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Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading the writing activities of a multi-disciplinary team to develop documents that are concise, high quality, and comply with internal and external standards. Medical Writing activities include leading the authoring process, identifying and managing contractors, planning New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs), and building the submission writing team with in-house and contract resources. The ideal candidate will live in or be able to relocate to San Diego, we offer great relocation support. _ Your Contributions (include, but are not limited to): Leads the authoring process for all clinical/regulatory documents (eg, 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, PIPs and PSPs, and other regulatory documents as appropriate Leads multi-disciplinary teams and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, nonclinical, Clinical Pharmacology and Regulatory) from a writing and scientific perspective Interprets and presents scientific data, leads comment resolution meetings Ensures document content is clear, concise, strategic, and well positioned for public disclosure Leads and implements best authoring best practices and provides continuous training to teams Mentor internal staff Represent Medical Writing on departmental projects and cross-functional teams Assist other writers on NDAs and MAAs Proven leader who is confident, open to new and opposing ideas, and an exemplifies the Neurocrine culture of collegiality and teamwork Other duties as assigned Requirements: BS/BA degree in life sciences or related field and 8+ years of medical writing or related experience required. Experience leading an NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc) is highly preferred OR Master's degree in life sciences or related field and 6+ years of similar experience noted above OR PhD in life sciences or related field and 4+ years of similar experience noted above Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses Strong science background that enables the ability to interpret and communicate scientific and clinical trial data Broad understanding of the medical writing processes, procedures, and systems (eg DMS) Ability to provide constructive feedback as it relates to communicating and positioning nonclinical and clinical data Excellent understanding of the writing and regulatory process that enables streamlining of content and processes Experience leading NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc.) Anticipates business and industry issues; recommends relevant process / technical / service improvements Demonstrates broad expertise or unique knowledge Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Mentoring skills and ability to leads lower levels staff and/or indirect teams Excellent computer skills Excellent communications, problem-solving, analytical thinking skills Recognizes broader picture and longer-term impact on division/company Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Proven ability to lead cross-functional teams through the authoring process Excellent team player who can effectively navigate differing opinions and personalities Able to work well both independently and as part of a team Excellent project management skills, including managing simultaneous projects Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools #LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $153,800.00-$222,850.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development. As a strategic partner to senior clinical leadership, the incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions This role reports to the Director of Medical Writing Senior Medical Writer(s) and Medical Writer(s) will report to this role Main Responsibilities and Accountabilities Leads the Medical Writing contributions to assigned therapeutic area(s). Key accountabilities: Maintain a collaborative and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinial Safety Physicians to ensure understanding of Clinical Development strategy for the therapeutic area and the nature of medical writing services required to deliver on company objectives Critiques ability of product strategy (eg, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new or alternative arguments are needed. Leads cross-functional teams to develop a messaging strategy across a program of work (eg, building a clinical submission) The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines Forecasting, budgeting, resource planning and resource allocation. Managing (Senior) Medical Writer(s) within therapeutic area(s). Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work Drives and develops the messaging strategy within the therapeutic area to ensure effective communication underpins successful clinical development Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with intial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan). Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinial Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process. Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency. Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents. Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents. Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards. Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables. Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks. Responsible for continual improvement of in-house medical writing. Provides expert medical writing support to other CR&D and CSL groups where required In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs including forecasting, budgeting, resource planning and resource allocation Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship. Participates in vendor governance. Participant in bid defense, contract development, work alignment and / or operation meetings. Post-graduate qualifications (PhD or MD preferred) Experience A minimum of 8 years medical writing experience within the biopharmaceutical industry or a contract research organization. A minimum of 3 years in a supervisory role A comprehensive understanding of the clinical development process, including the documents that are required at each stage. A comprehensive understanding of medical writing processes, standards and issues. Demonstrated track record in cross-functional, multicultural and international clinical trial teams Excellent verbal, written and presentation skills. Mastery of the English language, with a comprehensive understanding of English grammar and punctuation Prior experience with submissions in Common Technical Document (CTD) format. Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and template IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

GENERAL SUMMARY The Sylvan Teacher is responsible for creating a positive personal learning experience for students by teaching students using Sylvan program materials. Using the program materials, the teacher creates balanced and robust learning experiences for students. The Sylvan Teacher evaluates student progress on each assignment, communicates this progress, and works with Center staff to ensure learning is personal for each student. ESSENTIAL JOB FUNCTIONS Prepares for each instructional session; Gathers and prepares materials as appropriate Greets students and initiates instruction to personally engage each student Instructs students according to the design of the Sylvan programs Manages students, tasks and time to create a balanced and robust instructional session Evaluates and records the progress of each student on their program assignment Uses praise and encouragement to ensure students are engaged and inspired to learn Motivates students with Sylvan tokens given for specific achievements according to the Sylvan instructional management standards Records and tracks tokens earned by students Manages the conclusion of each instructional session and manages the completion of learning log and transition activities; Supports procedures to ensure student safety and well-being Communicates specific student needs to Center staff Attends periodic staff meetings and completes ongoing training as needed Completes certification training on each Sylvan program taught to students KNOWLEDGE REQUIRED Language Arts and Study Skills Program Teachers: Four year degree or equivalent required State or provincial teaching credentials (current or expired) Minimum of one or two years of teaching experience preferred Knowledge of phonics and reading comprehension preferred for reading teachers Math Program Teachers: Four year degree required in a discipline requiring 3 or more years of college level math SAT/ACT, Test Prep, and Advanced Reading Skills Teachers: Four year degree or equivalent preferred Knowledge of general office equipment such as copiers, printers, and office phones Knowledge of tablet computers preferred SKILLS AND ABILITIES REQUIRED Proven ability to engage, motivate, and inspire students to learn Strong interpersonal and communication skills Proven ability to manage multiple tasks and be flexible Strong problem solving and customer service skills Strong team player The above statements are intended to describe the general nature and level of work being performed. They are not intended to be a complete list of all job responsibilities or skills, knowledge and abilities required.