Medical Writer – Contractor

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Develop documentation for pre-marketing and post-marketing clinical trials, medical affairs, safety data, product development, license applications, and ongoing post-marketing activities.

• Evaluate, review, and interpret non-clinical and clinical safety data along with other pertinent sources.

• Write and review comprehensive reports, including PSURs/PBRERs, PADERs/Annual Reports/ACO/DSURs, and additional safety reports for submission to health authorities.

• Draft and assess Risk Management Plans.

• Prepare and review clinical documents such as Clinical Study Reports and Protocols.

• Conduct qualitative and quantitative signal assessments.

• Execute literature searches and compile relevant articles for aggregate reports.

• Manage and reconcile associated process trackers.

• Act as a subject matter expert while training and mentoring team members.

• Generate Periodic Safety Line Listings using safety databases.

• Address inquiries from regulatory agencies and the Pharmacovigilance Risk Assessment Committee.

• Provide dependable support for high-priority ad-hoc tasks.

• Ensure that client deliverables align with regulatory requirements and are dispatched within agreed timelines.

• Collaborate with Regulatory Affairs to report pharmacovigilance and drug safety information to regulatory organizations and prescriber communities.

• Train and mentor associates in Pharmacovigilance.

⛳️ Requirements

• At least 2 years of experience in Medical Writing.

• A degree in Life Science/Pharma or an equivalent qualification.

• Strong computer proficiency and keyboarding skills.

• Proficient in Microsoft Office Suite (Outlook, Word, Excel).

• Excellent verbal, written, and interpersonal communication abilities.

• Strong organizational and prioritization skills; capable of multitasking.

• Flexibility to adapt to changing business priorities.

• Willingness to occasionally work extended and/or flexible hours to meet client needs.

• Ability to build relationships, collaborate, and influence across various disciplines within Sitero and with external stakeholders.

• Outstanding verbal, written, and presentation skills.

• Innovative, collaborative, and proactive in taking initiative.

🏝️ Benefits

• Competitive hourly rate based on experience level in Drug Safety medical writing.

• Contract agreement on an as-needed basis, extended through a Scope of Work consulting document.