The Director of Regulatory Affairs (RA) Labeling will lead the development of a cross functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with Labeling Management Team (LMT) and Executive Labeling Committee (ELC), a

Provide scientific and medical leadership, including development of strategic plans, identifying specific unmet medical needs, and data gaps. Establish appropriate strategic partnerships with centers of excellence, advocacy groups and KOLs in areas of scientific interest. Lead the design and execution of the medical plan and tactics including Real World Evidence generatio

Support the overarching strategic engagement plan for the Rett community to drive brand awareness. Support Caregiver Educational programs, including content development, relationship management and event oversight. Manage and Implement patient CRM strategy for both unbranded disease education and branded promotions that align with the patient journey Manage internal and e

Support with developing draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management Support implementation of a labeling review and approval process, including documentation of label history, LMT/ELC decisions, and exceptions from CCDS to facilitat

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average. This position serves a key leadership role in the organization as the portfolio program leader in support of the cross functional strategy for the programs (assets) in the Rare Disease franchise. This role contributes to

Lead a team of FAMs to ensure successfully starting and continuing patients on therapy Lead execution of strategic and tactical initiatives Drive implementation of payer coverage policies in conjunction with field based National Accounts team Drive change/resolution of coverage policy issues with field based National Accounts team, including commercial and government paye

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average. This position will serve as a technology partner in the Research and Development (R&D) and Technology Development & Operations (TD&O) domains, providing technology leadership, operational support and project management fo

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average. Responsible for directing the regulatory aspects of internal and external communications including advertising and promotional activities as well as facilitation of labeling development, maintenance and distribution for a

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average. Performs a variety of accounting responsibilities while ensuring compliance with Generally Accepted Accounting Practices (GAAP), Sarbanes Oxley (SOX) and company policies and procedures. Primary Duties and Responsibilitie

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average. Responsible for enhancing internal processes and systems to drive greater efficiency to best support the business as we continue to grow and scale including implementing new technologies, processes and systems integration

Please note that this position is based in San Diego, CA AND/OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. The Director of Quality Audits & Compliance is responsible to independently lead, manage, and coordinate Quality GCP and GLP regulated activities and is responsible for performance of domestic and int

Seeking Talent Near Los Angeles, CA; San Francisco, CA; Seattle, WA; Phoenix, AZ Responsible for the development and execution of thought leader strategy, tactical plans and activities that drive strong thought leader engagement based on science, and commitment to patients across all marketing channels. The behaviors that are critical for success are collaboration, commun

Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average. The Associate Director will support the strategic direction and oversee the tactical execution of operations for the Medical Affairs (MA), Rare Disease supporting the DAYBUE (trofinetide) launch and expansion efforts. Thi

Please note that this position is based in San Diego, CA and Acadia's hybrid model requires this role to work in our office three days per week on average. Responsible for oversight of the outsourced analytical development activities associated with the development, validation, technology transfer, and line extension of drug product. Support pre formulation and drug produ