CLINCHOICE Salary
UNIT G48 268 BATH ROAD SLOUGH SL1 4DX UNITED KINGDOM
TIN: 09129911
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Earnings on positions in CLINCHOICE
CLINCHOICE is looking for employees for positions:
writer
Trade
- medical Information
- Medical Information
Language
- english
Responsibility
- the Director of Medical Writing will lead the medical writing function and will coach and grow the team
- the Director will conduct senior review of medical writing deliverables and negotiate timelines and discuss/resolve clients' comments
- this role will provide written and verbal feedback to the internal team, and to clients when appropriate
- lead the medical writing team- mentor the team and oversee all the aspects of project delivery for global clients
- the Director may function as a Lead Medical Writer on a variety of regulatory writing deliverables; will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines
- manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
- present on Medical Writing processes at full-service bid defense meetings
- she/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice /AMWA/EMWA along with developments and advances in clinical drug development
Education
- at minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred
- at least 10 to 15 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills
- an understanding of the drug development process
- broad experience managing the medical writing responsibilities associated with multiple studies at various stages
- experience in interacting with cross functional study team members
- experience working on end-to-end CSR, IBs, Protocols across different TAs is mandatory for pharmaceutical and medical device products. Experience in DSUR will be considered as an added advantage
Requirements
- excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
- able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely
- ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards
- ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
- ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed client and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately
- be able to juggle multiple priorities and adapt quickly to new situations and new project demands
- culturally aware and able to work comfortably within a global team