Senior Medical Writer - Regulatory Writing - FSP

Job Summary

The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals.

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.

• Preparing/Updating/Merging RMPs/Company Core‑RMPs (CC‑RMPs), preparing 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 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), 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

• 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)

• Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies

• Distribution of final reports to the stakeholders including partners, affiliates and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required)

• Scheduling and coordinating meetings/ Drafting meeting agenda and minutes/Tracking action items and soliciting follow‑up for open issues

• Coordinates and liaises with the members of Study Management Team (SMT)/Study In‑charge or equivalent, to discuss the narrative template development process, narrative categories and review of the narratives (as required)

• Serves as primary client contact for narrative writing for an assigned study, agreeing/negotiating deliverable timelines, and addressing/resolving any narratives related issues (as required)

• Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client and ensures their appropriate medical cohesiveness and assessment in accordance with the client’s and Parexel’s conventions/guidelines and Standard Operating Procedures

• Performs quality checks on the drafted narratives as required

• Ensures the work is complete and of high quality, including final quality control checks, compilation and formatting.

• Provides CSR narrative review support to the SMT where requested

• Build and maintain collaborative relationships with SMTs for an efficient, productive, and professional working relationship (as applicable)

• Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literature, regulatory authority websites etc.

• Responsible for the end‑to‑end signal management…