Medical Writer Job at Sanofi in Spain | Regulatory Writer Role for Medical Candidates
The medical writer job opportunity with Sanofi offers experienced professionals a chance to contribute to global regulatory submissions and scientific documentation. Based in Barcelona, this role focuses on preparing high-quality clinical and regulatory documents while collaborating with global medical and pharmacovigilance teams. Professionals with backgrounds in MBBS job, MD Job, or BDS Job profiles looking for medical jobs in Spain can explore this exciting opportunity in the pharmaceutical industry.
Job Details:
- Job Title: Expert Medical Regulatory Writer
- Location: Barcelona, Spain
- Job Type: Permanent and Full Time
About the Company:
Sanofi is a global healthcare company dedicated to improving lives through innovative medicines and vaccines. The organization focuses on advancing healthcare across multiple therapeutic areas while supporting global medical, regulatory, and research teams. Sanofi Business Operations serves as an internal resource organization designed to centralize processes and activities that support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. This structure enables strong collaboration and strategic support for global healthcare initiatives and regulatory documentation.
Job Description:
This medical writer job focuses on preparing and editing high-quality clinical and safety documents for regulatory submissions. The role involves developing complex clinical study reports, regulatory submission documents, and safety reports for health authorities. Professionals with experience in MBBS job, MD Job, or BDS Job backgrounds may find this opportunity valuable while exploring medical jobs in Spain in the pharmaceutical and regulatory writing domain.
Qualifications:
- Education: Medical degree (MBBS, BDS, MD)
- 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: Expert knowledge of and demonstrated accomplishment in global registration of drugs
- Languages: Excellent knowledge of the English language (to read, write, and speak)
Key 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.
- 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 therapeutic area expertise and provides document-related advocacy to other line functions.
- Reviews content created by peer writers and act as a coach, mentor, and trainer for the development of writers for the new document type.
- Work with minimal supervision and support development of medical regulatory writers while collaborating 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.
