10
March 19, 2025
Job Description
Job Type:
Full Time
Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences
Skills:
Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding
About This Role:
As a Medical Writer at Parexel, you will leverage your scientific expertise and writing proficiency to communicate complex scientific data effectively to stakeholders, including regulatory agencies, healthcare professionals, and the general public. You will collaborate with cross-functional teams to develop a variety of clinical research documents such as informed consent forms, clinical study reports, pharmacovigilance reports, and more. We value inclusivity and support a culture that fosters growth and continuous learning, offering opportunities for mentorship, job shadowing, and leadership development.
Key Responsibilities:
Aggregate Reports:
- Manage the preparation and update of Periodic Safety Reports (PSRs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Risk Management Plans (RMPs), and related documents.
- Perform critical appraisal and systematic review of literature, particularly epidemiology data, for inclusion in drug safety reports.
- Generate line listings, identify discrepancies, and resolve issues to ensure consistency and quality.
- Conduct aggregate report compliance activities, reviewing internal consistency across various types of safety reports.
- Distribute final reports to stakeholders and ensure timely submissions in compliance with regulatory requirements.
Clinical Study Report Narratives:
- Prepare clear, accurate narratives based on clinical database and safety database outputs, ensuring medical coherence in accordance with client and Parexel conventions.
- Perform quality checks on drafted narratives and assist in formatting and compiling deliverables.
Signal Detection & Management:
- Perform qualitative and quantitative signal detection reviews from various data sources, including regulatory authority databases and literature.
- Lead signal management activities in collaboration with safety science teams, ensuring timely and accurate reporting.
General Responsibilities:
- Maintain up-to-date knowledge of the adverse event safety profile of assigned drugs and regulatory obligations.
- Participate in training, audits, and inspections to maintain high standards of quality.
- Delegate work to associate medical writers and mentor new recruits when needed.
- Act as the primary client contact, ensuring high-quality delivery of work and addressing reviewer comments promptly.
- Archive source documents and relevant communications according to organizational requirements.
Skills & Qualifications:
- Analytical & Problem-Solving Skills: Ability to evaluate data, draw conclusions independently, and address challenges effectively.
- Excellent Communication Skills: Strong verbal and written communication skills, with an emphasis on clarity and precision.
- Team Collaboration: Ability to work collaboratively in a team environment, prioritizing tasks and working efficiently across functions.
- Organizational Skills: Strong organizational and prioritization abilities, with a detail-oriented and deadline-driven approach.
- Medical Writing Proficiency: Experience writing unambiguous medical content and summarizing complex data.
- Fluency in English: Excellent proficiency in written and spoken English.
- Technical Competency: Familiarity with web-based applications, MS Office suite (Word/Excel/PowerPoint), and general IT skills.
Knowledge & Experience:
- Regulatory/Pharmacovigilance Knowledge: Relevant experience in regulatory, pharmacovigilance, or related fields is desirable.
- Medical Terminology: Good understanding of medical terminology is essential.
- Educational Background: A university degree in life sciences, health, biomedical sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, etc.), or a degree in medicine/dentistry/experimental medicine would be advantageous.
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