Remote Medical Writing Opportunity at Parexel – Apply Now!

Remote Medical Writing Jobs at Parexel – Apply Now!

Remote Medical Writing at Parexel

Medical Writer I

Location: Remote, India

Job ID: R0000028944

Category: Medical Writing

Date Posted: 12/04/2024

About This Role

Job Purpose:

Responsible for:

• Management of scheduled and unscheduled aggregate reports including but not limited to:
  • Periodic Safety Reports (PSRs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Addendum to Clinical Overviews (ACOs)
  • Semi-Annual Safety Reports (SASRs)
  • Corporate Addendum Reports
  • United States Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Risk-Benefit Evaluation (ARBE) report
  • Risk Management Plan (RMP)
  • Safety Statements
  • Health Hazard Evaluation (HHE)
  • Drug Safety Report (DSR)
  • Clinical Overview (CO)
  • Safety Evaluation Report (SER)
  • Investigational New Drug Annual Report (INDARs)
  • Comparison documents between local and global labeling documents (if applicable)
  • Checking International Non-proprietary Names (INNs) for PSRs per client requirements
• Generating line listings, creating drug lists/folders, performing regulatory submissions, testing electronic submission gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions
• Preparing narratives for clinical trials to support health authority requests as per regulatory/client requirements
• Scheduling and attending meetings, drafting agendas and minutes, and tracking action items

Key Accountabilities

• Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs) and health authority response documents
• Conducting literature reviews for epidemiological data for safety reports
• Generating line listings for submissions, identifying discrepancies, and ensuring resolution
• Revising drafts based on team feedback to ensure high-quality deliverables
• Performing quality reviews to ensure consistency across reports
• Distributing final reports to stakeholders within agreed timelines
• Scheduling and attending meetings, drafting agendas, and tracking action items

Clinical Study Report Narratives

• Drafting clear and accurate narratives based on clinical and safety database outputs
• Performing quality checks and assisting in narrative compilation and formatting

Signal Detection and Management

• Conducting qualitative and quantitative signal detection from various sources
• Managing end-to-end signal processes, including tracking, assessment, and reviews

General Responsibilities

• Maintaining awareness of adverse event safety profiles, regulatory reporting obligations, and client guidelines
• Ensuring compliance with internal and regulatory timelines
• Participating in training, audits, and inspections
• Mentoring new recruits and delegating work as appropriate
• Responding to client queries promptly
• Enhancing client satisfaction based on feedback

Skills

• Analytical and problem-solving skills
• Excellent interpersonal, communication, and organizational skills
• Ability to evaluate data, work collaboratively, and manage multiple tasks effectively
• Proficiency with IT tools and MS Office suite

Knowledge and Experience

• Relevant experience in regulatory/pharmacovigilance is desirable
• Good knowledge of medical terminologies

Education

• University degree in life sciences/health or biomedical sciences (e.g., pharmacy, microbiology, biotechnology)
• Advantage: Degree in medicine, dentistry, physiotherapy, or nursing with hospital-based exposure

#LI-REMOTE

Link to apply: APPLY ONLINE HERE

Keywords: Remote Medical Writing, Medical Writer Job, Medical Writing Role, Life Sciences Industry, Healthcare Landscape, Analytical Skills, Pharmacovigilance Experience, Health Authority Compliance, Science Degree, Biomedical Sciences, Client-focused Approach. Remote Medical Writing Jobs at Parexel – Apply Now! Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.