Location: India (Remote)
Company: Parexel
About this Role:
As a Medical Writer at Parexel, you will leverage your strong scientific knowledge, writing skills, and patient focus to effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You will collaborate within cross-functional teams to develop a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.
Our Culture:
We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives. We offer continuous learning opportunities, from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.
Essential Soft Skills and Traits:
Job Purpose:
You will be responsible for managing 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) reports, Risk Management Plans (RMPs), Safety statements, Health Hazard Evaluations (HHEs), Drug Safety Reports (DSRs), Clinical Overviews (COs), Safety Evaluation Reports (SERs), and Investigational New Drug Annual Reports (INDARs). You will also prepare documents comparing local and global labeling documents and checking International Non-proprietary names (INNs) for inclusion in PSRs as per client requirements.
Key Accountabilities:
Aggregate Reports:
Clinical Study Report Narratives:
Signal Detection and Management:
General:
Apply Now: Please visit Parexel Careers for more information and to submit your application.
Link: https://jobs.parexel.com/en/job/remote/medical-writer-i/877/67563645616
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Mexico |Tennessee :
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Blacksburg | Charlottesville | Falls Church |Washington :
Pullman | Seattle |WI :
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Berlin |Hesse :
Marburg |Hessen :
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Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
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Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Zagreb |Republic of Egypt :
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Seoul |Capital of Netherland :
Amsterdam |Remote :
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Bangkok |