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Medical Writing Parexel Jobs – Life Sciences Apply Online
Company Name: Parexel
Location: Mohali, India
Category: Medical Writing
Job Purpose:
The Medical Writer I will be responsible for managing scheduled and unscheduled aggregate reports, including but not limited to Periodic Safety Reports (PSRs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Addendum to Clinical Overviews (ACOs). They will also be involved in signal detection and management, as well as preparing narratives for Clinical Study Reports (CSRs) and supporting health authority requests.
Key Accountabilities:
Aggregate Reports:
- Prepare, update, and merge RMPs/Company Core-RMPs (CC-RMPs) in accordance with client requirements and SOPs.
- Manage scheduled and unscheduled aggregate reports, ensuring adherence to client requirements and conventions.
- Conduct critical appraisal and systematic review of literature for inclusion in drug Safety Reports and RMPs.
- Generate line listings and identify discrepancies for resolution.
- Revise document drafts based on review comments and ensure data consistency and integrity.
- Perform quality reviews to check the data and internal consistency across various types of aggregate reports.
- Distribute final reports to stakeholders and submit to health authorities according to agreed timelines.
Clinical Study Report Narratives:
- Prepare clear and accurate narratives based on clinical and safety databases, ensuring medical cohesiveness and assessment.
- Perform quality checks on drafted narratives.
- Assist in compilation and formatting of the narrative deliverables.
Signal Detection and Management:
- Perform signal detection review and analysis from various sources.
- Lead the end-to-end signal management process in collaboration with the safety science team.
- Conduct signal detection and evaluation activities according to SOPs and guidelines.
General:
- Maintain a good working knowledge of adverse event safety profiles, labeling documents, client guidelines, procedures, and SOPs.
- Ensure compliance with internal and regulatory timelines for adverse event reporting.
- Keep up-to-date with assigned clinical studies for narratives.
- Attend training sessions, participate in audits and inspections, and strive to enhance client satisfaction.
- Delegate work as appropriate, mentor new recruits, and respond to clients/customers in a timely manner.
Skills:
- Analytical and problem-solving skills
- Excellent interpersonal and communication skills
- Strong organizational and prioritization skills
- Ability to work collaboratively in a team environment
- Client-focused approach to work
- Fluent in written and spoken English
- Computer proficiency, including knowledge of web-based applications and the Microsoft Office suite
- Typing and transcription accuracy
- Cultural awareness and ability to work in a matrix environment
Knowledge and Experience:
- Relevant experience in Regulatory/Pharmacovigilance or related field is desirable.
- Good knowledge of medical terminologies.
- University degree in Life Sciences/Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
- Degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing (with patient exposure in a hospital-based environment) is advantageous.
Keywords: Medical writer, medical writing role, life sciences, Parexel, Mohali, aggregate reports, Periodic Safety Reports (PSRs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), signal detection, Clinical Study Reports (CSRs), health authority requests, regulatory compliance, narratives, signal management, pharmacovigilance, medical terminologies. Medical Writing Parexel Jobs – Life Sciences Apply Online. Please ensure you are subscribed to the Getmicrobiologyjobs Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
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