The Director, Medical Writing is responsible for leading writing strategies and driving document content development to meet organizational goals.  This position will develop and manage document timelines, partner with SMEs across the organization to author and review key regulatory documents and oversee internal and external medical writing resourcing to support authoring and QC needs.

The Director of Medical Writing will provide leadership in the development of global writing processes, standards, and templates, as well as perform outreach within the pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and to establish medical writing best practices within the company.  This role will be a strategic partner to teams and responsible for efficiently preparing high-quality, strategically aligned medical writing deliverables

Position Specific Responsibilities:

• Develop and implement document templates, style standards, reference library, reviewer guidelines, SOPs and quality control checklists, to ensure consistent and high-quality deliverables
• Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables, including the identification, selection, and oversight of qualified full- or part-time medical writers, vendors, consultants, or contractors
• Lead writing strategy, drive document content and organization, develop and manage timelines, and lead comment resolution in the preparation of clear and concise clinical, nonclinical and regulatory documents supporting regulatory submissions
• Partner with SMEs to analyze, summarize, and interpret non-clinical and clinical data
• Collaborates with cross-functional team to review study results
• Contributes scientific knowledge and analytical skills to the production of documents
• Participates in developing key messages for routine documents and conducts literature searches
• Ensures the accuracy and QC of submission-ready documents
• Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs and Clinical Operations
• Represents Regulatory Medical Writing as a cross-functional team member for clinical study level activities
• Supports clinical study execution through expert review of study-level documents authored by other functions (e.g., study deviations, analysis plans, data outputs)

Specialized Knowledge & Skills:

• Excellent written and oral communication skills, including functional literacy, collaboration and consensus building
• Proven ability to act as lead author and project manager on different types of documents
• Ability to analyze, summarize, and interpret clinical data
• Expertise in MS WORD, standardized templates, PleaseReview and Endnote
• Basic knowledge of FDA, EMA, and ICH guidelines
• Has flexibility to react rapidly to changing situations/environment.
• Ability to think intuitively and problem solve
• Experience working on complex projects, within cross-functional clinical and/or project teams
• Strong knowledge of current industry trends and the ability to use the latest technologies.
• Demonstrated ability to partake or lead interdisciplinary projects, work in cross-functional matrix, and to effect change within a high-performing organization
• A clear sense of personal accountability, an ability to empower people, ability to drive deliverables with partners with a high degree of mutual respect and integrity are essential factors to succeed

Requirements:

Educational Requirements:

• Bachelor of Science with significant relevant writing experience OR Bachelor’s degree in English or communications with 8+ years relevant pharmaceutical experience OR Advanced degree (Masters/PhD) with 5+ years of relevant experience.

Experience:

• Experience should have been gained directly in pharmaceutical/biotechnology companies and include authoring a wide range of documents (eg, protocols, IBs, CSRs, briefing books, PIPs, special designation requests, documents contributing to global submissions, such as INDs, NDAs/BLAs, and MAAs) from inception through completion.