Scientific Writer

Job description

Mission statements

·  Write and/or edit under guidance high quality clinical and safety documents, medical section of Periodic Benefit-Risk Evaluation Report, addendum to clinical overview, Clinical Study Reports (CSR), ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA..
·  Delivery of high-quality medical documents in time and in compliance with internal and external standards
·  Participate in planning of analysis and data presentation to be used, initially in conjunction with mentoring medical writer.
·  Develops and maintains TA expertise
·  Reviews content created by peers writers

Collaboration

·  Scientific communication global or local teams
·  Medical regulatory writing global or local teams
·  Pharmacovigilance teams

Duties & Responsibilities

Sl.

Work Area

Performance Indicators

1.

People

·  Maintain effectiveness 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 on medical and pharmacovigilance departments
·  Constantly assist other medical regulatory writers in developing knowledge and sharing expertise

·  Feedback from stakeholders (end customers, medical teams) on overall satisfaction

2.

Performance

·  Provide deliverables (PBRER, ACO, CSR, ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA  ) as per agreed timelines and quality
·  Adherence to timeline
·  Adherence to quality target

3.

Process

·  Act as an expert in the field of medical regulatory writing and maintain on regulatory requirement for countries supported.
·  Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis
·  Implement relevant element of medical regulatory plan and associated activities for the year identified for the region
·  Work with selected vendors when required within the region to deliver the required deliverables as per defined process
·  Design an overall plan of action basis end-customers feedback & improve course content and delivery

·  Feedback from stakeholders (end customers, medical teams) on satisfaction with services provided
·  Adherence to Plan / Calendar

4.

Customer

·  Work closely with Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables
·  Liaise with Medical department to prepare relevant & customized deliverables
·  Feedback from stakeholders (end customers, medical teams) on satisfaction with services provided

Knowledge, Skills & Competencies / Language

Therapy Area Exposure

·  Diabetes
·  Familial hypercholesterolemia
·  Cardiovascular disease
·  Multiple sclerosis,
·  Immunology
·  Oncology
·  Market access
·  Emerging markets
·  Generics
·  Vaccines
·  Vitamins and supplements
·  Digestive
·  Allergies
·  Parkinson
·  Haemophilia
·  Rare diseases
·  Rare blood diseases

Stakeholder management

Project management

Regulatory Procedures

Qualifications

·  Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree (Ph.D – Master in science)
·  Excellent English language knowledge

Requirements of the job

·  >5 years of experience in regulatory writing for the pharmaceuticals / healthcare industry
·  Experience in at least one of the Therapeutic area - Cardiovascular, metabolism, Diabetes and Lipid, CNS, Oncology, Anti-infectives, Internal medicine.

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.