Senior Scientific Writer

JOB DESCRIPTION:

Scientific /Medical Writer:
Role Overview
The Medical Writer is an essential individual contributor within the Clinical Science Team
responsible for independently authoring high-quality clinical documentsparticularly Module
2.5 (Clinical Overview) and Module 2.7 (Clinical Summary)for global regulatory
submissions.
This role collaborates closely with Clinical Directors across multiple therapeutic areas to
ensure scientifically sound compliant and timely delivery of clinical modules that support
regulatory approvals.
Core Responsibilities
Authoring Clinical Modules
Independently author update and finalize Modules 2.5 and 2.7 for global regulatory
submissions in alignment with company standards ICH guidelines and agency
expectations.
Ensure documents accurately reflect the clinical strategy and scientific position of
each therapeutic area as defined by respective Clinical Directors.
Cross-Functional Collaboration
Work closely with Clinical Directors and Clinical Science Team from multiple therapy
areas to gather input verify scientific interpretations and align on key narrative
elements within the clinical modules.
Serve as the primary scientific writer responsible for integrating cross-functional
feedback into cohesive submission-ready documents.
Planning & Documentation Strategy
Review clinical development timelines and proactively plan medical writing activities
to meet critical submission milestones.
Advise team members on documentation requirements and identify process
efficiencies.

Regulatory Submission Support
Prepare or coordinate completion of clinical components of registration dossiers and
ensure consistency across all clinical documents particularly following database
updates or clinical strategy modifications.
Support Clinical Directors in preparing responses to Health Authority queries related
to authored clinical modules.
Compliance & Standards
Maintain up-to-date knowledge of clinical documentation expectations of major
Health Authorities especially knowledge of key EM markets and changing landscape.
Communicate potential impacts of changing guidelines or templates to the Manager
and functional leadership.
Act as a Subject Matter Expert in clinical documentation processes and tools
contributing to implementation of new systems or process enhancements.
NEW: Strategic Planning with Global Labeling
Work closely with the Global Labeling team to develop an annual plan for clinical
documentation needed to support product renewals safety updates and regulatory
maintenance activities for clinical.
Define strategic priorities and timelines for required updates to Modules 2.5 and 2.7
and ensure alignment with labeling objectives lifecycle management plans and
regulatory commitments.
Proactively identify upcoming needs for dossier updates based on changes in clinical
data labeling negotiations or evolving regulatory expectations.
Additional Responsibilities
Independently prepare and/or coordinate time-critical clinical reports and regulatory
documents supporting the planning conduct and reporting of clinical studies.
Ensure that the scientific narrative reflects the clinical viewpoint established by the
Clinical Directors and departmental leadership.

Liaise with external partners (CROs co-development partners affiliates) and internal
teams (data management biostats publishing) to ensure accuracy and
completeness of tables figures and appendices.
Required Knowledge & Skills
Minimum 5 years of industry experience as a Medical Writer with a strong track
record in developing major clinical submission documents.
Proven ability to author clear accurate scientifically robust clinical documentation
including complex or high-visibility documents.
Strong organizational skills attention to detail and ability to manage multiple
deliverables under tight timelines.
High proficiency in Microsoft Word and comfort working in electronic document
management systems.
Excellent written and spoken English.
Education & Experience
Advanced scientific degree (Masters PhD PharmD MD or equivalent).
At least 3 years of medical writing in relevant clinical submission / module
development.
Strong understanding of clinical development methodology clinical study operations
statistics and regulatory frameworks.
Desirable
Familiarity with therapeutic areas relevant to the company pipeline.
Experience collaborating with Global Labeling or Regulatory Affairs teams.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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