Write and review various safety reports for global regulatory submissions, including but not limited to Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.
Author and review Risk Management Plans (RMPs), adhoc reports, and medical device reports.
Draft responses to health authority questions or feedback and collaborate with cross-functional stakeholders.
Conduct trainings for peers and junior team members and provide shadowing opportunities.
Author/review manuscripts, abstracts, and posters for conferences.
Perform/review signal detection activities and author signal reports.
Act as a writing coach, devise training programs, and author/review SOPs/WIs/process documents.
Coordinate activities related to report writing across a team of writers, if applicable.
Assist in estimation of resource requirements and responding to Requests for Proposals (RFPs).
Internal and external communication and coordination to obtain required inputs.
Create and update labels, review literature searches, and perform routine surveillance.
Implement and promote consistent, efficient, and quality processes to meet timelines and deliverables.
Ensure compliance with regulatory requirements and maintain a culture of high customer service.

Qualifications:

Bachelor of Pharmacy degree
7 to 11 years of experience in pharmaceutical regulatory writing
Expert proficiency in English language
Strong problem-solving skills and ability to think creatively
Commitment to diversity, inclusion, and equal opportunity employment

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