Associate Director, Global Regulatory Affairs (CMC) IV

Posted Jan 22, 2020
Project ID: SHPGJP00004757
Lexington , MA
1 year
(Feb 3, 2020 - Jan 31, 2021)
40 hrs/week
Payrate range
True job title is MEDICAL WRITER

Description: Role is Part-Time (20 hours/week) Role is expected to last 6 months Role to be REMOTE ***************** Summary: With oversight, the position supports the preparation of clinical documents that are of high quality and prepared within timelines. Essential Duties and Responsibilities: 1) With oversight, supports the preparation of clinical documents. The development process may include writing, interpreting and summarizing clinical and non-clinical data, and compiling information. Clinical documents may include investigator brochures, clinical study reports, integrated reports, summary reports, manuscripts, abstracts, posters, and presentations. 2) May participate in ensuring compliance of clinical documents with national and international regulatory requirements and guidelines and procedures (as applicable). Includes collaborating with medical editors to ensure documents are publication ready. 3) Develop knowledge of all therapeutic areas. Qualifications: The Medical Writer I must demonstrate: � Excellent scientific and/or medical writing skills � Experience in the analytical evaluation of scientific data � Exceptional organizational skills and meticulous attention to detail The Medical Writer I must be able to: � Manage multiple projects with competing priorities � Work in a team environment The Medical Writer I also should possess knowledge of computer software (especially Microsoft Word and Adobe Acrobat products; Microsoft Project and Visio are a plus). The Medical Writer I may require up to 5% travel. Education and/or Experience: The Medical Writer I must have an academic science or clinical degree (eg BS) and exceptional writing skills, and preferably experience in scientific/medical research.