Expert Medical Regulatory Writer
Year Hyderabad, Telangana, India
Job Description
b'
Job summary
- 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), addendum to clinical overview (ACO), Risk Management Plans (RMP), ID Cards, clinical evaluation report, Briefing packages, responses to Health Authorities Queries, and immunogenicity reports.
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
- 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
- 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
Knowledge, Skills & Competencies / Language
- Therapeutic area/domain knowledge exposure (including but not limited to): Diabetes, Familial hypercholesterolemia, Cardiovascular disease, Multiple sclerosis, Immunology, Oncology, Market access, Emerging markets, Generics, Vaccines, Vitamins and supplements, Digestive, Allergies, Parkinson, Haemophilia, Rare diseases, and rare blood diseases
- Stakeholder management
- Project management
- Regulatory Procedures
Qualifications
- Advanced degree in life sciences/ pharmacy/ similar discipline (Phd, Masters, or bachelor\xe2\x80\x99s in science, D Pharms) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
- Excellent English language knowledge (Spoken and Written)
Any other requirements of the job
- 8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
- Expert knowledge of and demonstrated accomplishment in global registration of drugs
- Excellent communication skills (written, verbal, and presentation)
- Substantial knowledge of biostatistics principles
- Experience in managing global, cross-functional teams and working in a Matrix environment
- Demonstrated ability to motivate, coach or mentor people.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Beware of fraud agents! do not pay money to get a job
MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.
Related Jobs
Job Detail
-
Job IdJD3053124
-
IndustryNot mentioned
-
Total Positions1
-
Job Type:Full Time
-
Salary:Not mentioned
-
Employment StatusPermanent
-
Job LocationHyderabad, Telangana, India
-
EducationNot mentioned
-
ExperienceYear