Principal Medical Regulatory Writer

Job title: Principal Medical Regulatory Writer

Location: Barcelona

% of travel expected: Travel required as per business need

Job type: Permanent and Full time

About the job

Our Team:

Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

Main responsibilities:

Independently write and/or edit/analyse/compile/summarize high-quality clinical and safety documents for timely submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities, in compliance with internal and external standards and guidelines, including complex Clinical Study Reports (CSR), complex CTD submission documents (Clinical Overview [CO], Summary of Clinical Efficacy [SCE], Summary of Clinical safety [SCS], Summary of Clinical Pharmacology [SCP], and Summary of Bio-Pharmaceutics [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; Develop and maintain various Therapeutic Areas (TAs), processes, and compliance expertise and help build/enhance the scientific ecosystem of medical writing teams under different TA(s); Acts as an Center of Excellence (CoE) leader by disseminating leading-edge knowledge/ best practices, process optimization, and competency in multiple deliverables across various TAs; Work towards integrated and effective communication with stakeholders, peers, and employees at all levels within the organization to increase efficiency; Manage end-to-end writing processes including documentation and approval in document management system for multiple parallel projects across TAs, with ability to resolve project related problems, or approving alterations in ongoing processes ; Effectively coach, guide and mentor medical writers within the team via structured, focused interactions, and using appropriate strategies, tools and techniques for their development.

Essential Job duties and responsibilities:

• 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
• 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)
• Develops and maintains TA expertise and provides document-related advocacy to other line functions
• Perform critical content reviews, correctly interpret results, identify potential limitations, and discuss unexpected findings, also acting as a coach, mentor, and trainer for the development of writers for the new document types
• Manage multiple projects simultaneously and support development of medical regulatory writers
• 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
• Stay up to date on regulatory expectations in regards document content for study and submission requirements and ensures team awareness of developments impacting medical writing standards
• Identify Medical Writing process improvement opportunities and contribute to development /maintenance of operating procedures
• Serve as back up to Head/Lead of Medical Writing at project meetings
• Manage end-to-end writing process including documentation and approval in Veeva Vault or other electronic document management system of multiples parallel projects across Therapeutic Areas
• Define and implement stakeholder engagement strategies and tactics and partner to provide strategic inputs to the development of various clinical deliverables
• Coach and review documents content created by other writers in the team with direct or indirect people management responsibilities
• 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, clinical, regulatory, labelling and pharmacovigilance departments
• Constantly assist other medical regulatory writers in developing knowledge and sharing expertise
• Partner with Head/TL to strengthen capabilities and support individual development plans
• Provide proactive recommendations on improving a deliverable and play an active role to follow the best practices in relation to processes, communications, project management, documentation, and technical requirements
• Serve as back up to Head/Lead of Medical Writing at project meetings
• Performance:
• Provide deliverables (study outline, protocol, CSR, ICF, CO, SCE, SCS, SCP, SBP, PBRER, DSUR, ACO, RMP, ID Cards, clinical evaluation report, Briefing packages, HAQs, Immunogenicity reports) as per agreed timelines and quality
• Fair understanding of Product Alerts, and trial transparency documents with the agility to learn and contribute to situations of demands
• Provide strategic support to stakeholders
• Be a subject matter expert, coach, mentor, and assist fellow medical writers for the new document type
• Perform critical content reviews, correctly interpret results, identify potential limitations, and discuss unexpected findings
• Stay up to date on regulatory expectations in regards document content for study and submission requirements and ensure team awareness of developments impacting medical writing standards
• Supports the Head/TL for talent management and succession plans
• Process:
• Develops complex medical writing documents.
• Acts as an expert in the field of medical regulatory writing and maintains the regulatory requirement for the assigned therapeutic areas and the countries supported
• Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis
• Create the timelines for the assigned tasks and implement relevant elements of the medical regulatory plan for the submission and associated activities
• Work with selected vendors to deliver the required deliverables per the defined process, such as narratives
• Leverage advanced training delivery tools and techniques thereby enhancing the effectiveness of training delivery
• Design an overall plan of action basis end-customers feedback and improve the writing aspects, trainings course content and delivery
• Substantial understanding of Product Alert Process and Trial Transparency documents with the ability to quickly develop expertise and contribute swiftly if the situation demands
• Understand budget estimates and support Head/TL with budget discussions and resource allocation
• Stakeholders:
• Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables
• Liaise with the Medical department to prepare relevant & customized deliverables
• Collaborate with Clinical Trial Team, Clinical Study Team, Global Clinical Team, and Study Management Teams
• Proactively liaise with the Clinical/Medical/ Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables

About you

• Experience: ≥12 years of experience in medical regulatory writing for the pharmaceuticals/ healthcare industry, experience in trainings, mentoring, team management and leadership roles are desirable
• Soft skills: Stakeholder management; communication skills; and work independently and within a team environment, leading project teams
• Technical skills: As applicable (including but not limited to therapeutic area/domain knowledge exposure; regulatory publishing, submission readiness; 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 Pharma, Pharm D) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
• Languages: Excellent knowledge of the English language (to read, write and speak)

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