The posting
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Medical Writer (Contractor) based in the United States.
As a Medical Writer, you will contribute to the development and maintenance of high-quality clinical and drug safety documentation supporting pharmaceutical product development and post-marketing surveillance. You will analyze clinical and non-clinical safety data, prepare regulatory reports, and help ensure compliance with global pharmacovigilance requirements. Working alongside drug safety professionals, clinical research teams, and regulatory specialists, you will play an important role in protecting patient safety and supporting informed regulatory decisions. This contract opportunity offers exposure to diverse therapeutic areas and a variety of medical and regulatory documents. You will also contribute scientific expertise to signal assessment, risk management, and safety reporting activities. Ideal for a detail-oriented medical writing professional, this role combines scientific rigor, regulatory knowledge, and cross-functional collaboration in a technology-enabled life sciences environment.
Accountabilities:
- Analyze and interpret safety data: Review clinical and non-clinical safety data, alongside relevant scientific sources, to support accurate, evidence-based pharmacovigilance documentation and regulatory submissions.
- Prepare aggregate safety reports: Author and review periodic and development safety reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Canadian annual reports, safety update reports, and addenda to clinical overviews.
- Develop risk management documentation: Prepare and review Risk Management Plans (RMPs) and related documents to support the assessment, communication, and mitigation of potential product safety risks.
- Author clinical and regulatory documents: Develop and review Clinical Study Reports, clinical study protocols, labeling documents, and other materials supporting clinical development, regulatory submissions, and post-marketing product maintenance.
- Conduct signal detection and assessment: Perform qualitative and quantitative signal assessments to identify, evaluate, and communicate potential safety concerns associated with medicinal products.
- Conduct scientific literature reviews: Search, assess, and summarize relevant scientific publications, incorporating appropriate evidence into aggregate reports and other pharmacovigilance deliverables.
- Support safety reporting operations: Generate Periodic Safety Line Listings (PSLLs) from safety databases and maintain accurate process trackers, ensuring effective documentation management and reconciliation.
- Coordinate regulatory and safety communications: Collaborate with Regulatory Affairs and other stakeholders to support appropriate reporting of drug safety information to health authorities and the prescribing community.
- Respond to regulatory inquiries: Contribute to responses to regulatory agency questions and Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, providing clear, accurate, and scientifically supported information.
- Ensure quality and timely delivery: Verify that all client deliverables meet applicable regulatory requirements, internal quality standards, and agreed project timelines.
- Provide subject matter expertise: Serve as a medical writing and pharmacovigilance resource, offering guidance, training, and mentoring to colleagues and pharmacovigilance associates.
- Support evolving business needs: Contribute to high-priority ad hoc assignments, adapt to changing project requirements, and collaborate effectively with clinical research organizations (CROs), partner teams, and other stakeholders.
- Education: Bachelor's degree or equivalent qualification in life sciences, pharmaceutical sciences, medicine, or a related discipline.
- Medical writing experience: At least two years of professional medical writing experience, ideally within pharmaceutical development, clinical research, drug safety, or pharmacovigilance. Two to six years of experience is preferred.
- Regulatory writing expertise: Familiarity with authoring and reviewing aggregate safety reports, including PSURs, PBRERs, DSURs, PADERs, and annual safety reports, is highly desirable.
- Pharmacovigilance knowledge: Understanding of drug safety regulations, pharmacovigilance practices, safety surveillance, risk management, and applicable regulatory reporting requirements.
- Clinical documentation experience: Experience preparing or reviewing Risk Management Plans, Clinical Study Reports, clinical protocols, labeling documents, or related regulatory materials is an advantage.
- Safety data analysis: Ability to review and interpret clinical and non-clinical safety information, conduct literature searches, and contribute to signal detection and risk assessment activities.
- Regulatory interaction experience: Exposure to health authority inquiries, PRAC-related questions, or other regulatory communications is beneficial.
- Technical proficiency: Good computer skills and working knowledge of Microsoft Office applications, particularly Word, Excel, and Outlook.
- Communication skills: Excellent written, verbal, and presentation skills, with the ability to communicate complex scientific information accurately and clearly.
- Organizational abilities: Strong attention to detail, time management, and prioritization skills, with the ability to manage multiple assignments and meet deadlines.
- Collaboration and relationship management: Ability to build productive relationships, work across multidisciplinary teams, and communicate effectively with internal and external stakeholders.
- Adaptability and initiative: A proactive, resourceful, and collaborative approach, with the flexibility to respond to changing business priorities and urgent project requirements.
- Mentoring and knowledge sharing: Ability or willingness to provide subject matter guidance and support the training and development of colleagues.
- Schedule flexibility: Willingness to occasionally work extended or flexible hours when necessary to meet client requirements and critical project deadlines.
- Work arrangement: Ability to support remote contract assignments serving teams and clients within the scope of the engagement.
- Competitive hourly compensation based on medical writing and drug safety experience.
- Remote working arrangement.
- Flexible, as-needed contract engagement, with assignments and extensions defined through a Scope of Work consulting agreement.
- Opportunity to contribute to pharmaceutical product safety, clinical development, and regulatory compliance.
- Exposure to diverse pharmacovigilance activities, scientific documentation, and regulatory reporting requirements.
- Collaboration with experienced drug safety professionals, clinical research teams, and regulatory specialists.
- Opportunities to strengthen medical writing expertise and contribute subject matter knowledge across projects.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1
