Associate Manager, Scientific Writing Operations
Regeneron
11 days ago
On-site
Tarrytown, NY
Operations
Responsibilities:
- Assist in managing project timelines and resources; negotiate timelines across functional areas.
- Assist with project sequencing as directed by senior Scientific Writing Operations personnel.
- Manage creation and maintenance of document templates for cross-functional use.
- Support, drive, and track implementation of technical solutions for Scientific Writing deliverables (authoring tools, templates, trackers, workflow improvements) and coordinate testing/UAT, training materials, communications, and rollout plans to ensure on-time adoption.
- Track and report operational metrics for Scientific Writing tools/processes (cycle times, throughput, adherence) and recommend continuous improvement opportunities.
- Provide backup support for nonclinical document processes (routing, publishing/readiness checks, QC coordination, and author/reviewer handoffs).
You might be a good match if you:
- Partner with cross-functional stakeholders to define user requirements and translate process gaps into actionable technical enhancements.
- Create/review SOPs and Working Practices.
- Participate in cross-functional drug development team meetings.
- Stay current with GxP and regulatory guidelines and relevant company SOPs/WPs.
To be considered, you must have:
- Bachelor’s degree or MS/PhD/PharmD in a life science.
- 3–5 years’ pharmaceutical industry experience.
- PPM (Project Portfolio Management Software) experience.
Preferred/plus:
- Operational/project management support for regulatory/technical writing deliverables (plus).
- 1–2 years on cross-functional drug development teams (strongly preferred).
- Supervisory experience (plus).
- Ability to manage multiple projects; strong organizational/interpersonal/communication skills.
- Computer proficiency (Microsoft Office, Adobe Acrobat, related software) and basic AI usage.
Application:
- Apply now.
- Assist in managing project timelines and resources; negotiate timelines across functional areas.
- Assist with project sequencing as directed by senior Scientific Writing Operations personnel.
- Manage creation and maintenance of document templates for cross-functional use.
- Support, drive, and track implementation of technical solutions for Scientific Writing deliverables (authoring tools, templates, trackers, workflow improvements) and coordinate testing/UAT, training materials, communications, and rollout plans to ensure on-time adoption.
- Track and report operational metrics for Scientific Writing tools/processes (cycle times, throughput, adherence) and recommend continuous improvement opportunities.
- Provide backup support for nonclinical document processes (routing, publishing/readiness checks, QC coordination, and author/reviewer handoffs).
You might be a good match if you:
- Partner with cross-functional stakeholders to define user requirements and translate process gaps into actionable technical enhancements.
- Create/review SOPs and Working Practices.
- Participate in cross-functional drug development team meetings.
- Stay current with GxP and regulatory guidelines and relevant company SOPs/WPs.
To be considered, you must have:
- Bachelor’s degree or MS/PhD/PharmD in a life science.
- 3–5 years’ pharmaceutical industry experience.
- PPM (Project Portfolio Management Software) experience.
Preferred/plus:
- Operational/project management support for regulatory/technical writing deliverables (plus).
- 1–2 years on cross-functional drug development teams (strongly preferred).
- Supervisory experience (plus).
- Ability to manage multiple projects; strong organizational/interpersonal/communication skills.
- Computer proficiency (Microsoft Office, Adobe Acrobat, related software) and basic AI usage.
Application:
- Apply now.