The main function of a medical writer is to develop accurate and effective Clinical, Scientific, and Regulatory documents and presentations for external scientific conferences and meetings
Key Responsibilities :
Research, create, and edit moderately complex scientific publications and presentations of clinical research based on input from the Clinical Team, Key Opinion Leaders (KOLs), and physician investigators
Write moderately complex clinical documents for submissions, including but not limited to : briefing documents, previous human experience summaries, investigator brochures, and interim and final clinical study reports for the assigned projects
Provide guidance to the Clinical team to develop the publication strategy and plans; create and may edit publication for all clinical studies in collaboration with KOLs
Conduct literature searches, managing the literature database and prepare literature reviews for external and internal clients
Review draft publications for accuracy and continuity with previously published work and submitted regulatory documents
Project Lead for medical writing deliverables for assigned clinical studies. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues
Other incidental duties assigned by Leadership
Additional Skills :
Ability to provide leadership and guidance; skilled in coaching and training techniques
Good computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)
Good editing and proofreading skills
Good written and verbal communication skills including negotiating and relationship management skills
Good problem-solving and critical thinking skills
Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques
Moderate knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)
Moderate knowledge of statistics
Strict attention to detail
Ability to interact professionally with all organizational levels and functions where appropriate
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence / control
Education and Experience :
Bachelor's Degree or equivalent in in related field