Sanofi
Senior Medical Regulatory Writer
Sanofi, Baltimore, Maryland, United States,
Senior Medical Regulatory Writer
Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews.Essential Job Duties and Responsibilities:
Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.Develops and maintains TA expertise.Reviews content created by peers’ writers.Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned.People:
Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement.Interact effectively with stakeholders in medical and pharmacovigilance departments.Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.Performance:
Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality.Process:
Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.Work with selected vendors within the region to deliver the required deliverables as per the defined process.Design an overall plan of action based on end-customers feedback & improve course content and delivery.Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts.Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness.Remain abreast of Sanofi Consumer Care Policy or Quality Documents evolution.Stakeholders:
Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Corporate Affairs departments to prepare relevant & customized deliverables.About You:
Experience:
>5 years of experience in regulatory writing for the pharmaceuticals/healthcare industrySoft Skills:
Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environmentTechnical Skills:
Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applicationsEducation:
Advanced degree in life sciences/pharmacy/similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD)Languages:
Excellent knowledge of the English language (to read, write, and speak)Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.Why Sanofi:
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews.Essential Job Duties and Responsibilities:
Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.Develops and maintains TA expertise.Reviews content created by peers’ writers.Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned.People:
Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement.Interact effectively with stakeholders in medical and pharmacovigilance departments.Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.Performance:
Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality.Process:
Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.Work with selected vendors within the region to deliver the required deliverables as per the defined process.Design an overall plan of action based on end-customers feedback & improve course content and delivery.Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts.Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness.Remain abreast of Sanofi Consumer Care Policy or Quality Documents evolution.Stakeholders:
Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Corporate Affairs departments to prepare relevant & customized deliverables.About You:
Experience:
>5 years of experience in regulatory writing for the pharmaceuticals/healthcare industrySoft Skills:
Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environmentTechnical Skills:
Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applicationsEducation:
Advanced degree in life sciences/pharmacy/similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD)Languages:
Excellent knowledge of the English language (to read, write, and speak)Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.Why Sanofi:
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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