As a Medical Writer at Parexel, you will use your scientific knowledge and writing skills to effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the public. Collaborating within cross-functional teams, you will develop a wide range of clinical research documents, such as informed consent forms, clinical study reports, pharmacovigilance documents, and more.
Responsibilities:
- Aggregate Reports Management:
- Prepare/update/merge Risk Management Plans (RMPs), Company Core-RMPs (CC-RMPs), and other safety reports in accordance with client requirements and SOPs.
- Conduct critical appraisal and systematic review of literature for inclusion in safety reports and RMPs.
- Generate Line Listings for submissions, identify discrepancies, and ensure resolution.
- Perform compliance activities, quality checks, and distribute final reports to stakeholders.
- Clinical Study Report Narratives:
- Prepare clear and accurate narratives based on Clinical Database and Safety Database outputs.
- Perform quality checks and assist in formatting narrative deliverables.
- Signal Detection and Management:
- Perform signal detection review and analysis from various sources.
- Manage the end-to-end signal management process.
- General Responsibilities:
- Maintain knowledge of adverse event safety profiles, labeling documents, client’s guidelines, and international drug safety regulations.
- Organize workload to ensure compliance with internal and regulatory timelines.
- Participate in training sessions, audits, and inspections.
- Mentor new recruits and respond to client/customer inquiries in a timely manner.
Skills and Competencies:
- Strong analytical and problem-solving skills.
- Excellent interpersonal and communication skills.
- Ability to work collaboratively in a team environment.
- Strong organizational and prioritization skills.
- Client-focused approach with the ability to manage multiple tasks with attention to detail.
- Fluency in written and spoken English.
- Proficiency with computer applications, particularly MS Office.
Knowledge and Experience:
- Relevant experience in Regulatory/Pharmacovigilance or related field is desirable.
- Good knowledge of medical terminologies.