Expert Medical Regulatory Writer
Job Details
Full Job Description
Main responsibilities: Write and/or edit under guidance
high-quality clinical and safety documents for submission to
regulatory authorities to support marketing authorization
applications, renewals, and maintenance activities including complex
Clinical Study Reports (CSR), complex CTD submission documents
(clinical overview ( CO ) , summary of
clinical efficacy ( SCE ) , clinical
safety ( SCS ) , clinical pharmacology
( SCP ) , and biopharmaceutics (
SBP ) ), medical section of Periodic Benefit-Risk
Evaluation Report ( PBRER ) ,
medical sections of addendum to clinical overview
( ACO ) , Risk Management Plans (RMP),
Product and Disease ID Cards, clinical evaluation
report, Briefing packages, responses to Health Authorities Queries,
and immunogenicity 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 acting as an
SME on clinical deliverables , buddy or
mentor to the medical and senior medical writers
, efficiently peer reviews providing Scientific
inputs .
Essential Job duties and
responsibilities: 1) Leading complex submissions, contributing
to key messaging meetings, providing expert content
guidance for medical sections of CTD, and delivery of high-quality
medical documents in time and in compliance with internal standards
and external guidelines . 2) Participate in
the planning of analysis and data presentation to be
used as an ad-hoc member of the Clinical Trial Team (CTT), a
core member of the Clinical Submission Teams (CST) ,
and an extended member of the Global Clinical
teams (GCT) and Safety management team (SMT) . 3)
Develops and maintains TA expertise
and provides document-related advocacy to
other line functions . 4) Reviews content created by
peer writers and act as a coach, mentor, and trainer
for the development of writers for the new document
type . 5) Work with minimal supervision and support
development of medical regulatory writers . 6) Agile
and knowledgeable to be able to work across therapeutic areas.
Collaborates effectively with Scientific communication global or local
teams, Medical regulatory writing global or local teams,
Pharmacovigilance teams, CTT, CST, GCT, and SMT .
- People: 1) 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. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise
- Performance: 1) Provide deliverables (CSR, CO, SCE, SCS, SCP, SBP, PBRER, ACO, RMP, ID Cards, clinical evaluation report, Briefing packages, HAQs, Immunogenicity reports) as per agreed timelines and quality 2) Fair understanding of Product Alerts, and trial transparency documents with the agility to learn and contribute to situations of demands
- Process: 1) Acts as an expert in the field of medical regulatory writing and maintains the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis . 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region . 4) Work with selected vendors within the region to deliver the required deliverables per the defined process . 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery 6) Substantial understanding of Product Alert Process and Trial Transparency documents with the ability to quickly develop expertise and contribute swiftly if the situation demands
- Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables . 2) Liaise with th e Medical department to prepare relevant & customized deliverables . 3) Collaborate with CTT, CST, GCT and SMT . 4) Proactively l iaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables.
About you
Experience: 8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry- Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment , leading project teams
- Technical skills: As applicable (including but not limited to therapeutic area/domain knowledge exposure; publication submission; and/or project management ; Expert knowledge of and demonstrated accomplishment in global registration of drugs )
- Education: Advanced degree in life sciences/ pharmacy/ similar discipline ( PhD , Masters, or bachelor’s in science , D Pharm a , Pharm D ) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
- Languages: Excellent knowledge of the English language ( to read, write and speak )
Expert Medical Regulatory Writer
Sanofi
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