Extensive experience writing all types of clinical and regulatory documents for worldwide use, expertise in the Oncology therapeutic areas, experience in worldwide registration studies and large studies, understanding and good use of all study documents.
Protocol, SAP, CRF, SMQs, expertise in MS WORD, including the ability to solve technical problems with WORD templates, excellent grammatical and communication skills.
Both written and oral, knowledge of FDA and ICH guidelines, ability to work with multiple complex projects at a time, ability to anticipate and resolve problems working independently,
Experience working with automated data solutions in clinical documents, experience working with CROs, proficiency in data interpretation, sound organizational skills.
Experience interfacing with multiple teams, and proven ability to problem solve and identify inconsistencies or inaccuracies in data listings.
November 27, 2017 – Medical Writer – p b Summary/Scope: /b /p ul li We are looking to add a Medical Writer to our Translational Development team based in San Francisco, CA. /li li
October 30, 2017 – Principal Medical Writer – p b Job Description: /b /p ul li The Principal Medical Writer is responsible for providing project leadership in Medical Writing for one or more
October 30, 2017 – Oracle Business Intelligence Report Writer – p b Summary: /b /p ul li The University of Massachusetts Information technology team (UITS) has delivered a series of Dashboards and reports in
October 30, 2017 – Associate Principal Medical Writer – p b Job Description: /b /p ul li The main purpose of this position is to provide medical writing for clinical and regulatory documentation
August 31, 2017 – Regulatory Writer, Clinical – p b Responsibilities: /b /p ul li Author regulatory submission documents, eg, CSRs, CTD summary documents (2.7.3, 2.7.4, possibly 2.7.1, and
August 31, 2017 – Medical Writer – p b Responsibilities: /b /p ul li Clinical / medical writing experience – pref. in oncology /li li Experience at bringing together submission