Associate Manager, Scientific Writing Operations

About the role

Assists in managing project timelines and resources and negotiates timelines across various functional areas. Assists with project sequencing, as directed by senior Scientific Writing Operations personnel. Tracks and reports operational metrics for Scientific Writing tools and processes (e.g., cycle times, throughput, adherence) and recommends continuous improvement opportunities. Manages creation and maintenance of document templates for cross-functional use. Supports, drives, and tracks implementation of technical solutions that enable Scientific Writing deliverables (e.g., authoring tools, templates, trackers, and workflow improvements) and coordinates implementation activities (testing/UAT, training materials, communications, and rollout plans) to ensure solutions are delivered on time and adopted by end users.

Responsibilities

• Provides backup support for nonclinical document processes to maintain continuity of key workflows (e.g., document routing, publishing/readiness checks, QC coordination, and handoffs between authors and reviewers)

Requirements

• Partners with cross-functional stakeholders to define user requirements, document business needs, and translate Scientific Writing process gaps into actionable technical enhancements
• Creates and reviews SOPs and Working Practices pertinent to areas of responsibility
• Participates in relevant cross-functional drug development team meetings
• Abides by and keeps current with GxP and regulatory guidelines and all pertinent company SOPs or WPs

Qualifications

• Bachelor's degree or MS/PhD/PharmD in a life science
• Minimum of 3-5 years experience in the pharmaceutical industry
• Must have PPM (Project Portfolio Management Software) experience
• Experience with operational/project management support for regulatory or technical writing deliverables is a plus
• 1-2 years of experience participating in cross-functional drug development teams is strongly preferred
• Previous experience in supervising is a plus
• Ability to manage multiple projects and excellent organizational, interpersonal and communication skills required
• Computer proficiency (Microsoft Office Suite [Word, Excel], Adobe Acrobat, and related software) and basic experience with job-relevant AI usage are required

Benefits

• Competitive and comprehensive total rewards package including annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits

Pay

$109,900.00 - $179,300.00 annually

Schedule

Full time