Medical Regulatory Writer Job at Sanofi For Life Sciences, Apply Online
Medical Regulatory Writer Job at Sanofi For Life Sciences, Apply Online. MSc, PhD job at Sanofi. Interested and eligible applicants can check out all of the details on the same below
Hey guys for those of you who are interested in applying for a Senior Medical Regulatory Writer job opportunity at Sanofi, then check out all of the possible interview questions listed below.
Job Title – Senior Medical Regulatory Writer
Job ID – R2680307
Location – Hyderabad
About the job
Write and/or edit high-quality clinical and safety documents, medical sections of Periodic Benefit-Risk Evaluation Reports, Addendum to clinical overviews, Clinical Study Reports (CSR), ID Cards, and evaluation reports, with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards.
Essential Job duties and responsibilities:
- Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
- Develops and maintains TA expertise.
- Reviews content created by peers’ writers.
- Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, and Pharmacovigilance teams.
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 and pharmacovigilance departments.
- Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.
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
Process:
- Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.
- Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
- Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.
- Work with selected vendors within the region to deliver the required deliverables as per the defined process.
- Design an overall plan of action basis end-customers feedback & improve course content and delivery.
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.
- Experience: >5 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
- Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills)
- Education: Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree (Ph.D. – master’s in science)
- Languages: Excellent knowledge of the English language (spoken and written)
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.
Hey guys for those of you who are interested in applying for a Senior Medical Regulatory Writer job opportunity at Sanofi, then check out all of the possible interview questions listed below.
- Can you describe your experience in medical regulatory writing for the pharmaceutical/healthcare industry? How do you ensure the quality and compliance of your documents? Answer: I have over 5 years of experience in medical regulatory writing, working on various documents such as Clinical Study Reports (CSR), Periodic Benefit-Risk Evaluation Reports (PBRER), and Investigator brochures. To ensure quality and compliance, I adhere to internal and external standards, collaborate with peer writers for content reviews, and maintain expertise in regulatory requirements for different countries.
- How do you approach planning and data analysis for the preparation of clinical and safety documents? Do you work independently or seek guidance from mentoring medical writers? Answer: I believe in a collaborative approach. Initially, I work with mentoring medical writers to plan the analysis and data presentation. However, as I develop my expertise, I can participate independently in the planning process. Collaboration with cross-functional teams ensures accuracy and completeness in the documents.
- As a Senior Medical Regulatory Writer, how do you stay up-to-date with changes in the regulatory landscape and maintain therapeutic area expertise? Answer: Staying updated with the regulatory landscape is crucial. I actively engage in continuous learning, attend relevant workshops and conferences, and keep a close eye on industry publications. By constantly building my knowledge base, I can maintain therapeutic area expertise and effectively address any regulatory challenges.
- How do you handle stakeholder management and communication in your role? Can you provide an example of a successful collaboration with scientific communication and pharmacovigilance teams? Answer: Effective stakeholder management is essential in my role. I establish strong relationships with stakeholders in medical and pharmacovigilance departments to ensure smooth collaboration. For instance, when working on a complex safety document, I collaborated closely with scientific communication and pharmacovigilance teams to ensure accurate data representation and seamless information flow.
- In your experience, how do you approach developing medical regulatory writing skills in junior team members? How do you share expertise and knowledge effectively? Answer: Mentoring and knowledge sharing are crucial aspects of my role. I assist junior team members in developing their writing skills by providing guidance and constructive feedback. Additionally, I organize workshops and training sessions to share expertise and best practices, fostering a culture of continuous learning within the team.
(Note: The answers provided are sample responses and can be tailored based on the candidate’s actual experience and achievements in medical regulatory writing.)
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