Associate Director/Director, Medical Writing

Associate Director/Director, Medical Writing

W2 Contract

Salary Range: $228,800 - $249,600 per year

Location: Redwood City, CA - Remote Role

Job Summary:

As a strategic partner to senior leadership, the Associate Director/Director, Medical Writing, is accountable for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical, safety, and regulatory requirements of a clinical program. They are also responsible for driving the messaging strategy across a program of work, and for analyzing program-level documents and study-related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.

Duties and Responsibilities:

• Responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables and ensuring effective communication underpins successful clinical development.
• Responsible for the efficient preparation of high-quality medical writing deliverables for assigned clinical program(s) according to budget and timelines.
• Builds convincing clinical, safety, and/or regulatory arguments within and across documents using logic, analogy, and therapeutic area science.
• Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
• Responsible for aligning, coordinating, and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study-level documents to final program-level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan).
• Understands where all intended messages will be located across individual documents within a clinical program and ensures alignment of messaging across documents.
• Understands issues affecting the design of clinical development strategy, and understands how study design, data capture, and statistical analysis plan design will affect downstream documents.
• Liaises 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).
• Accountable for medical writing deliverable quality and ensuring work on assigned projects adheres to departmental procedures/practices and industry / international standards.
• Sets program-level standards (e.g., style convention).
• Drives 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 at least 6 years of writing experience at the senior level in the pharmaceutical industry
• 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 MS 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).

Preferred Qualifications:

• Experience in hematology / oncology / ophthalmology / allergy therapeutic area
• Ability to think strategically
• Strong, positive interpersonal skills
• Demonstrated negotiating skills and resourcefulness
• Demonstrated ability to manage several projects simultaneously
• Ability to critically analyze, interpret, and synthesize complex scientific information
• Strong influencing skills, able to lead without formal authority
• High degree of influencing skills in shaping and developing content and wording
• Can manage uncertainty, shifting priorities, and timelines
• Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input, and demonstrates an appreciation for diverse views by incorporating them into decisions/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
• Attention to detail

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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