Position Summary

Primary Responsibilities

• Implements 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 protocols
• Synchronizes, with appropriate project management resources, the timelines and process for preparation, review, approval, and other appropriate functions involved in the production of high-quality documents
• Communicates and tracks deliverables, writing process, and timelines to the Development team and to 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
• 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 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
• Other responsibilities as assigned

Education/Experience/Skills

• Master’s degree in a related field; PhD preferred. An equivalent combination of education and experience may be considered
• Targeting 5 years’ progressively responsible experience in science and medical writing with a focus on clinical and regulatory document preparation, preferably in a pharmaceutical or biotech environment. 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 suggests 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 and engage strong relationships, motivate and influence others, including those over whom they have no direct authority
• Ensures compliance with all Acadia applicable policies, procedures and SOPs
• Willingness and ability to travel domestically and internationally as needed

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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