This innovative Pharmaceutical Company is a very well-funded subsidiary of a global behemoth (Europe and Asia), and is committed to become a fully integrated company in the U.S. The Senior Medical Writer, Regulatory position is open due to expansion, and the company is looking to fill the position quickly. The company already has an impressive pipeline with drugs in Phase III and II. This an exciting time to contribute, and grow with the company. The company provides extraordinary benefits including 100% company-paid Health Benefits.
Summary of the Position:
• The Senior Medical Writer, Regulatory authors the development of clinical documents in accordance with all applicable regulations, and ensures coordination and integrations of the scientific, medical and regulatory input from development team members.
Essential Job Responsibilities:
• Leads the planning and completion of Regulatory submissions globally
• Cross-functional leadership responsibilities with regulatory and clinical teams to ensure development and submissions of CSR’s, IND’s and NDA’s
• Ensure that all documentation and messaging is consistent
• Required Education: PharmD OR PhD OR MD degrees, OR MS (with 2 years relevant exp) OR BS degree (with 5+ years relevant experience)
• Proven track record of authoring and managing US IND’s, Clinical Study Reports (CSR’s) within Phases I, II, III and Investigator Brochures (IB’s)
• Experience analyzing clinical data, and managing timelines
12 freelancers are bidding on average $143 for this job
I have briefly read the description on research development, and I can deliver as per the requirements however I need us to discuss for more clarity on the details, deadline and budget as well.
Hello.. i am a professional and senior medical writer and have 6 years of writing experience. I am dealing academic research papers since long for the UK and US clients.. Hire me
I charge $100 for two days' job. Relevant Skills and Experience I am a medical professional (MD) with an experience of 20 years, working in the fields of both neurologist and physiology.