We are looking for Clinical Medical/Technical Writer III 6 months contract Role Alpharetta GA. Will assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
Responsibilities for Clinical Medical/Technical Writer III:
· Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, clinical study reports; and technical dossiers
· Conducts comprehensive literature evaluations, product complaint reviews, and other product specific information to compile literature based clinical evaluation reports.
· Manages study team participation in the preparation of such documents, including calling/running meetings, developing timelines, and managing the document review and comment adjudication processes Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials.
· Sit side-by-side and work with several members of our team to create in-depth processes maps and standard works for processes that are relatively simple to fairly complex.
· Test documentation for accuracy and consistency.
· Identify areas that may require additional process improvements or documented structure and develop thoughtful recommendations for execution.
· Utilize Great Plains ERP system to include graphical instructions along with written detail to deliver the appropriate level of detail for both audit purposes and new user training.
· One key focus of this position will be the drafting and publication of relevant data in high-quality peer-reviewed journals. Additionally, the Medical/Scientific Writer- Scientific Communications will assist in the drafting of white papers and other pieces of communications collateral which aim to deliver our scientific message to key stakeholders.
· This role will report into the Scientific Communications Manager and regularly liaise with key internal personnel in relevant business units, including acute and chronic pain, digestive health and respiratory health.
· The Writer will independently craft pieces that ladder up to the overall scientific communications strategies for each business unit.
· Publication planning, identification of target journals and editorial guidelines
· Drafting of manuscripts, participation in steering committee meetings and incorporating investigator feedback
· Managing submission process, subsequent edits and resubmission in a timely manner