Description
Start Date: ASAP
Duration: 6 month Contract
Rate: 240 per day
Location: Stockley Park, Uxbridge, UK.
Basic qualifications:
Bachelor of Science
* Has good theoretical understanding of research principles within a particular area of medicine or science.
* Demonstrates solid scientific technical expertise and the ability to independently apply new knowledge and operational processes accordingly.
* Possesses excellent writing skills
* Possesses excellent computer skills, literacy, technical and statistical skills.
* Understands and is able to independently analyse/critique/assess trends and patterns in both text and statistical data and communicate findings clearly and succinctly in writing to a scientific/medical and ideally regulatory audience.
* Ability to prioritise effectively and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the Matrix, ensuring standards are proactively applied across a submission
Preferred qualifications:
PhD, PharmD, MPH, MS or other post-graduate life science degree preferred
Details:
This position will offer the individual an opportunity to focus on the medical writing needed in late stage clinical development projects. The individual will gain exposure to and interact with members of global Clinical Project teams, including Clinical, Contract Research Organizations, Global Regulatory Affairs, Safety and Statistics colleagues
Responsibilities will vary but may include:
* Support the preparation of critical regulatory documents for US, EU and Emerging Markets/Asia Pacific including clinical summaries of efficacy and safety, clinical overviews, clinical study reports, investigators brochures, briefing documents, for regulatory meetings,
* Support company transparency and disclosure obligations including, CTR summaries*
* Effectively organises content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions.
* Ability to become familiar with relevant company policies, SOPs, tools, and terminology associated with the creation and management of regulatory and disclosure documents
* Be familiar with ICH guidelines for Common Technical Document and Code of Federal Regulations for New Drug Applications and FDA requirements.
* Ability to become familiar with new projects quickly and become familiar and get up to speed quickly when moving between projects. May work on multiple projects at one time.
Please note this is an opportunity to cover a maternity leave until end December 2012.