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
- Level: Mid
- Travel: No
- Glassdoor Reviews and Company Rating
Check out the top traits we’re looking for and see if you have the right mix.
"I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,Christine, Medical Writer II
knowledgeable, and it is easy to communicate with other staff."
"Parexel makes it easy to communicate and interact with each other, which allowsKristy, Associate Manager
me access to expertise and knowledge beyond my own."
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.
• 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
• 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
• Attending meetings/ Drafting meeting agenda and minutes/Tracking action items
Note: The below statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable
Accountability Supporting Activities
Aggregate reports • Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs), preparing a health authority response document along with RMS update in accordance with client requirements/conventions and SOPs.
• Managing scheduled and unscheduled aggregate reports including but not limited to 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, Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs), comparison document 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 conventions and SOPs
• Conducting critical appraisal and systematic review of literature with a focus on background epidemiology, specifically information on the incidence, prevalence and risk factor in patient populations, for inclusion in drug Safety Reports and RMPs
• Providing input and developing literature search strategies for the epidemiology section of safety reports
• Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports
• Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies
• Revising document drafts based on the review comments from team members to ensure inclusion of all relevant input.
• Analytical and problem-solving skills
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Excellent organizational and prioritization skills
• Ability to work collaboratively and effectively in a team environment
• Client focused approach to work
• Ability to evaluate data and draw conclusions independently
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Ability to understand all necessary steps in a project, plan steps ahead, and identify critical paths
Knowledge and Experience:
- Minimum 3 years of experience in Pharmacovigilance (aggregate report writing experience preferred)
- Good knowledge of medical terminologies
- M. Pharmacy
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