Medical Writer at Parexel
Position Overview: As a Medical Writer at Parexel, you will utilize your scientific expertise, writing abilities, and patient-centered approach to communicate complex scientific data effectively to regulatory agencies, medical professionals, and the general public. This role involves collaborating with cross-functional teams to develop a wide range of clinical research documents, including clinical study reports, pharmacovigilance documents, informed consent forms, and others. You will be pivotal in producing high-quality, regulatory-compliant documents that support the progression of clinical trials and product safety.
At Parexel, we cultivate an inclusive, supportive work environment that promotes personal and professional growth. Through mentorship, job shadowing, job rotations, and stretch assignments, you'll have ample opportunities to expand your skill set and advance in your career based on global standards and a personalized development plan.
Success Profile
Are these qualities you possess to succeed at Parexel?
Adaptable: Ability to adjust to changing requirements and project demands.
Communicator: Excellent verbal and written communication skills for presenting complex information.
Consistent: Deliver reliable, high-quality results in all aspects of the job.
Deadline-Oriented: Manage deadlines effectively while maintaining accuracy and attention to detail.
Detail-Oriented: Focus on precision and thoroughness in every task.
Insightful: Ability to draw informed conclusions from data and information.
About This Role
Job Purpose:
In this role, you will be responsible for the preparation and management of a variety of safety and regulatory reports, including periodic safety update reports (PSURs), benefit-risk evaluations (PBRERs), safety statements, risk management plans (RMPs), and clinical study reports (CSRs). You will also contribute to the signal detection process and collaborate with both internal and external teams to ensure that documents meet regulatory standards.
Key Responsibilities
Aggregate Reports Management:
Prepare, update, and merge periodic safety reports (PSURs), PBRERs, and related safety and risk management documents, ensuring compliance with client requirements and SOPs.
Conduct systematic literature reviews focusing on epidemiology, providing valuable data for inclusion in safety reports.
Generate line listings and resolve discrepancies to ensure the accuracy of data presented in reports.
Ensure high-quality, error-free drafts before distribution to teams or clients.
Clinical Study Report (CSR) Narratives:
Develop and write clear and medically cohesive narratives based on clinical database and safety database outputs.
Perform quality checks and collaborate with teams to ensure accurate, high-quality narrative delivery.
Signal Detection and Management:
Conduct qualitative and quantitative signal detection reviews from various data sources (e.g., regulatory databases, client databases, literature).
Lead signal management activities, including tracking and assessment, and present findings in review meetings.
General Responsibilities:
Stay informed about global regulatory requirements and maintain an understanding of the adverse event safety profiles of assigned drugs.
Ensure adherence to client timelines and regulatory obligations for all deliverables.
Participate in internal training sessions and audits to maintain compliance with regulatory standards.
Provide mentorship to junior team members as needed.
Skills & Experience
Analytical Skills: Strong ability to interpret data and apply it to generate conclusions.
Interpersonal Skills: Strong communication and teamwork abilities to collaborate effectively with internal and external stakeholders.
Organizational Skills: Proficient at managing multiple tasks, prioritizing, and meeting deadlines in a fast-paced environment.
Client-Focused: Understand client needs and ensure satisfaction with high-quality deliverables.
Technical Proficiency: Skilled in MS Office Suite (Word, Excel, PowerPoint), web-based applications, and familiar with Windows operating systems.
Education and Knowledge
Degree: A minimum of a university degree in life sciences, health, or biomedical sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics).
Additional Qualifications: A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing with patient exposure is a plus.
Experience: Prior experience in regulatory, pharmacovigilance, or medical writing is preferred. A strong understanding of medical terminologies is essential.
Location:
#LI-REMOTE - This position offers remote work flexibility.
Why Join Parexel?
At Parexel, you'll be part of a dynamic team that’s helping to improve the health and lives of people worldwide. Join us to be a part of cutting-edge medical writing and regulatory affairs and make an impact on clinical trials and product safety worldwide.
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