The Position 

The Associate Director, Regulatory/Medical Writing collaborates with members of cross‑functional teams to prepare high-quality regulatory and clinical documentation for submission to global regulatory agencies including the preparation of components for INDs/NDAs, annual reports, Orphan Drug Designation applications, and briefing books as well as clinical study documentation such as protocols, investigator brochures, etc as required within agreed-upon timelines. The Associate Director also assists with the preparation of publications, abstracts, and other external communications in support of Arrowhead business functions. The Associate Director also assists in implementing processes and standards to ensure company scientific documents are prepared to the highest editorial standards and quality.

Responsibilities

• Prepares, edits, and finalizes protocols, investigator brochures, synopses, clinical study reports, regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, briefing books, etc)
• Prepares related clinical documents, such as abstracts, posters, presentations, and manuscripts
• Collaborates with and manages contract medical writers as required for project assignments
• Advises and assists in the review and management of nonclinical and CMC technical reports as required
• Develops and maintains company house-standard templates and best review practices for regulatory and clinical documentation. Ensure vendors and contractors maintain company standards
• Participates in regulatory and clinical team strategy meetings to ensure that that results and messages in clinical documents accurately reflect the data in tables, figures, and listings (TFLs) and other information sources Partners with the scientific staff including participation in the review of mock and/or blinded TFLs, and narrative planning for relevant documents
• Assists in the development and maintenance of Development Core Product Data Sheets, draft labeling, and company work instructions and SOPs, as requested
• Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines and medical editorial boards
• Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. Schedules and conducts document-related meetings including kickoff meetings and document review planning and alignment discussions to ensure documentation timelines are achieved
• Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in appropriate document management system(s)
• Ensures that appropriate documented quality control (QC) checks are performed on regulatory/medical writing deliverables, responds to findings, and recommends quality process improvements

Requirements: 

• Bachelor’s degree in medically related field or life science
• 6 to 8 years of relevant medical writing experience in the pharmaceutical industry is essential
• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing. Familiarity with basic statistical analysis concepts and techniques is required
• A demonstrated track record of contribution to successful regulatory components used in filings eg, IND/CTAs, NDA/BLA/MAAs is important
• Prior experience in interacting with cross-functional study team members is essential
• Highly proficient in the use of MS Word, Excel, Endnote, Adobe Acrobat, PowerPoint, and structured document templates

Preferred: 

• Post-graduate degree (master’s or doctoral)
• Experience with electronic document management systems 
• Experience writing in one or more of the company’s key therapeutic areas eg, liver disease, respiratory disease, or rare diseases
• Membership in professional medical writing, regulatory, or drug information associations