Associate Medical Writer – Parexel – Chandigarh, Chandigarh

Parexel’s Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas.

• Full Time
• Travel: No
• Glassdoor Reviews and Company Rating

Check out the top traits we’re looking for and see if you have the right mix.

• We are one truly global team working together to propel each client´s journey ahead faster.

• We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

• Opportunity to learn and grow through a performance and development goal-setting program.

• Love where you work, and work where you love.

• Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

• Preparing PSRs including Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Pharmacovigilance (PV) contributions to Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Reports (PADERs), Addendum to Clinical Overviews (ACOs), Corporate Addendum Reports, Safety Statements and Semi-Annual Safety Reports (SASRs) and checking of International Non-proprietary Names (INNs) for inclusion in a PSR in accordance with client requirements/conventions and Standard Operating Procedures (SOPs)
• Performing quality check of PSRs as per client requirements
• Maintaining excellent knowledge of the safety profile of the assigned products, client’s procedures and international drug safety regulations
• Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with timelines communicated by the client
• Interacting with internal or external contacts to resolve issues related to the processing of PSRs
• Sending queries to and liaising with the relevant client personnel regarding discrepancies, for obtaining incomplete/missing information with a view to resolve and clarify issues and facilitate processing of the reports

• Science/Medicine degree: The minimum qualification required would be a Masters degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
• Good knowledge of medical terminology
• Fluency in written and spoken English
• Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite (MS Word/Excel/PowerPoint)
• Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
• Ability to evaluate data and draw conclusions independently
• Typing and transcription accuracy