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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.

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. The Senior Manager, Regulatory Writing is responsible for authoring regulatory documents, including but not limited to clinical study protocols, protocol amendments, clinical study reports (CSRs), clinical summaries, investigator’s brochures (IBs), pediatric documents, and regulatory authority briefing materials and responses. This individual will work independently with minimal oversight and in close collaboration with cross-functional teams to lead the development of these documents. All work must ensure scientific accuracy, alignment with study and submission objectives, compliance with standard operating procedures (SOPs), ICH/GCP and regulatory guidelines, and company goals. The Senior Manager will interpret and summarize complex regulatory data from a variety of sources in a concise, fit-for-purpose manner. This role requires strong attention to detail, critical thinking, and adherence to best writing practices. The Senior Manager will also lead and facilitate cross-functional meetings such as document kickoff meetings, data interpretation meetings, and comment resolution meetings. In addition, the role involves managing multiple complex writing projects, requiring excellent time management, problem-solving, and stakeholder engagement skills. The individual in this role will have demonstrated experience as a lead writer for a range of regulatory documents, including submissions, briefing materials, and responses to health authority questions. The role may also support other departmental Regulatory Writing activities as needed. Responsibilities Write, review, and edit clinical and regulatory documents such as clinical study protocols, CSRs, IBs, clinical summaries, and other documents as required for complex submissions (IND/NDA/BLA/MAA). In addition, provide support for health authority briefing documents, and responses to questions/requests for information, as needed. If a lead writer for assigned programs, serves as the primary point of contact for submission and project teams while acting as the lead author for complex documents while supporting document timelines and content strategy. May oversee additional writing and QC work performed by the vendors. For large, complex documents (e.g., CSRs), plan kickoff meetings, define overall timelines and lead authoring and comment resolution, from the initial draft through final approval. Arrange and conduct comment resolution/review meetings with cross-functional teams and depending on nature and complexity resolve document content issues independently or collaboratively (e.g. comments and questions arising from the writing/review process). Work with cross-functional stakeholder groups, including Clinical Research, Biometrics, Drug Safety, Regulatory, Clinical Pharmacology etc. as a significant contributor to set priorities for document preparation, collaborate on document content, and ensure scientific accuracy and alignment. Represent Regulatory Writing on project teams and advise on fit for purpose content and format requirements for various documents. Develop and drive timelines, and communicate writing process and timelines to team members. Provide status/updates of Regulatory Writing deliverables to management. Share and implement Regulatory Writing best practices to ensure efficiency and consistency across product teams. May contribute content to safety documents (e.g., DSURs, RMPs). May serve as a subject matter expert on systems and process initiatives including document management system implementations and updates to document development practices. Comply with established company policies and procedures, and industry and regulatory guidelines. Other duties as assigned. Qualifications BA/BS in one of the life sciences with a minimum of 8+ years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 5+ years of relevant regulatory/medical writing experience with a deep understanding of regulatory standards and data-driven documentation. Excellent communication skills both orally and in writing. Ability to work both independently and in cross-functional team environments with minimal supervision. Demonstrated ability to lead development of large/complex regulatory and clinical documents including but not limited to CSRs, module 2 summaries, and regulatory authority meeting briefing documents. Ability to engage and disseminate information among appropriate stakeholders for effective document preparation. Strong attention to detail with the ability to effectively write/summarize science-and data-driven content into clear, concise, and complete documents. Skilled in verifying data integrity, identifying errors and inconsistencies across various document types, and addressing them effectively. Ability to work effectively in a fast-paced environment with multiple high-priority projects. Ability to oversee consultants/contractors and serve as a liaison for project purposes. Excellent Project management skills. Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP). #LI-HYBRID Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $173,700.00 - $202,650.00 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com Please visit our website at: www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer

About Us: Impact Kids has been providing safe, fun, and meaningful enrichment programs for over 5 years, and today we serve students at public and private schools across the country. Students have a safe space to develop, learn, play, and most importantly, just be kids in our before, during, and after school programs! Who We Are Looking For: Looking for experienced individuals for teaching and instruction of writing for kids. Candidate must possess a high energy, positive approach with a genuine desire to impact young children’s lives through writing. The ideal candidate would be knowledgeable about writing and be passionate about teaching kids. This individual must provide constructive criticism, implement curriculum, and be a team player.  Also demonstrate outstanding communication skills with children and their parents, which include the ability to use clear, concise, and grammatically correct written and oral language in all aspects of professional interaction with students, their families, peers, the leadership team and the larger community. A Child abuse clearance and criminal checks are required. Experience Requirements: A Minimum of 2 years of previous experience working with children; examples include but are not limited to:  academic/athletic tutoring, camp counselor, and youth volunteer. Writing instructor/teaching experience (1 – 5 years minimum) required. Education Requirements: Bachelor’s degree (preferred but not required) Essential Job Responsibilities: The Writing Tutor is responsible for the supervision of students, giving writing instruction, providing a safe and fun learning environment, and serving as a positive role model for students. Implementing daily writing tutoring to students between the ages of 4 and 18 with different ability levels. 1 on 1 Tutoring to connect with individual students for a highly personalized learning experience while managing the group of students. Teach fundamental writing to promote skill development and proficiency. Group supervision of students with attention to: behavior and group management, health and safety, security, and personal and skill development. Ensure the safety of students and team members Organize and prepare daily plans in a fun and creative manner. Use effective classroom management skills to lead the activity and effectively create a fun environment where everyone feels included. Work effectively with fellow Activity Specialists and collaborate on daily responsibilities. Serve as a positive role model to students. Follow the Impact Kids Code of Conduct and maintain the Impact Kids look at all times. Exhibit Impact Kids Core Values at all times and adhere to all company policies. Have fun! Working Conditions and Physical Requirements: Be willing to travel. Ability to respond to emergency situations that may require running and climbing stairs. Good physical condition which enables candidate to execute all responsibilities associated with this position Powered by JazzHR