MEDICAL WRITER

• Authoring of Pharmacovigilance safety reports for the client projects, including Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), Risk Management Plan (RMP), Addendum for Clinical Overview (ACO) etc.
• Author and prepare clinical documents associated with submissions to Regulatory authorities including but not limited to: model informed consents, interim and final clinical study reports, and safety update reports.
• Write procedural documents for the company i.e Standard Operating Procedures (SOPs), Working Instructions, Policies and Guidelines.
• Request source data required for preparing and writing the Pharmacovigilance and Regulatory documents from client.
• Reconcile the data received for the each report to ensure the data is correct.
• Conduct detailed analysis of the data/source information for the report.
• Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing.
• Preparation of the reports based on the requirement of the specific template (PBRER, PSUR, RMP etc).
• Provide medical editing/review of draft and final documents prepared by other writers before internal or external distribution.
• Serve as the Medical Writing representative on assigned project teams, providing proactive support for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
• Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Company SOPs including: distribute drafts, chair review meeting, incorporate revisions, document key project events, and complete sign-off procedures.
• Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution to the client.
• Line management of Medical Writing staff as required.
• Act as project lead
• Preparation of response for Adhoc Health Authority requests for client projects
• Attend internal and client project meetings.
• Supervise collection of materials by the Medical Writing Assistant or Associate Medical Writer for assembly of client deliverables.
• Keep abreast of professional information and technology and regulations and ensure the appropriate transfer of that information to the department.

Essential Qualification and Experience:

• At least 2 years of working experience in the pharmaceutical industry in pharmacovigilance department or CRO with experience in writing aggregate reports (PSURs and PADERs)
• Advanced academic degree in biological or natural science or health-care discipline e.g. MSc, PhD or MBBS/MD
• Previous experience within the pharmaceutical industry and at least 2 years of post-marketing safety data analysis preferred
• Familiarity with industry principles of drug safety, drug development, pharmacology, biostatistics, and pharmaco-epidemiology.
• Basic knowledge of data analytics and common data processing software.
• Excellent verbal and written communication skills and good command of English.
• Ability to interpret, analyse and clearly present scientific and technical data in verbal and written format.
• Functional knowledge of EXCEL, PowerPoint, Microsoft Word.
• Team player, ability to work under tight timelines with poise. Ability to manage high workload and critical issues.

How To Apply:

• Send your covering letter and CV to careers@symogen.com