- Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature.
- 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).
- Adapts global scientific response documents for assigned countries.
- Develops responses to escalated inquiries for assigned countries.
- Develops contributions to US NDA Annual Reports.
- Contributes to US compendia reviews.
- Ability to execute the MI projects once they are conceptualized with guidance from experienced team members or mangers
- Demonstrates resolve and urgency to accomplish tasks under the guidance of supervisor. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule.
- Develops and maintains Therapeutic Area expertise.
- Able to conduct quality checks on peer outputs in case of business need
- Collaborates effectively with Global Medical Information teams to execute content plans
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 information content as per requirement.
- Interact effectively with stakeholders in medical and pharmacovigilance departments.
- 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:
- Can work with minimum supervision to conduct data sanity and produce error free MI project outputs for countries supported.
- Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis.
- Implement relevant elements of content plans and associated activities for the year identified for the assigned countries.
- Work with selected vendors within the region to deliver the required deliverables as per the defined process.
- Help to manger to 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.
About you:
Experience: 2 3 years of experience in medical writing for the pharmaceuticals/ healthcare industry or equivalent experience in a clinical setting; At least 1 2 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, Master in science, MBA or equivalent)
Languages: Excellent knowledge of the English language (spoken and written)