[Hiring] Medical Writer II @Syneos Health

Role Description

The Medical Writer II (MLR Reviewer) is responsible for the following:

• Mentors less experienced medical writers on projects, as necessary.
• Performs E2E process related scientific writing, including:
  • Manage workflow in PubConnect
  • Create publication plan
  • Author approvals
  • Pre-submission queries
  • Submission activities
• Veeva Vault document management:
  • Creates placeholders
  • Upload versions
  • Reference linking
  • Anchoring and linking
  • Monitors workflows/task completion
• Reviews documents intended for Veeva submission to ensure they are MLR-ready by:
  • Identifying and highlighting content changes needed per standards and guidelines
  • Verifying claims against referenced sources
  • Streamlining the MLR review process to support first-round approval
• Compiles, writes, and edits medical writing deliverables, serving as a medical writer within and across departments with minimal supervision.
• Develops or supports a variety of documents, including:
  • Clinical journal manuscripts
  • Clinical journal abstracts
  • Posters
  • Oral presentations
• Reviews statistical analysis plans and table/figure/listing specifications for:
  • Appropriate content
  • Grammar
  • Format
  • Consistency
• Interacts with department head and staff members in:
  • Data management
  • Biostatistics
  • Regulatory affairs
  • Medical affairs
• Serves as peer reviewer on internal review team, addressing team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
• Adheres to established regulatory standards, including:
  • Congress/journal guidelines
  • Company Standard Operating Procedures
  • Client standards
  • Company and/or client approved templates
• Performs online clinical literature searches, as applicable.
• Familiarity with publication planning software (e.g., Datavision and PubConnect, VeevaVault PromoMats or Medcomms).
• Continues professional development to keep pace with regulatory guidance and client expectations in medical writing.
• Stays aware of budget specifications for assigned projects, working within budgeted hours and communicating changes to medical writing leadership.
• Completes required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications

• Experience in medical writing and regulatory standards.
• Strong communication and mentoring skills.
• Ability to work independently and collaboratively.
• Familiarity with publication planning software.

Requirements

• Proven experience in scientific writing.
• Knowledge of clinical research and regulatory processes.
• Attention to detail and ability to meet deadlines.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Inclusive culture where you can authentically be yourself.