Work Opportunity as a Medical Writer I at Parexel – Apply Now

Embark on a transformative career journey with Parexel! Your gateway to exciting career opportunities begins here as we invite talented individuals to join our team as Medical Writer I in the vibrant city of Mohali, India. At Parexel, we are at the forefront of advancing clinical research, prioritizing patient safety, and actively shaping the landscape of life-changing therapies.

As a Medical Writer I, you will play a crucial role in translating complex scientific information into clear, concise, and compelling documents. This position offers a unique blend of scientific expertise and communication skills, making it an ideal opportunity for those passionate about contributing to groundbreaking advancements in healthcare.

Key Accountabilities:
Aggregate Reports:
1. 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.
2. Managing scheduled and unscheduled aggregate reports, including but not limited to PSURs, PBRERs, ACOs, SASRs, PADERs, DSURs, ARBE report, Safety statements, HHE, DSR, CO, SER, INDARs, comparison document between local and global labeling document, and checking of INNs for inclusion in a PSR as per client requirements and conventions.
3. Conducting critical appraisal and systematic review of literature, focusing on background epidemiology for inclusion in drug Safety Reports and RMPs.
4. Providing input and developing literature search strategies for the epidemiology section of safety reports.
5. Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports.
6. Generating Line Listings for submissions and identifying discrepancies for resolution.

Clinical Study Report Narratives:
1. Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client.
2. Ensures appropriate medical cohesiveness and assessment in accordance with client’s and Parexel’s conventions/guidelines and Standard Operating Procedures.
3. Performs quality checks on drafted narratives as required.
4. Assists in compilation and formatting of narrative deliverables.

Signal Detection and Management:
1. Performs signal detection review and analysis (qualitative and quantitative) from various sources.
2. Responsible for end-to-end signal management process in collaboration with the safety science.
3. Conducts/supports signal detection and evaluation activities according to SOPs and guidelines.

General:
1. Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures, SOPs, and international drug safety regulations.
2. Ensuring all work is complete and of high quality.
3. Attending internal, drug safety, and project-specific training sessions.
4. Preparation for, participation in, and follow-up on audits and inspections.
5. Maintaining an awareness of global regulatory reporting obligations.
5. Organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
6. Delegating work as appropriate to Associate Medical Writer.
7. Striving to enhance client satisfaction based on feedback.
8. Serving as the primary client contact, liaising and collaborating with the relevant function at the client’s end.
9. Evaluating and incorporating reviewer comments in draft reports.
10. Mentoring new recruits in the team if required.
11. Archiving source documents and relevant emails as required.
12. Responding to clients/customers in a timely manner.

Skills:
1. Analytical and problem-solving skills.
2. Excellent interpersonal, verbal, and written communication skills.
3. Excellent organizational and prioritization skills.
4. Ability to work collaboratively and effectively in a team environment.
5. Client-focused approach to work.
6. Ability to evaluate data independently and draw conclusions.
7. Flexible attitude with respect to work assignments and new learning.
8. Ability to manage multiple tasks with enthusiasm and prioritize workload with attention to detail.
9. Fluent in written and spoken English.
10. Computer proficiency, IT skills, and familiarity with web-based applications and the MS Office suite.

Company: Parexel
Location: India-Mohali
Time Type: Full-time
Job Requisition ID: R0000017796

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