ProductLife Group is looking for a Senior Medical Writer to join its dynamic team to contribute to the activities performed in the Hub:
Role and Responsibilities:
Analysis of data and preparation of ad hoc reports/plans in the framework:
• PADER
• Risk management plan
• Benefit / risk evaluation report
• Signal detection and reporting
• PSUR / PBRER / Addendum to Clinical Overview
• DSUR
• Off label use reports (French requirements)
• PSUSA response
• Literature screening for medical writing reports
• Ad hoc reports from regulatory authority
Review of Medical Writing Reports:
• PADER
• Benefit / risk evaluation report
• Signal report – Simple Complexity
• Off label use reports
• Literature screening for medical writing reports or for level 2 medical information upon clients request
-Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical analysis
-Production and validation of safety reports (written by this division or by the Case Management Business Unit) depending on seniority and after successful experience in writing
-Medical training for staff from other divisions
-Participation in the drafting of quality documents related to the Medical writing specific activities (i.e., Standard Operating procedures (SOPs) and Working Practice Documents)
-Ensure adherence to GVP (French and European), ICH guidelines, other applicable guidelines, SOPs, and client templates.
-Understands and interprets clinical and scientific reports to allow the accurate capture of safety and efficacy data. Interprets and presents scientific data, analyses and appraise clinical, biomedical and scientific reports in a systematic, accurate, fair and balanced way.
-Analyses clinical evidence of all kinds (public, proprietary, published or unpublished, etc.) from all sources (journals, internal documents, regulatory submissions, etc. ) in order to assist customers, colleagues and management.
-Understands levels of evidence required to achieve regulatory and goals.
-Selection and Analysis of literature data based on the results of literature searches performed by the ad hoc division in order to write reports based on literature searches.
-Provides timely, accurate, appropriate and clear verbal and written information in response to enquiries about PLG customers’ products or therapy areas in order to facilitate the appropriate, effective, safe and continued use of company products.
-Prepares planning for aggregate reports for clients and shares it with QPPV / client as applicable.
-Responsible for client coordination & participation in audit & inspection to represent medical writing function.
-Supports in CAPA proposal & implementation. Prepares & review client technical agreement. —-Supports in effort estimation for new RFP & participate in Bid defense meeting.
QUALITY/SYSTEM MANAGEMENT
-Supports the Senior Medical Writer and the Service Area manager/ director/team leader in reviews metrics to assess accuracy, quality and regulatory compliance.
-Participates in training as required for ProductLife Group.
-Complies with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.
EDUCATION
-Pharmacist or physician residing and operating in France
PROFESSIONAL EXPERIENCE
-Minimum 5-8 years of experience in a PV department (preferentially in a Medical Writing department).
-Well versed with Safety databases
SOFT SKILLS
Team spirit
Client oriented
Analytical skills
Ability to summaries
Oral & writing skills
Critical analysis
Sense of meeting deadline
Great presentation skills
Service provider mindset