Senior Medical Writer
M
MMSClinical research
Remotely based within ArgentinaFull-TimeSenior
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- At least 3 years of previous experience in the pharmaceutical industry. Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience.
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- At least 3 years of previous experience in the pharmaceutical industry.
- At least 3–5 years of industry regulatory writing and clinical medical writing experience.
- Substantial clinical study protocol experience as lead author.
- Experience leading and managing teams while authoring regulatory documents to aggressive timelines.
- Experience as a project lead or managing a project team.
- Expert proficiency with MS Word, Excel, PowerPoint, and related word processing tools.
- Highly proficient in writing regulatory documents and using client templates and style guides.
- Exceptional writing skills and strong organizational skills, including the ability to multitask.
- A bachelor’s, master’s, or Ph.D. in a scientific, medical, or clinical discipline is ideal.
- Experience with clinical study reports submitted to regulatory authorities is a plus.
- Understanding of clinical data.
- Understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
- Experience with orphan drug designations and PSP/PIPs is a plus.
Responsibilities
- Evaluate and interpret medical literature for study design, statistical significance, scientific rigor, and potential bias.
- Select primary resource materials to support clinical study documents.
- Write and edit clinical protocols, investigator’s brochures, clinical study reports, and subject consent forms.
- Prepare integrated safety and efficacy summaries and Modules 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents.
- Develop presentation materials and publications for medical journals.
- Complete writing assignments on time and maintain assignment timelines and workflow.
- Coordinate project details directly and independently with clients.
- Consult project team members and other departments for information and guidance.
- Contribute to or manage production of interpretive guides.
- Mentor medical writers and other project team members involved in writing.
View Full Description & ApplyYou'll be redirected to the employer's site
