Medical writer II

Description

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

General

Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations

Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting

Qualifications

Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.

Good knowledge of medical terminologies

Education: Science/Medicine degree: The minimum qualification required would be a university degree in life

Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology,

Biophysics etc.)

A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves

patient exposure in hospital-based environment, would be an advantage