Medical Writer

Job Description

edits and finalizes protocols, investigators brochures, synopses, regulatory documents and related clinical documents such as abstracts posters, presentations and manuscripts.

accomplish primary goal of communicating complex medical information in clear and compliant writing, Medical Writers perform many tasks.

to compile, write, and edit medical writing deliverables covering all phases of clinical research for submission to regulatory agencies.

be able to help write studies for submissions to the FDA.

to collaborate with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.

edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts.

with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents.

closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.

documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance.

closely with the study team to reach consensus on timelines for deliverables

documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance

the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations

all aspects of outsourced or internal CSR production and ensures project delivery.

that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines

and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables

documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system

that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements

or identifies changes, modifications, and improvements to the document preparation, processes and templates in order to improve quality, efficiency, and productivity

with department management to set strategy for meeting department goals

More Info

Education