Medical Writer - Parexel Consulting
Job Overview
As a Medical Writer at Parexel, you will leverage your scientific expertise and writing skills to effectively communicate complex clinical research data to diverse stakeholders, including regulatory agencies, medical professionals, and the public. Your primary responsibilities will include preparing various clinical documents such as clinical study reports, pharmacovigilance documents, informed consent forms, and more. You will collaborate with cross-functional teams to ensure high-quality, accurate, and regulatory-compliant documentation.
At Parexel, we foster a culture of inclusivity and collaboration, providing opportunities for professional growth through mentorship, job rotation, and challenging assignments. Your development and career progression will be guided by global standards and a personal development plan.
Success Profile
The ideal candidate will have the following soft skills and interpersonal traits:
Adaptable: Able to adjust to evolving requirements and work environments.
Communicator: Strong ability to communicate clearly and effectively, both written and verbally.
Consistent: Reliable and able to maintain high standards of quality in all work.
Deadline-oriented: Ability to manage deadlines and prioritize tasks efficiently.
Detail-oriented: Focused on accuracy and precision in writing and data analysis.
Insightful: Capable of making informed decisions based on data and findings.
About This Role
Job Purpose
The Medical Writer will manage a range of regulatory and clinical documentation, including but not limited to:
Aggregate Reports: Prepare and update periodic safety reports (PSRs), development safety update reports (DSURs), risk management plans (RMPs), and related documents in accordance with client requirements, guidelines, and SOPs.
Clinical Study Reports (CSRs): Develop clear and cohesive narratives from clinical trial data, ensuring compliance with sponsor and regulatory expectations.
Signal Detection and Management: Perform qualitative and quantitative analysis for signal detection and manage the signal management process, collaborating with Global Safety Operations (GSO).
General Duties: Maintain a solid understanding of adverse event safety profiles, regulatory obligations, and client-specific guidelines. Ensure that all work is of the highest quality and delivered within timelines.
Key Responsibilities
Aggregate Reports:
Manage and prepare various safety and regulatory documents such as PSURs, PBRERs, DSURs, and more.
Perform critical reviews of literature and apply epidemiological methods to support safety evaluations.
Ensure data consistency and integrity across reports.
Perform compliance reviews and quality checks before distributing final reports.
Clinical Study Report (CSR) Narratives:
Collaborate with study teams to develop narrative templates and write accurate and medically cohesive narratives based on clinical and safety data.
Conduct quality checks to ensure the highest standards of medical writing are maintained.
Signal Detection and Management:
Analyze data for signal detection from various sources, including regulatory authority databases and literature.
Lead signal detection and evaluation activities, presenting findings and collaborating with the GSO team.
General Tasks:
Maintain knowledge of global regulatory reporting requirements and contribute to compliance activities.
Attend and participate in training sessions and audits as needed.
Mentor junior staff and assist with departmental process improvements.
Skills and Experience
Analytical and Problem-Solving Skills: Ability to analyze complex data and provide clear conclusions.
Strong Communication: Excellent verbal and written communication skills to convey complex scientific information.
Organizational Skills: Strong ability to prioritize tasks, manage multiple projects, and meet deadlines.
Collaboration: Ability to work effectively within a team and with cross-functional teams.
Client-Focused: Ability to address client needs and maintain strong relationships.
Technical Skills: Proficiency in MS Office (Word, Excel, PowerPoint) and experience with web-based applications.
Education and Qualifications
Degree: A minimum of a university degree in life sciences, health, or biomedical sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, etc.).
Additional Qualifications: A degree in Medicine, Dentistry, Nursing, or Experimental Medicine is preferred.
Experience: Relevant experience in regulatory affairs, pharmacovigilance, or medical writing is desirable.
About Parexel
Parexel is a global leader in the development and commercialization of innovative medical treatments. Our Medical Writing team plays a crucial role in ensuring that clinical and regulatory documentation meets the highest standards and complies with global regulatory requirements. Join us to help shape the future of healthcare and improve patient outcomes worldwide.
This position offers a rewarding opportunity for professionals with a passion for medical writing and regulatory affairs to contribute to groundbreaking clinical research while developing their careers in a dynamic and supportive environment.
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