Senior Medical Writer, Clinical and Regulatory Strategic Communications (CRSC)

Job Description

The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (GCTO) creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.

• Demonstrates independence in preparing clinical regulatory (e.g. protocols clinical study reports participant narratives investigators brochures) and/or public-facing (e.g. informed consent forms clinical trial registration and results postings plain language summaries) documents per company and evolving regulatory requirements.
• Applies an in-depth knowledge and understanding of design planning authoring editing and review of accurate clear high-quality documents that reflect applicable medical writing best practices (e.g. lean writing health literacy).
• Is a scientific contributor and collaborator on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities.
• Applies emerging critical thinking problem solving and negotiation skills to implement solutions to challenges across the medical writing scope of work (e.g. documents content processes timelines tools) while navigating project team dynamics. Keeps medical writing project lead and/or management informed and escalates as needed issues that could impact timelines quality or compliance.
• Applies knowledge of medical writing-specific tools and technology platforms.
• Participates in or leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally as appropriate.
• Applies knowledge of clinical development relevant regulations disease areas and company products.
• May help with other departmental needs such as orientation of new team members or mentoring less experienced writers.
• May manage direct reports including workload professional development and performance management.

Qualifications

• Required:
  • Bachelors degree preferably in a health scientific or relevant discipline (e.g. life sciences pharmacy medicine public health)
  • 3 years of relevant medical writing or industry experience

Required skills & experience

• Experience managing multiple writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
• Ability to interpret clinical data clearly objectively and in accordance with regulatory requirements and industry guidelines with minimal supervision.
• Demonstrated critical thinking and problem-solving capabilities.
• Experience with conflict resolution and negotiation in cross-functional teams.
• Ability to adapt to changing project needs and unexpected workload demands to help team succeed.
• Strong oral and written communication and presentation skills.
• Technical expertise in commonly used office applications (e.g. Microsoft Office Suite) and shared document systems (e.g. SharePoint) and willingness to learn and adapt to emerging technology.

Preferred skills & experience

Clinical and Regulatory Medical Writer (MW):

• Experience independently preparing a subset of clinical regulatory documents (e.g. protocols clinical study reports participant narratives investigators brochures) in accordance with regulatory requirements and industry guidelines.

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Required Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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