Neurocrine Biosciences

Content Writer

• Prepares and reviews clinical/regulatory documents to support all phases of drug development
• Leads the writing activities of an interdisciplinary team to develop documents that are concise, high quality, and comply with internal and external standards
• Authors and manages the authoring process for all clinical/regulatory documents (e.g., clinical study protocols, clinical study reports, investigator brochures, briefing documents, M2 Clinical Summary Documents for INDs, NDAs, MAAs, annual safety update reports, response to regulatory questions, Pediatric Investigational Plans, and other regulatory documents)
• Leads and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, Preclinical, and Regulatory) from a writing and scientific perspective
• Leads data interpretation and comment resolution meetings
• Ensures document content is clear, concise, strategic, and well positioned for public disclosure
• Supports authoring best practices and provides continued training to teams
• Represents Medical Writing Department on project teams
• Mentor, and may manage, internal staff
• Represents Medical Writing on departmental projects and cross-functional teams
• Supports other lead writers on NDAs and MAAs
• Other duties as assigned

Senior Manager, Medical Writing

Operations

• Responsible for a specific geographic territory and the successful promotion and growth of Neurocrine products.
• Manages and develops long-term relationships with physicians and other customers for targeted accounts in their assigned territory and represent Neurocrine brand(s) and their approved indications.
• This role also plays an important part in educating external customers such as physicians, nurses, medical assistants, case managers, etc. and helping them learn about the benefits of our product(s).
• Drives product acceptance and growth through targeted education and strategic account management.
• Executes territory sales strategies to meet or exceed objectives via in-person and virtual communications.
• Identifies and addresses territory-specific opportunities and barriers to product success.
• Effectively manages promotional resources and budget.

NeuroPsych Account Specialist

Manager

• Provide field access support services and education to Healthcare Professionals (HCPs), helping to maximize patient access to Company products and accelerate time to treatment.
• Communicate with all Specialty Pharmacies (SPs), Closed Door Pharmacies (CDPs) – including Genoa, and Patient-Physician Services (HUB partner) in support of Neurocrine Biosciences marketed products in the U.S.
• Build and uphold the integrity of Neurocrine Biosciences pharmacy distribution network by conducting all vetting activities within an assigned geography.
• Provide support & education to all HCP entities on coverage issues for on-label prescriptions for Company products already in process.
• Work cross-functionally and collaboratively with field sales, network pharmacies, market access, commercial analytics and operations.
• Create material useful in building customers’ awareness of critical coverage requirements.

Regional Patient Access Manager

• Provide field access support services and education to Healthcare Professionals (HCPs), helping to maximize patient access to Company products and accelerate time to treatment
• Communicating with all Specialty Pharmacies (SPs), Closed Door Pharmacies (CDPs) – including Genoa, and Patient-Physician Services (HUB partner) in support of Neurocrine Biosciences marketed products in the U.S.
• Building and upholding the integrity of Neurocrine Biosciences pharmacy distribution network by conducting all vetting activities within an assigned geography
• Provide support & education to all HCP entities on coverage issues for on-label prescriptions for Company products already in process; access support services, processes and forms; education on payer specific coverage issues and Company patient financial support programs
• Subject matter expert on regional and national payer coverage policies & processes
• Work cross-functionally and collaboratively with field sales, network pharmacies, market access, commercial analytics and operations
• Work closely with Payer Marketing, creating material useful in building customers’ awareness of critical coverage requirements
• Ensuring the distribution network is operating at the highest levels of effectiveness by utilizing end-user feedback
• Continuously monitor processes, propose new strategies related to workflow and share best practices with trade leadership on specialty distribution efficiency

NeuroPsych Regional Patient Access Manager

• Provides field access support services and education to Healthcare Professionals (HCPs)
• Communicates with all Specialty Pharmacies (SPs) and Closed Door Pharmacies (CDPs) in support of Neurocrine Biosciences marketed products
• Builds and upholds the integrity of Neurocrine Biosciences pharmacy distribution network by conducting vetting activities
• Provides access support services, processes and forms to HCP entities on coverage issues
• Works cross-functionally and collaboratively with field sales, network pharmacies, market access, commercial analytics and operations
• Monitors processes and proposes new strategies related to workflow

LTC Regional Patient Access Manager

Compliance

• Provides strategic regulatory leadership of programs in a therapeutic area (TA), overseeing and directing all regulatory activities across the entire product lifecycle.
• Drives collaboration with cross-functional partners (eg, Clinical, Quality, Drug Safety & Pharmacovigilance, Legal, Government Affairs & Public Policy, Patient Advocacy) to ensure consideration of regulatory perspectives.
• Devotes significant time to talent and workforce development.
• Sets the tone for the group from a leadership perspective.
• Performs due diligence activities.
• Serves as a trusted advisor across the company and may be recognized as an expert externally.
• Key member of the Regulatory Strategy Leadership Team driving the development and execution on regulatory strategies and strengthening the organization’s capabilities and readiness to deliver on the company’s business priorities while enabling long-term growth
• Represents regulatory strategy at the TA and Development & Market Strategy Team levels, as well as other enterprise level governance forums and corporate initiatives
• Provide strategic regulatory oversight and hands-on execution for a variety of programs from early phase to post-marketing including successful leadership of marketing authorization applications to EMA, Swissmedic, and MHRA
• Provides guidance on complex regulatory issues to teams & senior management, ensuring broad understanding of benefits and risks of different regulatory strategies
• Develops and maintains productive external relationships (eg, with regulators, peers at other companies) to advance company interests
• Consulted on regulatory research conducted by other team members; provides advice and suggestions for further areas of inquiry
• Advises on translating regulatory requirements into strategy and business opportunity
• Develops and mentors high-performing teams and future leaders, fostering accountability, innovation, and cross-functional alignment
• Champions ethical professional behavior; creates conditions for a productive and respectful work environment
• Ensures compliance with regulatory requirement

Executive Director, Regulatory Strategy

Vice President

• Responsible for the company's strategic intellectual property (IP) efforts worldwide for its US-based biologics portfolio
• Supports the company's business in connection with IP portfolio objectives and management, with leadership responsibility for patent prosecution, maintenance and enforcement
• A strategic leader of the in-house IP team and outside counsel relationships
• Overseeing and strategically managing the portion of Neurocrine’s in-house patent team that is dedicated to its US-based biologics portfolio, as well as the related efforts by outside counsel
• Participating actively in the company’s IP leadership team while reporting directly to Neurocrine’s Swiss-based Global Head of Intellectual Property
• Providing hands-on direction and input, to draft and review a wide variety of work product
• Recommending and implementing changes as needed over time to IP-related infrastructure and staffing to maintain good alignment between the company's needs, priorities and resources and the structure of the company's internal and external IP staffing and resources
• Identifying and navigating patent opportunities and risks worldwide for Neurocrine's business, programs and operations for the US-based biologics portfolio
• Driving IP due diligence, technology assessments and freedom to operate (FTO) analyses in potential strategic transactions (including partnerships, potential M&A, licensing and financing), as well as supervising outside counsel in the same
• Counseling key stakeholders in protecting and defending IP rights worldwide, including the Global Head of Intellectual Property, the General Counsel, other senior management and the board of directors, with particular attention to management of the IP portfolio for Neurocrine's lead assets as well as early-stage research programs
• Providing broad-based strategic and portfolio advice, with demonstrated leadership skills and a vision of success tied to larger organizational goals
• Proactively counseling all levels of the organization on IP matters, ranging from broad strategic objectives to day-to-day collaboration with and input to research and development groups and teams
• Managing in-house and outside counsel in the conduct of IP-related proceedings, challenges, disputes and litigation, including the management of biosimilar litigation matters
• Generating budgets, forecasting expenses and resource needs for the drafting, prosecution, maintenance, and enforcement of Neurocrine's patents relating to its US-based biologics portfolio
• Coaching and mentoring IP team members, and proactive in sharing knowledge and collaborating with Neurocrine teams and stakeholders
• Conducting and enhancing the company's IP-related processes and protections, including portfolio reviews and long-range planning, patent review committee, invention disclosures, pre-publication review, and drafting/review of IP-related contract provisions
• Other duties as assigned

VP, Intellectual Property – Biologics

• Lead regional sales team by recruiting, developing, and retaining top talent
• Provide strategic direction and performance coaching to achieve team excellence
• Support team development and ensure proper onboarding of new team members
• Drive regional implementation of sales strategies to meet or exceed sales objectives
• Develop targeted strategies for psychiatric and neurological markets
• Identify regional opportunities and remove barriers to team success
• Foster innovative sales approaches and best practices
• Analyze sales data and market trends to inform strategic decisions
• Hold team accountable for execution of sales strategies and meeting objectives
• Consistently spends time with each account specialist in the field to observe and coach performance
• Provide regular performance feedback and development opportunities
• Manage regional budgets and expenses effectively
• Ensure compliance with Neurocrine policies, FDA guidelines, and industry standards
• Maintain open communication between field teams and headquarters
• Develop and maintain relationships with key opinion leaders and healthcare professionals
• Engage with local professional and patient advocacy groups
• Coordinate with pharmacies and payers to optimize market access
• Align with marketing, training, sales operations and other departments