Medical Writer (Contractor)
Sitero LLC•Raleigh, NC
•Remote
About The Position
The Medical Writer creates documents for pre-marketing and post-marketing clinical trials, medical affairs, and safety data to support product development, license applications, and post-marketing maintenance. The role authors and reviews documents including aggregate reports, Risk Management Plans, signalling and labelling documents, Clinical Study Reports, and protocols. The Medical Writer is part of Sitero’s safety professionals and collaborates closely with safety teams at Contract Research Organizations and with partners. The role requires maintaining relevant medical knowledge and current knowledge of drug safety and pharmacovigilance regulations, practices, safety surveillance, and risk management.
Requirements
- Minimum 2 years of experience in Medical Writing.
- Degree in Life Science, Pharma, or equivalent.
- Proficient computer and keyboarding skills.
- Proficiency with Microsoft Office Suite, including Outlook, Word, and Excel.
- Strong verbal, written, interpersonal, and presentation skills.
- Strong organization and prioritization skills, with the ability to multitask.
- Flexibility to adapt to fluctuating business priorities.
- Ability to occasionally work an extended and/or flexible schedule to meet client requirements.
- Ability to build relationships, collaborate, and influence across disciplines within Sitero and with external stakeholders.
- Innovative, collaborative, and able to take initiative.
Nice To Haves
- Preferred 2–6 years of experience in Medical Writing.
Responsibilities
- Analyze, review, and interpret non-clinical and clinical safety data and other relevant sources.
- Author and review aggregate reports, including PSURs/PBRERs, PADERs/Annual Reports, Addenda to Clinical Overviews, and DSURs, for submission to local and other Health Authorities.
- Author and review Risk Management Plans as needed.
- Author and review clinical documents, including Clinical Study Reports and protocols.
- Perform qualitative and quantitative signal assessments.
- Search the literature and present relevant articles for aggregate reports.
- Manage and reconcile relevant process trackers.
- Serve as a subject matter expert and train and mentor individuals.
- Generate Periodic Safety Line Listings from the safety database.
- Handle regulatory agency and Pharmacovigilance Risk Assessment Committee inquiries.
- Provide reliable support for high-priority ad hoc activities.
- Ensure client deliverables comply with relevant regulatory requirements and are sent within agreed timelines.
- Collaborate with Regulatory Affairs on appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and the prescriber community.
- Train and mentor Pharmacovigilance associates.
Benefits
- Hourly rate commensurate with Drug Safety medical writing experience level.
