Medical Writer, CTD, Clinical Study Reports, Regulatory Submission, Home Working, London