Parexel Hiring Associate Medical Writer

Parexel is a global leader dedicated to improving the world’s health through cutting-edge clinical development solutions. From clinical trials to regulatory, consulting, and market access, Parexel is driven by a shared goal – a deep conviction in improving patient outcomes. Join us in making a difference and contributing to the development of therapies that positively impact lives.

Position Title: Associate Medical Writer

Company Name: Parexel

Salary: Competitive, based on experience

Company Address: India-Chandigarh-Remote

Time Type: Full Time

Job Requisition ID: R0000017552

Detailed Job Description

Role: Associate Medical Writer

Under departmental supervision, you will be responsible for the management of scheduled and unscheduled aggregate reports, including but not limited to:

• Responsible for preparing the narratives associated with the client’s/sponsor’s products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and client’s/sponsor’s requirements
• Under departmental supervision,
• responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including 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) as well as preparing document of comparison between local and global labeling document  (if applicable)and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable).
• Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions.

APPLY ONLINE