Senior
Executive @ Pfizer Post Graduate in Pharmacy or Science Apply Now
Managing
individual projects of benefit to therapeutic area teams within the group
Day
to day provision of general assistance to Strategists in the compilation of
regulatory dossiers, coordination of marketing applications and responding to
regulatory questions received from health authorities, as well as compilations
of responses to queries that can serve multiple purposes
Support
for use of regulatory systems and managing documentation and information,
including setting up standard formats or reports for recurring requests and
status updates as needed.
Specific
Maintain
Regulatory Product profile documents by updating as requested by strategist
when key milestones occur. Including
status of product indications supplement status per AG settlement
Provide
targeted documentation searches in GDMS in support of responding to Health
Authority queries and/or internal queries (such as AG settlement information
search or searches to support medical information responses)
Support
for harmonization of Core Data Sheet (CDS) documents (multiple CDS per product)
by preparing label comparison documents
Complete
data entry for PEARL updates as needed based on email template from PCOs
Prepare
and manage viewpoint items for planned submissions as needed
Maintain
tracking report for upcoming and pending approval submissions to facilitate
communications with downstream team members such as Ad/Promo Regulatory,
Commercial and PGS
Prepare
draft meeting notes and action item lists for Labeling and Rapid Response Team
(RRT) meetings as needed
Qualifications
Must-Have
Education:
Post Graduate in Pharmacy or Science.
Experience
: Minimum 2 years of experience
Skills: Required – excellent written, listening and
verbal communication skills, ability to problem solve, technical aptitude
ability to quickly learn and use new software, regulations and quality
standards, attention to detail, ability to work independently with appropriate
level of supervision, experience in customer service environment, aptitude in
project management and logistics
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