job title:medical writer 2(parexel)

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), 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.

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

Key Accountabilities:

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 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 inliterature 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, 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

Clinical Study Report Narratives

• 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

Signal Detection and Management

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

• Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO

• Conduct/support signal detection and evaluation activities according to SOPs and guidelines