Senior Director - Medical Writing Operations
October 11
Description
• Coordinates Medical Writing operational needs • Understands regulatory requirements and ICH guidelines • Manages specialty document development writing process • Ensures all specialty documents are quality-checked • Manages key submission documents • Collaborates with Rapid Filing Team • Manages Medical Writing/Regulatory Department SOPs • Facilitates clinical operations and medical writing needs • Authoring, facilitating review cycles, and finalization of documents • Develops and grows the Medical Writing Department • Establishes and manages timelines and relationships • Assignment of writers • Management communication of budgets • Management of Medical Writing contractors and onboarding • Develops and manages department SOPs
Requirements
• BS./B.A. degree • Minimum of 10 years of medical writing experience • Minimum 4 years of business experience managing operations in the Medical Writing function • A very detailed oriented mindset • Ability to write and proofread documents • Proven ability to lead cross-functional teams • Required experience in clinical operations for 2-4 years • Basic understanding of EU CTR and ROW submission document requirements • Excellent team player • Able to work well both independently and as part of a team • Excellent organizational skills • Commitment to company values and culture • Proven ability to adapt to change • Strong oral and written communicator • Self-motivated, with initiative • Skilled in developing collaborative internal and external relationships • Strong PC experience
Benefits
• Medical, dental, vision, and 401k benefits • Unlimited paid time off • Parental leave
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