Title: Document Specialist Location: India United States Full time The Document Specialist position is responsible for formatting, reviewing compiling, and processing regulatory documents (both Word and PDF) in support of electronic publishing activities with a focus on quality, accuracy, and efficiency providing publishing support to ProPharma clients. Essential Functions: - Directly supports electronic submission of regulatory documents / applications including IND, CTA, NDA, BLA, MAA, etc. through formatting, processing, and compilation of Word and PDF documents to the appropriate client specifications. - Formats and reviews Word documents in preparation for publishing, in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. - Performs document conversion to PDF, and formats and reviews PDF documents to specification (for eCTD compliance), including bookmarks, hyperlinks, keyword linking, document properties, etc., in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. - Compiles regulatory documents / reports, gathering all required documents, within all established timelines. - Publishes regulatory documents according to all relevant guidelines and specifications for eCTD submission, performing all relevant pre- and post-publishing quality review checks. - Prepares and transfers final documents for publishing, supporting client and internal team during submission preparation, routing documents for review and approval, where applicable. - Adheres to established regulatory standards / guidelines including but not limited to: ICH E3 / E6(R2) / M4, EU MDR / IVDR, Company standard operating procedures, and client standards instructions. - Supports multiple publishing activities / projects simultaneously and manages own workload, ensuring completion of all projects within established timelines, immediately escalating any issues. - Manages client expectations and interacts and communicates directly with clients to ensure accuracy and maintain timeline integrity. - Performs peer / quality review of documents processed by other team members as requested. - Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to document publishing. - Brings issues and potential concerns to line manager / client oversight manager's attention in a timely manner. - Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). - May occasionally be required to work outside of normal business hours to support client's needs. - Other duties as assigned. Key skills required: - Minimum 3 years of experience in document publishing and / or formatting. - Pharmaceutical / biotech industry experience (specifically, INDs / CTAs, NDAs / BLAs / MAAs) preferred. - Other professional and/or educational experience may contribute toward these minimum requirements, as determined on a case-by-case basis. - Fluency in English Other key attributes desired: - Extensive knowledge and mastery of Microsoft Word (advanced level formatting). - Extensive knowledge and experience with Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems (e.g., ISI Toolbox, Core Dossier). - Excellent problem-solving skills, including the ability to think outside the box. - Ability to work on multiple projects at a time. - Exceptional project management and communication skills with a high attention to detail and quality. - Ability to think proactively and take initiative, with a willingness to take on new challenges. - Ability to work independently and contact management team proactively when additional support and resources are needed. - Ability to work effectively in a collaborative team environment. - Ability to work within established working hours. - Demonstrates a growth mindset and positive outlook in all work activities. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: MedTech Sales Job Sub Function: Capital Sales -- MedTech (Commission) Job Category: Professional All Job Posting Locations: North Carolina (Any City) Job Description: Job Description We are searching for the best talent for Regional Technology Specialist to be in North Carolina. About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech As the Regional Technology Specialist, you will: Be an integral part of J&J MedTech Electrophysiology US Field Sales & Service group reporting to a New Technology Manager (NTM), and closely partnering with, the Regional Business Director (RBDs) and Territory Managers (TMs). Under the general direction of the manager and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, you will focus on: - Assessing and increasing the clinical competency development for the assigned workgroup's field organization, and assessing team members' clinical skills, identifying internal or external resources to fill training gaps and monitor/track improvement to a level of certification and beyond. - Launching new technologies; and have accountability for achieving geographically aligned business objectives. Through this support, they will be a strategic partner to implement emerging education related to new technologies, organizational directives and to quantifiably improve their workgroup's level of clinical competence. The end result should be that Electrophysiology personnel are recognized as best in industry for their commercial, technical and clinical competencies and that new technology is introduced flawlessly. - May also be accountable to provide technical and clinical product support to Electrophysiology (EP) physicians and laboratory staff for electrophysiology diagnostic and therapeutic catheters and systems to enable practitioners to perform advanced cardiac ablation procedures. - Build and maintain mutually beneficial relationships with physicians & EP laboratory staff in order to identify and foster interest in new products or product indications to grow and develop the company's product and technology utilization. - Partner with Territory Managers, Field Service Engineers and Field Management to ensure alignment and coordination of activities to meet business objectives. - Work in coordination with the NTM and Global Education & Training team to accurately assess the clinical skills of assigned electrophysiology clinical team members and establish a prioritized clinical development plan leading to continual growth and business goal attainment. - Facilitate the development of the assigned electrophysiology clinical team members to meet the requirements of the certification and ongoing clinical development process. - Develop & execute a workgroup-wide certification plan that brings 100% of the group to the targeted level and accurately assesses the clinical skills of assigned per diem clinical support and manages them through the per diem certification process. Measure, and is accountable, to quantifiable learning and growth in their assigned workgroup. - Partner with Sales and Service leaders to execute content for emerging and targeted areas of growth. Partner with various stakeholders including Sales, Marketing and Global Education and Training to execute continual education of all sales and clinical field personnel. - Provide expert clinical product and technical assistance and training to physicians and EP/IC Lab Staff on the effective use of electrophysiology systems and catheter equipment (e.g., The CARTO® System and all appropriate software modules) during case procedures within an assigned geography, and in a manner that leads to meeting and exceeding business goals. Educate assigned customers on all electrophysiology products to optimize effective usage by providing technical and clinical information and in-service training. Share best practices to increase value for customers.  - Use and coach aligned workgroups on consultative selling techniques to identify potential sales opportunities within the account. Create awareness of electrophysiology solutions and facilitates Territory Manager (TM) and Clinical Account Specialist (CAS) contact with the key decision makers to drive incremental business. - Drive collaboration and maintains consistent, open lines of communication across the assigned responsibilities with the local team/Pod (i.e. TM and other CAS), as well as the support team (i.e. other EP/Ultrasound CAS, FSE, RBD/KAM) and other internal and external partners. - Develop and share best practices with US Field Sales and Service colleagues and internal partners. - Develop and grow mutually beneficial customer relationships within and beyond the EP/IC lab, including, but not limited to physicians, nurses and technicians, clinical and hospital administrators and staff.  - Stay current on company products instructions for use (IFU), best practices and technical troubleshooting, as well as relevant scientific clinical literature and new product information. - Prioritize and appropriately respond to requests in a high-stress environment.  Maintain composure and problem-solving focus during stressful interactions. - Engage in diagnostic dialogue with multiple internal and external business partners and stakeholders.  Formulate solutions based on dialogue and input gained during session.  - Respond daily to requests by email and voicemail from customers, practitioners and partners.  Perform administrative work, including CAS Field Visit Letters, training summaries, account documentation, compliance training requirements, expense reporting, and Company system input. - As required, respond to requests for case support to customers for the operation and use of electrophysiology equipment.  Set appointments, present clinical and technical information, and be present to ensure optimal equipment usage. - Communicate with counterparts, supervisor, and business partners to ensure efficiency and open lines of communications. - Maintains Safe Fleet standards according to Company guidelines. - Communicate business related issues or opportunities to the next management level. - Ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. - Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. - Perform other duties assigned as needed. Required Qualifications: - A minimum of a bachelor's degree, or 5 years of relevant professional work experience. - Excellent oral (including group presentations) and written communication skills, as well as solid organizational and time management abilities. - Do you have a valid driver's license issued in the United States? - Must be willing and able to travel up to 70% overnight locally, regionally, and nationally.  Preferred Qualifications: - Certification in cardiology technology (E.g. IBHRE, RCES), for EP and clinical experience. - Managerial / supervisory experience.  - Live in the assigned geography. - Strong computer skills, including proficiency with Microsoft Office products Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time. Here’s what you can expect: - Application review: We’ll carefully review your CV to see how your skills and experience align with the role. - Getting to know you: If there’s a good match, you’ll be invited to complete a short-recorded video interview, giving you the chance to share more about yourself. If successful, a recruiter will also reach out by phone to walk you through the process and answer any questions. - Interviews with the team: If you move forward, you’ll meet with the hiring manager (and possibly others on the team) in one or two interview rounds, depending on the role. - Staying informed: We know waiting can be hard, so our recruitment team will keep you updated and make sure you know what to expect at each step. - Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these. At the end of the process, we’ll also invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPONA Required Skills: Preferred Skills: Brand Positioning Strategy, Communication, Competitive Landscape Analysis, Compliance Management, Customer Centricity, Customer Experience Management, Incentive Policy, Procedures, and Quotas, Industry Analysis, Market Opportunity Assessment, Problem Solving, Profit and Loss (P&L) Management, Project Management, Sales Prospecting, Strategic Sales Planning, Strategic Thinking, Sustainable Procurement, Vendor Selection

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: MedTech Sales Job Sub Function: Capital Sales -- MedTech (Commission) Job Category: Professional All Job Posting Locations: Virginia (Any City) Job Description: Job Description We are searching for the best talent for Regional Technology Specialist to be in Virginia. About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech As the Regional Technology Specialist, you will: Be an integral part of J&J MedTech Electrophysiology US Field Sales & Service group reporting to a New Technology Manager (NTM), and closely partnering with, the Regional Business Director (RBDs) and Territory Managers (TMs). Under the general direction of the manager and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, you will focus on: - Assessing and increasing the clinical competency development for the assigned workgroup's field organization, and assessing team members' clinical skills, identifying internal or external resources to fill training gaps and monitor/track improvement to a level of certification and beyond. - Launching new technologies; and have accountability for achieving geographically aligned business objectives. Through this support, they will be a strategic partner to implement emerging education related to new technologies, organizational directives and to quantifiably improve their workgroup's level of clinical competence. The end result should be that Electrophysiology personnel are recognized as best in industry for their commercial, technical and clinical competencies and that new technology is introduced flawlessly. - May also be accountable to provide technical and clinical product support to Electrophysiology (EP) physicians and laboratory staff for electrophysiology diagnostic and therapeutic catheters and systems to enable practitioners to perform advanced cardiac ablation procedures. - Build and maintain mutually beneficial relationships with physicians & EP laboratory staff in order to identify and foster interest in new products or product indications to grow and develop the company's product and technology utilization. - Partner with Territory Managers, Field Service Engineers and Field Management to ensure alignment and coordination of activities to meet business objectives. - Work in coordination with the NTM and Global Education & Training team to accurately assess the clinical skills of assigned electrophysiology clinical team members and establish a prioritized clinical development plan leading to continual growth and business goal attainment. - Facilitate the development of the assigned electrophysiology clinical team members to meet the requirements of the certification and ongoing clinical development process. - Develop & execute a workgroup-wide certification plan that brings 100% of the group to the targeted level and accurately assesses the clinical skills of assigned per diem clinical support and manages them through the per diem certification process. Measure, and is accountable, to quantifiable learning and growth in their assigned workgroup. - Partner with Sales and Service leaders to execute content for emerging and targeted areas of growth. Partner with various stakeholders including Sales, Marketing and Global Education and Training to execute continual education of all sales and clinical field personnel. - Provide expert clinical product and technical assistance and training to physicians and EP/IC Lab Staff on the effective use of electrophysiology systems and catheter equipment (e.g., The CARTO® System and all appropriate software modules) during case procedures within an assigned geography, and in a manner that leads to meeting and exceeding business goals. Educate assigned customers on all electrophysiology products to optimize effective usage by providing technical and clinical information and in-service training. Share best practices to increase value for customers.  - Use and coach aligned workgroups on consultative selling techniques to identify potential sales opportunities within the account. Create awareness of electrophysiology solutions and facilitates Territory Manager (TM) and Clinical Account Specialist (CAS) contact with the key decision makers to drive incremental business. - Drive collaboration and maintains consistent, open lines of communication across the assigned responsibilities with the local team/Pod (i.e. TM and other CAS), as well as the support team (i.e. other EP/Ultrasound CAS, FSE, RBD/KAM) and other internal and external partners. - Develop and share best practices with US Field Sales and Service colleagues and internal partners. - Develop and grow mutually beneficial customer relationships within and beyond the EP/IC lab, including, but not limited to physicians, nurses and technicians, clinical and hospital administrators and staff.  - Stay current on company products instructions for use (IFU), best practices and technical troubleshooting, as well as relevant scientific clinical literature and new product information. - Prioritize and appropriately respond to requests in a high-stress environment.  Maintain composure and problem-solving focus during stressful interactions. - Engage in diagnostic dialogue with multiple internal and external business partners and stakeholders.  Formulate solutions based on dialogue and input gained during session.  - Respond daily to requests by email and voicemail from customers, practitioners and partners.  Perform administrative work, including CAS Field Visit Letters, training summaries, account documentation, compliance training requirements, expense reporting, and Company system input. - As required, respond to requests for case support to customers for the operation and use of electrophysiology equipment.  Set appointments, present clinical and technical information, and be present to ensure optimal equipment usage. - Communicate with counterparts, supervisor, and business partners to ensure efficiency and open lines of communications. - Maintains Safe Fleet standards according to Company guidelines. - Communicate business related issues or opportunities to the next management level. - Ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. - Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. - Perform other duties assigned as needed. Required Qualifications: - A minimum of a bachelor's degree, or 5 years of relevant professional work experience. - Excellent oral (including group presentations) and written communication skills, as well as solid organizational and time management abilities. - Do you have a valid driver's license issued in the United States? - Must be willing and able to travel up to 70% overnight locally, regionally, and nationally.  Preferred Qualifications: - Certification in cardiology technology (E.g. IBHRE, RCES), for EP and clinical experience. - Managerial / supervisory experience.  - Live in the assigned geography. - Strong computer skills, including proficiency with Microsoft Office products Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time. Here’s what you can expect: - Application review: We’ll carefully review your CV to see how your skills and experience align with the role. - Getting to know you: If there’s a good match, you’ll be invited to complete a short-recorded video interview, giving you the chance to share more about yourself. If successful, a recruiter will also reach out by phone to walk you through the process and answer any questions. - Interviews with the team: If you move forward, you’ll meet with the hiring manager (and possibly others on the team) in one or two interview rounds, depending on the role. - Staying informed: We know waiting can be hard, so our recruitment team will keep you updated and make sure you know what to expect at each step. - Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these. At the end of the process, we’ll also invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPONA Required Skills: Preferred Skills: Brand Positioning Strategy, Communication, Competitive Landscape Analysis, Compliance Management, Customer Centricity, Customer Experience Management, Incentive Policy, Procedures, and Quotas, Industry Analysis, Market Opportunity Assessment, Problem Solving, Profit and Loss (P&L) Management, Project Management, Sales Prospecting, Strategic Sales Planning, Strategic Thinking, Sustainable Procurement, Vendor Selection

Required Qualifications (as evidenced by an attached resume): Bachelor's degree (foreign equivalent or higher). Previous experience teaching Math and/or Science to high school students. Preferred Qualifications: Master's degree (foreign equivalent or higher) in Education, Science, Engineering, or Math. NYS teaching certification. Brief Description of Duties: The STEP program at Stony Brook University provides academic enrichment and Regents preparation to economically disadvantaged and underrepresented high school students. We are committed to narrowing the achievement gap by providing rigorous, accessible, and real-world instruction that empowers students to excel in their upcoming NYS Regents Exams. We are seeking passionate licensed educators to lead virtual review sessions in subjects such as Geometry, Algebra 2/Trigonometry, Living Environment, Chemistry, and Physics. Responsibilities would include designing and implementing interactive virtual lessons; delivering rigorous, Regents-aligned curriculum; and taking on the added responsibility of training, supervising, and evaluating Collegiate CSTEP Teaching Interns who will assist with breakout rooms and individualized student support. Instructors would also be required to attend and participate in training and curriculum development sessions, assess student readiness for the Regents exams, and adjust instruction accordingly. Candidates must hold valid New York State teaching certification and have experience with virtual platforms such as Zoom or Google Classroom. - Designing and implementing interactive virtual lessons - Delivering rigorous, Regents-aligned curriculum - Training, supervising, and evaluating CSTEP Interns - Evaluate sessions in regard to STEP goals and objectives - Encourage students from STEP Partner Districts with distinct demographic profiles to pursue higher education - Other duties or projects as assigned Special Notes: The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research policies and procedures, sponsor guidelines and the availability of funding. FLSA Non Exempt position, eligible for the overtime provisions of the FLSA. The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU’s good faith and reasonable estimate of the range of possible compensation at the time of posting. For this position, we are unable to sponsor candidates for work visas. Evening and weekend work may be required at times. Resume/CV and cover letter should be included with the online application. Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws. If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at (631) 632-6280 or visit OEA. In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here. Visit our WHY WORK HERE page to learn about the total rewards we offer. SUNY Research Foundation: A Great Place to Work. #LI-TG1