Job Overview
Acts as Lead Medical Writer on various projects, preparing documents according to IQVIA SOPs and client requirements, adhering to timelines. Performs senior reviews, provides feedback, and stays updated on medical writing and regulatory developments.
Essential Functions
* Lead the preparation of assigned documents, manage timelines, and communicate with clients.
* Plan workload, track progress, and incorporate customer requests.
* Handle new document types and challenging topics independently.
* Lead meetings, resolve conflicts, and participate in bid defenses.
* Design and deliver training sessions, possibly act as Project Manager for complex projects including budget management.
* Draft SOPs, review SOPs, and represent the region in initiatives.
Qualifications and Skills
* Bachelor's in life sciences; Master's or Ph.D. preferred.
* At least 7 years of relevant regulatory writing experience.
* Deep knowledge of CSR, CTD, protocols, and statistical methods.
* Proven leadership in medical writing, excellent communication, and negotiation skills.
* Ability to manage multiple projects and establish effective relationships.
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