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Medical Writer II – MLR Reviewer
Syneos HealthMedical Writer II at Syneos Health involved in scientific writing, mentorship, and document management. Collaborate with medical writers and cross-functional teams to produce high-quality document deliverables.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in scientific writing and document management, particularly in Veeva Vault and PubConnect, while ensuring compliance with regulatory standards and guidelines. Capable of mentoring and collaborating with cross-functional teams to produce high-quality medical writing deliverables.
Highest-signal resume keywords
Scientific WritingVeeva Vault Document ManagementPubConnect Workflow ManagementRegulatory ComplianceMentoring Medical Writers
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Medical WritingClinical Manuscript DevelopmentStatistical Analysis ReviewDocument EditingPublication Planning
Soft Skills
CollaborationAttention to DetailCommunication
Tools & Technologies
Veeva VaultPubConnectDatavision
Industry Keywords
MLR Review ProcessClinical Literature SearchesStandard Operating ProceduresBudget Management
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Mentors less experienced medical writers on projects, as necessary.
- Performs E2E process related scientific writing that includes but not limited to manage workflow in PubConnect, create publication plan, author approvals, pre-submission queries, submission activities etc.
- Veeva Vault document management - Creates placeholders, upload versions, reference linking, anchoring and linking, monitors the workflows/task completion.
- Reviews documents intended for Veeva submission and ensures they are fully MLR‑ready by proactively identifying and highlighting content changes needed per standards and guidelines, verifying claims against referenced sources, and streamlining the MLR review process to support first‑round approval.
- Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.
- Develops or supports a variety of documents that include but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Requirements
What you’ll need- Mentors less experienced medical writers on projects, as necessary.
- Performs E2E process related scientific writing that includes but not limited to manage workflow in PubConnect, create publication plan, author approvals, pre-submission queries, submission activities etc.
- Veeva Vault document management - Creates placeholders, upload versions, reference linking, anchoring and linking, monitors the workflows/task completion.
- Reviews documents intended for Veeva submission and ensures they are fully MLR‑ready by proactively identifying and highlighting content changes needed per standards and guidelines, verifying claims against referenced sources, and streamlining the MLR review process to support first‑round approval.
- Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.
- Develops or supports a variety of documents that include but not limited to: Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
- Serves as peer reviewer on internal review team.
- Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
- Adheres to established regulatory standards, including but not limited to congress/journal guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
- 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 that affect medical writing.
- Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
- Completes required administrated tasks within the specified timeframes.
- Performs other work-related duties as assigned.
- Minimal travel may be required (less than 25%).
Benefits
Comp & perks- We are passionate about developing our people, through career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- We are committed to building an inclusive culture – where you can authentically be yourself