Covance

Team Lead, Medical Writing

Job Location(s) IN-Pune
Job Number
2021-71587
Job Category
Medical Writing
Position Type
Full-Time
Telecommute
No

Job Overview

Ensure compliance of operations with governing regulatory requirements
Create, maintain and assume accountability for a culture of high customer service
Write and review various safety reports for global regulatory submissions for Covance’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
Perform project management activities involving internal and external communication, co-ordination, planning and meeting submission timelines
Perform various support activities such as tracking, maintenance of metrics, quality checks and training
Line Management activities:
Support & contribute to on boarding, training, mentoring and coaching of new associates
Identify and arrange appropriate work assignments or formal training to foster individual development
Prepare other team members to assume new or increased responsibilities
Seek opportunities to improve service and quality; leverage Covance capabilities and coach team with respect to customer delight
Continually evaluate work taking into consideration multiple priorities - eliminate unnecessary work; reallocate resources to maintain and enhance effectiveness, thereby adding value to the company and to the client
Provide support in other areas of expertise such as Literature Solutions
Act as a writing coach
Assist in estimation of resource requirement and responding to RFPs as needed

Education/Qualifications

Bachelor’s/Master’s degree in Pharmacy/related science area OR Bachelor’s degree in Medical Science

Experience

At least 5 years’ experience in the pharmaceutical industry, with at least 3 years of it in safety/medical writing and at least 1 year in Line Management activities
Experience in drug discovery and pharmacovigilance, aggregate reports required
Strong written and verbal language skills
Management skills such as customer relationship management, team building, project tracking and management, metrics management and reporting, problem solving, networking, coaching and mentoring team members

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