Associate Director, Medical Writing

Responsibilities

• Authors routine clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions) in partnership with cross-functional team with oversight
• Performs quality checks of documents and data files
• Performs technical edits and formatting of documents, maintains templates, SOPs, Style Guides, and work instructions
• Communicates proactively and efficiently within the MW team and across other functional areas
• Supports clinical study execution through expert review of study-level documents authored by other functions (e.g., study deviations, study manuals, consent forms, analysis plans, data outputs)
• Coordinates and leads document submission workflows (eg, kick-off meetings, roundtables, reviews, quality control (QC) and other  content activities, approvals) by managing issues and facilitating resolutions
• Works with project management to develop timelines for documents and communicates with team members to maintain awareness of expectations, milestones, and deliverables
• 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
• Reviews clinical trial registry postings for assigned studies
• Stays current with respect to key global guidance documents, regulations, or directives
• Works effectively with an electronic document management system and related tools to develop clinical documents
• Maintains effective working relationships with contractors, vendors, and partners

Requirements

• Experience and knowledge in the preparation of documentation supporting global regulatory submissions. Experience with marketing applications is a plus, but not required
• Experience producing high-quality scientific/medical documents
• Ability to understand, analyze, interpret, and summarize clinical and scientific data
• Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
• Basic project management skills
• Initiative and creativity in solving routine problems for individual documents and identifying process improvements within the Medical Writing department
• Attention to detail related to consistency, grammar, syntax, and scientific accuracy
• Basic computer skills related to word processing, templates, table/figure creation, and literature searches
• Knowledge and understanding of applicable US and global regulations and guidance
• Knowledge of eCTD content/format requirements
• Excellent verbal and written communication skills
• Strong organizational skills
• Strong interpersonal skills and ability to work effectively with a variety of personnel including contract medical writers
• Bachelor's degree
• 5+ years of experience writing clinical regulatory documents

The starting base pay range for this position is $168,762.00 - $194,140.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!