Director Medical Writing

Position Summary:

Drives the compilation and preparation of clinical and regulatory documents and other summaries of key data and project summaries in collaboration with project teams for the purpose of product development and submissions to various regulatory authorities. Converts scientific data into a clear, scientifically sound, well-structured scientific, clinical, and regulatory submission document to global health authorities which follow relevant styles and references in support of the company’s product development plans and objectives.

Primary Responsibilities:

• Implements all activities related to the preparation of defined documents (from planning/story-line development to writing, to the facilitation of review and approval, and final formatting). Documents to be assigned may include briefing books, cover letters, summary documents, etc, as well as other development-related documentation such as investigator brochures, clinical study reports, and slide decks
• Synchronizes, with appropriate project management resources, the timelines and processes for preparation, review, approval, and other appropriate functions involved in producing high-quality documents
• Communicates and tracks the needed deliverables, writing process, and timelines to the Development team and to executive management, as appropriate
• Converts relevant data and information into documents consistent with all applicable regulatory requirements
• Works with all relevant team members to develop strategy and content outline for the submission, and to assign content partners for key sections of the document
• Serves as writing lead on assigned documents
• Provides clinical/regulatory writing expertise and strategic input for multiple compounds and/or projects within and across therapeutic areas as part of the preparation of assigned documents
• Communicates with internal and external groups (e.g., Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Rare Disease, and Quality) to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents
• Ensures all clinical and regulatory electronic document deliverables are processed and compiled in alignment with timelines and relevant templates/standards
• Understands, assimilates, and interprets sources of information with appropriate guidance/direction from the Development team or other content experts
• Explains data in a manner consistent with scientific principles and regulatory requirements and with excellent diction, style and grammar
• Verifies completeness of information presented and ensures that the strategic goals of the document are met
• Understands and complies with appropriate conventions, proper grammar usage, and correct format requirements per International Conference on Harmonization (ICH) and other governing bodies following applicable regulations, guidelines, templates, and Acadia SOP requirements
• Identifies and proposes creative and strategic solutions to resolve issues and questions arising during the writing process, including escalation as appropriate
• Maintains up-to-date compliance with all current Acadia and industry requirements as they relate to regulatory submissions by continually training and staying abreast of the latest developments
• Provides guidance and oversight to contract writers and external vendors/agencies when necessary.
• Fosters innovation and improvement related to medical writing processes and documents.

Education and Experience:

• Requires a Master’s degree in a related field; PhD preferred.  Targeting 10 years’ progressively responsible experience in science and medical writing with a focus on medical and regulatory document preparation. An equivalent combination of relevant education and experience may be considered.
• American Medical Writing Association (AMWA) certification or other is strongly preferred, with a specialty in Pharmaceutical Writing.  
• Exceptional writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured ‘story’.
• Ability to self-edit and improve own work to ensure readability, accuracy, consistency and aesthetic presentation of data and information.
• Knowledge of US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissions. 
• Knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/MAA and other regulatory documentation. 
• Working knowledge of current electronic document management systems and publishing systems.
• Ability to assimilate, interpret and translate information/data for appropriate audiences.
• Excellent working knowledge of software programs in Windows environment with high proficiency in word processing, flow diagrams, and spreadsheets.
• Ability to learn fast, grasp the 'essence' of a strategy or a story quickly to convert relevant scientific data/information into high quality summaries and reports.
• Flexibility in the face of changing priorities and ability to change course, if needed, to improve or adjust a document when data or a new strategic direction suggest a need to do so.
• Creates a learning environment; open to feedback and suggestions and innovation for improvement
• Embraces the ideas of others and cultivates a collaborative environment in order to complete assignments effectively.
• Ability to build strong relationships, motivate and influence others, including those over whom they have no direct authority.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  Ability to travel independently overnight and/or after hours if required by travel schedule or business needs.

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