Medical Information Writer Job for Life Sciences Candidates at Sanofi
Medical Information Writer Job for Life Sciences Candidates at Sanofi. Senior Medical Information Writer Job for MSc & Ph.D life sciences Candidates at Sanofi. Interested Candidates can check out the details below and Apply Online
Job title: Senior Medical Information Writer
Job Location: Hyderabad & Mumbai, India
Job id: R2699591
Job Type: Full Time
Main responsibilities:
Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Responsible for the execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, and document management proficiency.
Essential Job duties and responsibilities:
1) Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature.
2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s).
3) Adapts global scientific response documents for assigned countries.
4) Develops responses to escalated inquiries for assigned countries.
5) Develops contributions to US NDA Annual Reports.
6) Contributes to US compendia reviews.
7) Contributes to peer
reviews.8) Demonstrates resolve and urgency to accomplish tasks without direct authority or control. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule.
9) Develops and maintains Therapeutic Area expertise.
10) Reviews the content created by peer writers.
11) Collaborates effectively with Global Medical Information teams to execute content plans
- People: 1) 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 information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise.
- Performance: Provide deliverables (scientific response documents, US NDA Annual Reports, US compendia reviews) as per agreed timelines and quality
- Process: 1) Act as an expert in the field of medical information writing and maintain on the regulatory requirement for countries supported. 2) Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery.
- Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables.
Requirements :
Experience: >5 years of experience in medical writing for the pharmaceuticals/ healthcare industry or equivalent experience in a clinical setting; At least 2-3 years of direct medical information experience in a pharmaceutical company
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, Knowledge about literature evaluation and multilevel response development)
Education: Advanced degree in life sciences/ pharmacy/ similar discipline, or medical degree or doctorate degree (PharmD, Ph.D, Master in science, MBA or equivalent)
Languages: Excellent knowledge of the English language (spoken and written)
Here are five Possible interview questions along with possible answers :
1. Question: Can you describe your experience in medical writing, particularly in the pharmaceutical or healthcare industry, and how it aligns with the responsibilities of a Senior Medical Information Writer?
Answer: I have over 5 years of experience in medical writing, including more than 2-3 years in direct medical information roles within the pharmaceutical industry. During this time, I’ve authored scientific response documents, conducted literature reviews, and generated evidence-based summaries of complex data from scientific literature. My experience has equipped me with the skills required to fulfill the responsibilities of a Senior Medical Information Writer.
2. Question: The job description mentions conducting literature searches and extracting complex data. Can you provide an example of a challenging literature review you’ve conducted and how you handled it?
Answer: Certainly. In a previous role, I was tasked with conducting a literature review for a product in a highly specialized therapeutic area. The challenge was the limited availability of relevant literature. I addressed this by collaborating with subject matter experts, expanding the search criteria, and meticulously summarizing the available data. This ensured we had a comprehensive understanding of the topic, despite the initial limitations.
3. Question: How do you ensure that the scientific response documents you create are accurate, current, and fair-balanced, especially when dealing with complex scientific data?
Answer: Accuracy, currency, and fairness are paramount in medical writing. I maintain a rigorous approach by continuously monitoring the scientific literature for updates, cross-referencing information, and involving subject matter experts for validation. Additionally, I adhere to regulatory guidelines and ensure that all responses are evidence-based and unbiased.
4. Question: The job description emphasizes stakeholder management. How have you effectively interacted with stakeholders in previous roles, and how do you ensure alignment with their requirements?
Answer: Effective stakeholder management is crucial in medical writing. I’ve maintained strong relationships with stakeholders by actively seeking their input, understanding their needs, and providing timely updates on project progress. I believe in open and transparent communication to ensure alignment with stakeholders’ requirements throughout the project lifecycle.
5. Question: The position requires expertise in medical writing and knowledge of regulatory requirements. How do you stay updated with evolving regulatory standards and ensure compliance in your work?
Answer: Staying updated with regulatory standards is a continuous process. I regularly engage in regulatory training and keep abreast of changes in guidelines. Additionally, I collaborate closely with regulatory affairs teams to ensure that my work aligns with the latest requirements. Compliance is a top priority, and I take proactive measures to incorporate regulatory updates into my writing processes.
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