Medical Writer I

2 weeks ago

Remote, India Parexel Full time

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. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
- Travel: No
- Glassdoor Reviews and Company Rating

**Success Profile**:
Check out the top traits we’re looking for and see if you have the right mix.
- Detail-Oriented
- Deadline-Oriented
- Communicator
- Organized
- Versatile
- Tech-Savvy

**Rewards**:

- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Work-life Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Career Development**: Opportunity to learn and grow through a performance and development goal-setting program.
- **Home based**: Love where you work, and work where you love.
- **Variety**: Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

Job Purpose:
- 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),

**Job Description**:

- 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
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.
Ensuring that all work is complete and of high quality prior to team or client
distribution. Confirm data consistency and integrity across the document.
Performing aggregate report compliance activities including quality review
to check the data/facts and internal consistency across various type of
aggregate reports including but not limited to PBRERs, Ad hocs, HHEs,
LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF)
document (as applicable)
Distributing of final reports to the stakeholders including partners, affiliates
and submission to health authorities, according to the agreed timelines,
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
R

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