Sobi
Job title:
Principal Medical Author
Firm
Sobi
Job description
Firm Description
Sobi provides the chance to work at a world pharmaceutical firm centered on specialty prescribed drugs assembly the excessive medical wants of uncommon illness sufferers and offering therapy and companies to them. Our workers come from quite a lot of backgrounds inside analysis, healthcare, trade and the educational sphere.
Job Description
We’re searching for an skilled Medical Author. The position is a everlasting place reporting to the Head of Medical Writing. The Principal Medical Author will present knowledgeable management, strategic considering and communication abilities and experience within the preparation of scientific regulatory paperwork all through drug growth, post-marketing and life-cycle administration.
Lead a strategy-driven method to authoring of the scientific elements of regulatory submissions, making certain a transparent, concise and full scientific content material aligned with the target of the regulatory doc * Assume major duty for preparation of key scientific regulatory paperwork and paperwork supporting main regulatory submissions in addition to responses to regulatory businesses/ well being authorities
- Present management and mission coordination to cross-functional authoring groups, making certain environment friendly supply, prime quality, and regulatory compliance of scientific regulatory paperwork
- Liaise with senior mission workers, prospectively develop a storyboard for the submission, and plan doc growth to supply optimum help for the proposed prescribing info
- Assume a Product Medical Author duty, offering strategic medical writing experience and help to a number of initiatives in a scientific growth program
- Guarantee excessive technical high quality of the paperwork in compliance with in-house technical necessities
- Coach and develop much less skilled Medical Writers
- Oversee and coordinate all Medical Writers aiding on paperwork beneath your duty, together with in-house consultants and Medical Writers at CRO
{Qualifications}
Life Science Grasp´s diploma or PhD * A minimal of 8-10 years’ expertise in regulatory medical writing mixed with scientific and regulatory information, plus in-depth information of regulatory medical writing processes
- Expertise in main advanced international regulatory and scientific writing initiatives, equivalent to advanced CTDs, ODDs, PIPs, briefing paperwork and regulatory responses
- Expertise as lead creator for main US and/or EMA regulatory submissions, together with coordinating the work of different Medical Writers aiding on paperwork beneath your duty
- Clear understanding of scientific growth, together with the phases, processes, and methods used inside a scientific growth surroundings from protocol design by means of regulatory submission and help for marketed merchandise
- Superior information of world regulatory surroundings and processes (key regulatory our bodies, key paperwork, approval processes, security reporting necessities)
Extra Data
Anticipated wage
Location
London
Job date
Wed, 06 Mar 2024 23:38:42 GMT
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