Submit The Documentation Specified Jobs in Other US Location

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AI Application Developer (Full-Stack)

Company: TekRevol

Location: Other US Location

Posted Jan 27, 2025

Tekrevol is a global mobile app development company that provides businesses with reliable technological solutions. They aim to help businesses achieve sustainable growth and scalability. They are currently seeking a skilled AI Application Developer to design and develop AI-powered applications for web and mobile platforms. The role involves leveraging prebuilt AI tools, APIs, and custom solutions. Key responsibilities include designing end-to-end applications, building AI-powered features, developing intuitive user interfaces, and ensuring seamless experiences across devices. The ideal candidate should have strong experience in full-stack development, proficiency in backend and frontend technologies, and familiarity with AI tools and APIs.

Data Governance Manager

Company: Takeda

Location: Other US Location

Posted Jan 27, 2025

Takeda, a global pharmaceutical company, is inviting applications for a role in its Innovation Capability Center (ICC) in Bengaluru, India. The role involves optimizing data efficiency and quality, ensuring compliance with global data governance policies, and improving data trust across domains. The successful candidate will have a degree in Computer Science or Information Systems with at least 7 years of relevant experience. They should be familiar with data governance concepts, Collibra, GDPR, and various databases and tools. Takeda offers competitive benefits including a performance bonus, flexible work environment, comprehensive healthcare, and learning platforms. The company is committed to digital transformation and improving patients' lives.

Cyber Transformation

Company: PA Consulting

Location: Other US Location

Posted Jan 27, 2025

PA is an innovation and transformation consultancy seeking a Cyber Transformation Consultant. The role involves collaborating with clients to shape cybersecurity strategies, guiding transitions to new business models, and contributing to resolving cybersecurity issues. PA offers flexible working, extensive benefits, and a commitment to diversity and inclusion. The ideal candidate will have a proven track record in cybersecurity, project management, and business development.

Associate Director, Patient Advocacy & Communications, Japan Oncology Business Unit / 日本オンコロジー事業部 ペイシェントアドボカシー&コミュニケーション部 主席部員

Company: Takeda

Location: Other US Location

Posted Jan 27, 2025

The Associate Director of Patient Advocacy and Communication for Takeda's Japan Oncology Business Unit (JOBU) is responsible for establishing and executing the communication and patient advocacy strategy. This role involves driving external and internal communications, managing agency partners and budgets, designing patient advocacy programs, and developing compelling materials for external communications. The ideal candidate should have a BA/BS degree, at least 5+ years of experience in corporate communications, media relations, and patient advocacy, and flawless Japanese language skills. Strong interpersonal skills, enterprise strategic thinking, and a commitment to patient-centricity are essential. The position requires reasonable domestic/international travel and a hybrid working style.

Software Tester

Company: Takeda

Location: Other US Location

Posted Jan 27, 2025

Takeda is offering a Software Tester position in Bengaluru, India. The role involves designing and executing software tests, identifying product risks, and collaborating with various stakeholders. The ideal candidate should have a Bachelor's degree, 2+ years of relevant experience, and proficiency in English. Takeda is committed to creating an inclusive workplace and offers competitive compensation, flexible work environment, comprehensive healthcare insurance, and various learning platforms. The company is leading a digital revolution and improving the lives of millions of patients.

JT085 - SR. AUTOMATION ENGINEER

Company: Quality Consulting Group

Location: Other US Location

Posted Jan 27, 2025

Quality Consulting Group, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is seeking a talented, motivated individual to join their team. The role involves working with an enthusiastic team in a world-class manufacturing industry in Puerto Rico and the USA. Responsibilities include working with automation and supporting MES implementation, providing technical engineering support, recommending equipment and process modifications, integrating equipment and material capabilities, reviewing product development requirements, interacting with product design and development personnel, leading innovation development, developing manufacturing processes, ensuring compliance with regulations, and managing supplier change requests. Qualifications include a Bachelor's degree in engineering, expertise in automation and MES implementation, project management experience, advanced automation skills, process validation and computer software validation knowledge, equipment validation, network support, and availability for 1st shift.

Talent Acquisition Specialist

Company: Quality Consulting Group

Location: Other US Location

Posted Jan 27, 2025

Quality Consulting Group, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is seeking a talented, highly motivated, and enthusiastic individual to join their team. The role involves working with a highly enthusiastic team in a world-class manufacturing industry in Puerto Rico. Responsibilities include recruiting, interviewing, and facilitating the hiring of qualified job applicants, working closely with hiring managers, scheduling pre-employment tests, creating new-hire onboarding programs, determining selection criteria, sourcing applicants, creating job descriptions, and managing high-volume requests in a fast-paced environment.

Program Manager (SAP Master Data Management)

Company: Mobica

Location: Other US Location

Posted Jan 27, 2025

Mobica is a global software services company with offices in Europe and the USA. They partner with businesses across various industries, providing engineering expertise across the entire technology stack. Mobica empowers its employees to develop their skills and advance their careers. They prioritize ideas over hierarchy and biases, fostering an environment of open communication and equal opportunities. Mobica offers flexible working hours, training programs, and a supportive multicultural environment. They are currently seeking a highly experienced Program Manager with 15 to 20 years of experience in program management and a strong understanding of Master Data Management (MDM). The ideal candidate will lead various projects, ensure timely delivery and client satisfaction, and manage project budgets and resources effectively.

Software Test Engineer

Company: Takeda

Location: Other US Location

Posted Jan 27, 2025

Takeda is seeking a Software Test Engineer to join their ICC in Bengaluru. The role involves using technical and teamwork skills, knowledge of testing and test automation, DevSecOps tools, and methods to deploy and improve solutions. The candidate will align with testers, developers, engineers, analysts, scrum masters, and delivery managers. Responsibilities include reviewing user stories, evaluating acceptance criteria, creating test approaches, and running diverse sets of tests. The ideal candidate should have a Bachelor's degree, 4+ years of relevant experience, and expertise in GxP validated software solutions, Agile methodologies, and testing in the cloud. Takeda offers competitive compensation, flexible work environment, comprehensive healthcare insurance, and diverse learning platforms.

JT443 - SR. DESIGN AUTOMATION ENGINEER

Company: Quality Consulting Group

Location: Other US Location

Posted Jan 27, 2025

Quality Consulting Group, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is seeking a talented, highly motivated, and enthusiastic individual to join their team. The role involves working with a highly enthusiastic team in a world-class manufacturing industry in Puerto Rico and the USA. The responsibilities include developing and applying computer-aided design (CAD) software engineering methods, assessing architecture and hardware limitations, planning technical projects, defining new approaches for CAD software, and developing routines and utility programs. The qualifications required are a Bachelor's Degree in Engineering, four years of previous experience in the Medical Device or Pharmaceutical Industry, mid-level Control Systems Engineering experience, knowledge of Allen Bradley PLC, and experience with databases and PC applications. The ideal candidate should also have skills in automation, control engineering, machine integration, and be available for the 1st shift.

System Engineer / Feature Owner

Company: Mobica

Location: Other US Location

Posted Jan 27, 2025

Mobica is a global company offering engineering expertise across the technology stack. They empower employees, prioritize ideas over hierarchy, and foster a safe, inclusive environment. They are seeking an experienced System Engineer Feature Owner for ADAS Interior or Parking systems, with a competitive salary package and opportunities for professional growth. The role involves creating technical documentation, aligning and delivering features, and collaborating with cross-functional teams.

Sr Associate EH&S

Company: PharmaLex

Location: Other US Location

Posted Jan 27, 2025

PharmaLex is a globally recognized consulting firm in the healthcare industry, offering professional growth and a collaborative work environment. They are seeking candidates with a Master's or Bachelor's degree and relevant experience in Process Safety, PSM, and related fields. The role involves managing EH&S programs, ensuring regulatory compliance, designing training programs, and supporting operations. PharmaLex is an Equal Opportunity Employer.

Frequently Asked Questions

What are typical salary ranges by seniority in Submit Docs Spec roles?
Entry‑level Documentation Specialists earn $55,000–$70,000 annually. Mid‑level Coordinators and Technical Writers command $75,000–$95,000, while senior Regulatory Affairs Managers and Compliance Directors often reach $110,000–$140,000, depending on industry and geographic location.
Which skills and certifications are required?
Key skills include eCTD submission, ISO 9001/13485 documentation, GxP audit readiness, MasterControl or Sparta compliance software, and strong technical writing. Certifications such as Certified Regulatory Affairs Professional (CRA), Certified Quality Auditor (CQA), ISO 9001 Lead Auditor, and Six Sigma Green/Black Belt give candidates a competitive edge.
Is remote work available for Submit Docs Spec positions?
Yes, many employers support fully remote or hybrid models for documentation specialists and regulatory coordinators. Remote roles often rely on secure cloud platforms (e.g., SharePoint, Confluence, MasterControl) and virtual audit tools to maintain compliance.
What career progression paths exist?
Typical progression starts with Documentation Specialist → Regulatory Affairs Coordinator → Technical Writer → Regulatory Affairs Manager → Director of Compliance or Regulatory Affairs. Advancement often requires additional certifications and proven success managing multi‑regulatory submissions.
What are current industry trends affecting Submit Docs Spec roles?
Trends include AI‑driven document review for faster submission cycles, blockchain for immutable audit trails, regulatory sandboxes for digital health and medical devices, and increased focus on data privacy regulations like GDPR and CCPA. Professionals who stay current with these technologies will command higher salaries.

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