Medical Writer (Contractor)
New
J
JobgetherPharmacovigilance
Based in the United StatesContractJunior
Salary not disclosed
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Job Details
- Experience
- At least two years of professional medical writing experience; two to six years of experience is preferred.
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree or equivalent qualification in life sciences, pharmaceutical sciences, medicine, or a related discipline.
- At least two years of professional medical writing experience; two to six years is preferred.
- Familiarity with authoring and reviewing aggregate safety reports, including PSURs, PBRERs, DSURs, PADERs, and annual safety reports.
- Understanding of drug safety regulations, pharmacovigilance practices, safety surveillance, risk management, and regulatory reporting requirements.
- Experience with Risk Management Plans, Clinical Study Reports, clinical protocols, labeling documents, or related regulatory materials is advantageous.
- Ability to interpret clinical and non-clinical safety information, conduct literature searches, and contribute to signal detection and risk assessment.
- Working knowledge of Microsoft Office, particularly Word, Excel, and Outlook.
- Strong written, verbal, and presentation skills for communicating complex scientific information.
- Strong attention to detail, time management, and prioritization skills, including managing multiple assignments and deadlines.
- Ability to collaborate across multidisciplinary teams and build productive relationships with internal and external stakeholders.
- Willingness to occasionally work extended or flexible hours to meet client requirements and critical deadlines.
Responsibilities
- Analyze clinical and non-clinical safety data and relevant scientific sources.
- Author and review PSURs, PBRERs, DSURs, PADERs, Canadian annual reports, safety update reports, and addenda to clinical overviews.
- Prepare and review Risk Management Plans and related risk documentation.
- Develop and review Clinical Study Reports, clinical study protocols, labeling documents, and other clinical and regulatory materials.
- Conduct qualitative and quantitative signal assessments for medicinal products.
- Search, assess, and summarize scientific publications for pharmacovigilance deliverables.
- Generate Periodic Safety Line Listings from safety databases and maintain process trackers.
- Coordinate drug safety communications with Regulatory Affairs and other stakeholders, and contribute to responses to regulatory agency and PRAC inquiries.
- Verify deliverables against regulatory requirements, quality standards, and project timelines.
- Provide medical writing and pharmacovigilance guidance, training, and mentoring to colleagues.
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