UNKNOWN

FEED

Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. The Associate Director serves as a subject matter expert in electronic submissions (eCTD), publishing systems, and regulatory operation infrastructure, driving submission excellence, process optimization, compliance readiness, and system innovation across the Regulatory organization.

YEAR

<div class="content-intro">Arrowhead Pharmaceuticals, Inc. (Nasdaq:  ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI.  Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. </div>The PositionThe Associate Director, Regulatory Operations, is responsible for strategic and operational leadership of complex submissions, publishing, and regulatory information management systems. This role ensures the delivery of high-quality, compliant regulatory dossiers. This role ensures the delivery of high-quality, compliant regulatory dossier to FDA and global health authorities.The Associate Director serves as a subject matter expert in electronic submissions (eCTD), publishing systems, and regulatory operation infrastructure, driving submission excellence, process optimization, compliance readiness, and system innovation across the Regulatory organization.Responsibilities<ul><li>Provide operational leadership and oversight for global regulatory submissions, ensuring compliance with applicable regional regulations and technical requirements. Oversee preparation, publishing, quality control, and transmission of electronic submissions (eCTD) for INDs, NDAs, CTAs, MAAs, and post-approval submissions</li><li>Ensure submissions deliverables meet health authority formatting, validation, and technical standards</li><li>Own and oversee regulatory publishing systems and regulatory information management systems (e.g., Veeva RIM), ensuring system integrity, compliance, and optimization.</li><li>Establish and maintain standardized processes for document formatting, publishing workflows, submission validation, and archiving.</li><li>Oversee regulatory archiving and document retention practices in accordance with global regulatory requirements.</li><li>Evaluate and implement system enhancements, automation, and emerging technologies to improve efficiency and compliance.</li><li>Develop and maintain SOPs and work instructions related to regulatory operations and publishing.</li><li>Serve as the regulatory operations expert to advise teams on submission standards, timelines for technical preparation, and health authority expectations.</li><li>Partner closely with Medical Writing, Regulatory Affairs, Quality, Clinical Operations, and external partners/vendors to ensure clarify of submissions requirements and operational readiness.</li><li>Perform quality control checks and work with the subject matter expert to address findings</li><li>Identify and resolve formatting, technical, and compliance issues related to publishing manners in collaboration with subject matter experts</li><li>Manage Arrowhead's archiving and document retention processes, in accordance with regulations and inspection readiness.</li></ul>Requirements<ul><li>Bachelor's degree in life sciences, computer science, or related science discipline</li><li>8+ years of relevant experience in pharmaceutical, biotechnology, or life sciences industry, including leadership experience in Regulatory Affairs Operations and Publishing</li><li>Deep expertise in electronic submission requirements (eCTD and regional variations)</li><li>Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools)</li><li>Experience preparing and publishing high-quality electronic regulatory dossiers with major health authorities</li><li>Demonstrated understanding of regulatory systems from both business process and end-user perspectives.</li><li>Ability to maintain highest degree of professionalism, integrity and diplomacy</li></ul>Preferred<ul><li>Experience with regulatory information management systems (e.g., Veeva RIM).</li><li>Knowledgeable in emerging technologies, including AI applications in regulatory operations.</li><li>Ability to serve as senior publishing SME and technical escalation point</li><li>Experience supporting global inspection readiness.</li></ul><div class="content-pay-transparency"><div class="title" style="font-weight:600;padding-top:8px">California pay range </div><div class="pay-range">$180,000—$210,000 USD</div></div><div class="content-conclusion">Arrowhead provides competitive salaries and an excellent benefit package.   All applicants must have authorization to work in the US for a company.   <a href="https://arrowheadpharma.com/wp-content/uploads/2023/09/Arrowhead-California-Applicant-Privacy-Policy.pdf" rel="nofollow noopener noreferrer" target="_blank">California Applicant Privacy Policy</a></div>

Arrowhead Pharmaceuticals

Associate Director, Global Regulatory Operations (Regulatory Submissions and Publishing)

GreenHouseAPI

ADAPTED_NOW

Under general supervision, the Technical Publications Specialist researches, collects, and analyzes complex technical information from engineering drawings, system specifications, software documentation, test procedures, and subject matter experts. + Experience with S1000M specification for maintenance planning and analysis, including maintenance task development, LSA integration, and maintenance data module structures.

53569BR Company: General Atomics Aeronautical Systems Job Summary: General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. Under general supervision, the Technical Publications Specialist researches, collects, and analyzes complex technical information from engineering drawings, system specifications, software documentation, test procedures, and subject matter experts. Uses this data to develop detailed operators, maintenance, and troubleshooting procedures, checklists, technical specifications, alert bulletins, training materials, and other technical reports. May reference logistics data as needed to ensure technical content is accurate and complete. This role applies structured authoring using the S1000D specification and CSDB workflows, incorporates controlled language standards such as ASD-STE100 Simplified Technical English, and ensures compliance with applicable MIL-STD documentation requirements DUTIES AND RESPONSIBILITIES: + Research, collect, and analyze technical information from engineering drawings, system specifications, software documentation, test procedures, and subject matter experts. + Develop and document operators, maintenance, and troubleshooting procedures, checklists, technical specifications, alert bulletins, training materials, and other reports. + Reference logistics data as needed to ensure technical content supports operational and maintenance procedures. + Author, edit, and manage structured S1000D data modules within CSDB environments, applying information codes, metadata tagging, publication modules, and content reuse strategies. + Apply ASD-STE100 controlled language principles to improve clarity, consistency, and readability of documentation. + Ensure all technical publications comply with S1000D, MIL-STD and other applicable standards. + Perform technical editing and validation to ensure accuracy, completeness, and compliance with program requirements. + Coordinate technical reviews and approvals with engineering, configuration management, and program management stakeholders. + Support the development and improvement of documentation processes aligned with S1000D best practices. + May lead or coordinate small- to medium-sized documentation teams to meet quality, schedule, and contractual requirements. + May serve as a technical publications point of contact, collaborating with integrated product teams (IPTs), engineering, and customer representatives. + Mentor junior technical writers in S1000D structured authoring, CSDB workflows, and ASD-STE100 standards. + Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating practices and procedures. + Additional Functions Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job ID#: 53569BR Job Category: Product Support Travel Percentage Required: 0% - 25% Full-Time/Part-Time: Full-Time Salary State: California Clearance Level: Secret Pay Range Low: 73,700 City: Poway Clearance Required?: Desired Pay Range High: 128,780 Recruitment Posting Title: Technical Writer and Editor Job Qualifications: + Typically requires education or formal training equivalent to the completion of an associate's degree in a related discipline and six or more years progressive experience in a technical field. May substitute equivalent professional experience in lieu of education/training. + Degree in Technical Communication, Engineering, English, Information Systems, or related is preferred. + Expertise with structured technical publications using the S1000D specification, including data module authoring, publication module structures, CSDB workflows, metadata tagging, content reuse, configuration management, and XML-based structured authoring. + Experience with S1000M specification for maintenance planning and analysis, including maintenance task development, LSA integration, and maintenance data module structures. + Working knowledge of GEIA-STD-0007 (GEIA 7000) for Logistics Product Data and its application to integrated logistics support documentation. + Working knowledge of MIL-STD documentation requirements for DoD programs. + Knowledge and practical application of ASD-STE100 Simplified Technical English for clear, consistent documentation. + Experience with technical publication tools: + PTC Arbortext Editor + Adobe FrameMaker + SDL Contenta Publishing Suite + Cortona3D RapidAuthor + XML editing and publishing tools + Strong analytical, organizational, and communication skills. + Ability to work both independently and lead in a team environment is essential as is the ability to work extended hours and travel as required. + Ability to obtain and maintain a DoD Security Clearance is required. US Citizenship Required?: Yes Experience Level: Mid-Level (3-7 years) Relocation Assistance Provided?: No Workstyle: Hybrid General Atomics is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, religious creed, ancestry, gender, pregnancy, sex, sexual orientation, transitioning status, gender identity, gender expression, national origin, age, genetic information, military and veteran status, marital status, medical condition, mental disability, physical disability, or any other basis protected by local, state, or federal law. In accordance with applicable federal law, General Atomics takes affirmative action to employ and advance the employment of qualified protected veterans and individuals with disabilities. We also prohibit compensation discrimination under all applicable laws. U.S. Citizenship is required for certain positions. To learn more, please review the EEOC’s "Know Your Rights: Workplace Discrimination is Illegal" poster.

General Atomics

Technical Writer/Editor III

Adobe FrameMaker

Affirmative Action

Aircraft Piloting

Analysis Skills

Arbortext Editor

Best Practices

Communication Skills

Configuration Management

Contract Requirements

Data Structures

DoD Clearance

Documentation

Editing

Engineering Drawing

English Language

Federal Laws and Regulations

Genetics

Information Technology & Information Systems

Logistics

Maintain Compliance

Medical Conditions

Mentoring

Metadata

Military

Military/DoD Standards

Operations Processes

Organizational Skills

Process Improvement

Product Support

Project/Program Management

Publications

Publishing Software

Regulations

Regulatory Compliance

SDL (Specification and Description Language)

Safety/Work Safety

Security Clearance

Software Specification

Software Testing

Support Documentation

Surveillance

Team Lead/Manager

Technical Analysis

Technical Editing

Technical Leadership

Technical Publications

Technical Research

Technical Support

Technical Writing

Testing

Time Management

United States Citizen

United States Department of Defense (DoD)

Willing to Travel

Writing Skills

XML (EXtensible Markup Language)

General Atomics and Affiliated Companies

Under general supervision, this role will analyze complex technical information from engineering drawings, system specifications, software documentation, test procedures, and subject matter experts. + Experience with S1000M specification for maintenance planning and analysis, including maintenance task development, LSA integration, and maintenance data module structure is desired.

52600BR Company: General Atomics Aeronautical Systems Job Summary: General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. Under general supervision, this role will analyze complex technical information from engineering drawings, system specifications, software documentation, test procedures, and subject matter experts. Utilizing this data to develop detailed operators, maintenance, and troubleshooting procedures, checklists, technical specifications, alert bulletins, training materials, and other technical reports. May reference logistics data as needed to ensure technical content is accurate and complete. This role applies structured authoring using the S1000D specification and CSDB workflows, incorporates controlled language standards such as ASD-STE100 Simplified Technical English, and ensures compliance with applicable MIL-STD documentation requirements. DUTIES AND RESPONSIBILITIES: + Research, collect, and analyze technical information from engineering drawings, system specifications, software documentation, test procedures, and subject matter experts. + Develop and document operators, maintenance, and troubleshooting procedures, checklists, technical specifications, alert bulletins, training materials, and other reports. + Utilize logistics data as needed to ensure technical content supports operational and maintenance procedures. + Author, edit, and manage structured S1000D data modules within CSDB environments, applying information codes, metadata tagging, publication modules, and content reuse strategies. + Apply ASD-STE100 controlled language principles to improve clarity, consistency, and readability of documentation. + Ensure all technical publications comply with S1000D, MIL-STD and other applicable standards. + Perform technical editing and validation to ensure accuracy, completeness, and compliance with program requirements. + May assist with coordinating technical reviews and approvals with engineering, configuration management, and program management stakeholders. + May support the development and improvement of documentation processes aligned with S1000D best practices. + May collaborate with integrated product teams (IPTs), engineering, and customer representatives as needed. + Assist senior technical writers with complex documentation projects and learn advanced S1000D techniques. + Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company. + Expected to work in a safe manner in accordance with established operating practices and procedures. + Additional Functions: Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job ID#: 52600BR Job Category: Product Support Travel Percentage Required: 0% - 25% Full-Time/Part-Time: Full-Time Salary State: California Pay Range Low: 56,820 City: Poway Clearance Required?: No Pay Range High: 96,015 Recruitment Posting Title: Technical Writer and Editor Job Qualifications: + ​​​​​Typically requires education or formal training equivalent to the completion of an associate's degree in a related discipline and three or more years progressive experience in a technical field. May substitute equivalent professional experience in lieu of education/training. + Degree in Technical Communication, Engineering, English, Information Systems, or a related field preferred. + Aerospace industry experience is desired. + S1000D experience is desired; willingness to learn structured authoring methodologies is essential. + Experience with S1000M specification for maintenance planning and analysis, including maintenance task development, LSA integration, and maintenance data module structure is desired. + Working knowledge of GEIA-STD-0007 (GEIA 7000) for Logistics Product Data and its application to integrated logistics support documentation is desired. + Familiarity with MIL-STD documentation requirements for DoD programs is preferred. + Knowledge of ASD-STE100 Simplified Technical English for clear, consistent documentation. + Experience with: + PTC Arbortext Editor + Adobe FrameMaker + SDL Contenta Publishing Suite + Cortona3D RapidAuthor + XML editing and publishing tools + Strong analytical, organizational, and communication skills. + Ability to work both independently and collaboratively in a team environment is essential as is the ability to work extended hours and travel as required. + Ability to obtain and maintain a DoD Security Clearance is required. US Citizenship Required?: Yes Experience Level: Mid-Level (3-7 years) Relocation Assistance Provided?: No Workstyle: Hybrid General Atomics is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, religious creed, ancestry, gender, pregnancy, sex, sexual orientation, transitioning status, gender identity, gender expression, national origin, age, genetic information, military and veteran status, marital status, medical condition, mental disability, physical disability, or any other basis protected by local, state, or federal law. In accordance with applicable federal law, General Atomics takes affirmative action to employ and advance the employment of qualified protected veterans and individuals with disabilities. We also prohibit compensation discrimination under all applicable laws. U.S. Citizenship is required for certain positions. To learn more, please review the EEOC’s "Know Your Rights: Workplace Discrimination is Illegal" poster.

Technical Writer/Editor II

Aerospace and Defense

OTHER

This position is an excellent fit if you are fluent in both Spanish and English, love helping families, have the best experience in soccer, love taking care of people, are highly organized, are future-oriented, and enjoy people. The bi-lingual Customer Service / Administrative duties include answering phones and emails of customer registrations and inquiries, running company reports, and publishing the future seasons of Soccer Shots on our online platform.

Who We Are:Soccer Shots East County San Diego, LLC, is a team of passionate individuals who love what they do and work with children aged 18 months - 10 years old.  We are on a mission to positively impact our San Diego community through the love of soccer. Our high-quality and high energy soccer classes run weekly throughout San Diego County. We proudly serve and partner with Preschools, Elementary schools, and Public Parks; from Imperial Beach to Escondido we serve thousands of families every week. We care deeply about our brand, our teammates, and our students as we represent San Diego and soccer development. Summary:Soccer Shots East County San Diego, LLC is seeking an experienced, bi-lingual Customer Service / Administrative Professional to support our families, children, and coaches both in the office and on the field. This position requires innovative problem-solving skills, excellent verbal and written communication skills in a fast-paced environment. The bi-lingual Customer Service / Administrative duties include answering phones and emails of customer registrations and inquiries, running company reports, and publishing the future seasons of Soccer Shots on our online platform. This position is an excellent fit if you are fluent in both Spanish and English, love helping families, have the best experience in soccer, love taking care of people, are highly organized,  are future-oriented, and enjoy people.  You also enjoy creating and organizing spreadsheets, and want to learn new programs/tech platforms.Job Summary: Duties & Responsibilities (not limited to)  <ol><li>Accountable for a first class customer experience the primary Soccer Shots East County email and phone lines,  representing the company in all correspondence verbally and written in both English and Spanish.</li><li>Sell and advocate for the program and enroll families online and over the phone</li><li>Problem solve customer accounts and communicate clearly the results </li><li>Upload seasons on the tech platforms </li><li>Accountable for declines collections</li><li>Maintains office </li><li>Maintain and order office supplies </li></ol>Requirements: <ul><li>Morning to mid-afternoon availability, with Wednesday and Saturdays being mandatory</li><li>Must complete on field training to understand our products </li><li>1 year of customer service experience </li><li>Bilingual in Spanish required</li><li>Minimum of a 1-year commitment </li><li>Reliable car & driver's license </li><li>Ability to provide a cleared background check </li></ul>Benefits:<ul><li>401K match within 90 days</li><li>Quarterly coach performance bonus</li><li>4 weeks off per year</li><li>$30/month cell phone reimbursement </li></ul>Hours and Pay: <ul><li>Part-time position (20-28 hours per week)</li><li>Starting rate of $18-$22/hr DOE for administrative shifts, $17.25/hr for training</li></ul>Opportunities for advancement include an annual raise and bonus for team members who are interested in expanding their skill sets and education.  Could also be promoted to full time for the right candidate.

Soccer Shots East and South SD

Part-time Customer Service/Admin Professional

Administrative Skills

Background Investigation

Cellular Telephone

Coaching

Credit and Collections

Customer Experience

Customer Support/Service

Driver's License

Multilingual

Order Supplies

Presentation/Verbal Skills

Problem Solving Skills

Publishing

Reimbursement

Resolve Customer Issues

Sales

Soccer

Spanish Language

Spreadsheets

Telephone Skills

United States Department of Energy (DOE)

BreezyHR

Publishing jobs in Coronado, CA - find them here! Apply today to the top opportunities near you.

Top Publishing Jobs in Coronado, CA | Monster

Publishing Jobs in Coronado, CA

Jobs

Resume Resources

Get noticed by top employers!

Publishing Jobs in Coronado, CA

Jobs

Associate Director, Global Regulatory Operations (Regulatory Submissions and Publishing)Arrowhead Pharmaceuticals

Technical Writer/Editor IIIGeneral Atomics

Technical Writer/Editor IIGeneral Atomics

Part-time Customer Service/Admin ProfessionalSoccer Shots East and South SD

Resume Resources