Senior Medical Writer

Regeneron Pharmaceuticals • Armonk, NY

1d • Onsite

About The Position

The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to contribute to other regulatory documents may be provided. The SMW tracks his/her own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion. In this role, a typical day might include: Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be provided Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict May review the work of junior and outsourced MWs May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion Writes in plain language style as appropriate (eg, for ICFs) Explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience May mentor junior staff Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area Remains compliant with internal training This role might be for you if can: Drives document development meetings Articulates document strategy and timelines Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly

Requirements

• Bachelor's degree (advanced degree preferred)
• Minimum of 3 years of relevant MW experience including working knowledge of biostatistics.
• Strong knowledge of the clinical research process and regulations/guidelines
• Clinical document reading, writing, and editing experience
• Strong organizational, interpersonal and communication skills
• Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems
• Ability to manage multiple projects
• Familiarity with ICH GCP guidelines

Responsibilities

• Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas.
• Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development
• Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict
• May review the work of junior and outsourced MWs
• May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion
• Writes in plain language style as appropriate (eg, for ICFs)
• Explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience
• May mentor junior staff
• Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area
• Remains compliant with internal training
• Drives document development meetings
• Articulates document strategy and timelines
• Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss
• Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees