Job Description

Director, Medical Writing Consultant

W2 Contract

Salary Range: $208,000 - $249,600 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

As a Medical Writing Consultant, you will partner with senior leadership to write high-quality, strategically aligned medical writing deliverables that support clinical, safety, and regulatory clinical program requirements. You will drive the messaging strategy across a program of work and analyze program-level and study-related documents to ensure their ability to deliver the information required by regulatory authorities in a compelling fashion with accuracy and consistency. You will mitigate risks associated with medical writing and disclosure processes by establishing and maintaining Best Practices and SOPs.

Duties and Responsibilities:

• Efficiently prepare high-quality, strategically aligned medical writing deliverables and ensure effective communication underpins successful clinical development.
• Write deliverables for assigned clinical program(s) following budget and timelines.
• Build convincing clinical, safety, and regulatory arguments within and across documents using logic, analogy, and therapeutic area science.
• Ensure that statements in the deliverables are accurate and supported by appropriate data.
• Align, coordinate, and build consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans and continuing through study-level documents to final program-level deliverables (i.e., regulatory submission or publication of key journal articles for a publication plan).
• Understand issues affecting clinical development strategy design and how study design, data capture, and statistical analysis plan design will affect downstream documents.
• Liaise with functional groups within and external to R&D to ensure independent and interdependent communication needs and strategies are considered during document development (e.g., communicating data in a CSR and regulatory documents to support NDA and Advisory Committee positioning).
• Be accountable for medical writing deliverable quality and ensure work on assigned projects adheres to departmental procedures, practices, and industry/international standards.
• Set program-level standards (e.g., style convention).
• Drive the development, implementation, and communication of Best Practices, SOPs, templates, work instructions, style guides, and content guides to ensure efficient preparation of high-quality medical writing deliverables.

Requirements and Qualifications:

• BA/BS or higher and 10+ years of senior-level writing experience in the pharmaceutical industry
• Expert-level experience writing Clinical Study Reports
• Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
• A solid understanding of the clinical development process, including the documents that are required at each stage
• A comprehensive understanding of medical writing processes, standards, and issues
• Expert Microsoft Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics, and templates
• Excellent written and oral communication skills and demonstrated problem-solving abilities.
• Knowledge of eTechnology related to regulatory submission activities (e.g., eCTD).
• Experience in hematology, oncology, ophthalmology, or allergy therapeutic area
• Strong, positive interpersonal skills
• Demonstrated negotiating skills and resourcefulness
• Demonstrated ability to manage several projects simultaneously
• Able to critically analyze, interpret, and synthesize complex scientific information.
• Strong influencing skills; able to lead without formal authority
• A high degree of influencing skills in shaping and developing content and wording
• Can manage uncertainty and shifting priorities and timelines
• Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships; seeks input, and shows an appreciation for diverse views by incorporating them into decisions and proposals
• Successful track record of leading complex clinical/regulatory writing projects
• Demonstrated ability to make decisions even in the absence of complete information
• An excellent understanding of all aspects of ICH-GCP; keen insight into external clinical publication practices and standards (ICMJE, AMA, GPP)
• Excellent organizational and time management skills
• Detail oriented

Desired Skills and Experience

Medical Writing, Clinical Study Reports, clinical development, Microsoft Office, eCTD, Late Stage Clinical Development, Oncology, Ophthalmology, Hematology, ICH Guidelines, SOPs, GCP

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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