Technical writer jobs in Bethlehem, PA - 20 jobs

Job Title: Medical Writer Duration: 12+ Months Hybrid-2-3days/week Required Qualifications: Bachelor's degree/Master's degree with minimum 2 years of relevant experience in life sciences and process- and systems-related coordination PharmD or PhD preferred. Prior experience in Medical Affairs and/or medical content development preferred. Required Skills & Experience Experience partnering with business stakeholders across geographies, therapy areas, and functions to meet business needs in a timely and compliant manner Experience working independently to design and produce slide decks within an easy-to-navigate framework that supports stakeholder use with external customers Attention to detail, excellent communication skills, and the ability to work independently, escalating risks and issues as appropriate Demonstrated success in a fast-paced environment, with the ability to learn on the fly while understanding and solving new problems that require a high level of independent judgement and initiative Ability to identify the most efficient and effective way to implement new solution Proven ability to innovate and think non-traditionally Strong business acumen and ability to judge whether ideas can lead to compliant and value-adding customer solutions Excellent verbal and written communication to technical and non-technical audiences of various levels within the organization Outstanding presentation and facilitation skills Strong leadership skills and proven ability to influence without authority Good interpersonal and networking skills Curiosity and willingness to constantly challenge the status quo Preferred: Experience working at an affiliate, regional, and/or global level. Our team is responsible for creating external tools and resources for scientific exchange and in response to medical information inquiries. Software: MS PowerPoint, MS Excel, MS Word, Veeva Vault MedComms (Nice to have). Key skills: Medical Content writing experience. Medical affair or medical writing background. TA-Oncology Responsibilities Medical Writer Contractor, Global Scientific and Value Content reports to the GSVC Team Lead and focuses on several key functions within the GSVC Team. This role directly supports the GSVC Team in developing resources (e.g., slide decks, Medical Information Letters [MILs], Verbal Response Documents [VRDs]) for use by the Field Medical Organization and Global Medical Information Staff, among other responsibilities. This role participates in transformational initiatives in the fast-paced and dynamic environment of Value & Implementation Global Medical and Value Capabilities (V&I GMVC). The Medical Writer Contractor is responsible for the following functions and activities: GSVC Creation and maintenance: With guidance from senior GSVC colleagues, develops and maintains GSVC resources in alignment with the GSVC Annual plans for GMSA Field Medical and Global Medical Information staff. Reviews GSVC materials to ensure they are relevant, scientifically accurate, and consistent with cited appropriate scientific literature, internal scientific information, and Company values and standards. Quality/Compliance: Critically analyzes and evaluates the rendering, display, and presentation of scientific and therapeutic data for use by internal stakeholders to respond to Medical Information Requests (MIRs). Innovative GSVC Practices and Procedures: Supports creative solutions for communicating GSC in multiple formats based on internal and external customer needs. Supports innovative design, consultation, and development for infographics or other digital media used for in the development of GSVC content based on internal and external customer needs. Serves as an advocate for changing customer needs for GSVC, particularly for GMSA Field Medical and Global Medical Information (GMI) staff. Leads their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality work. Influences, partners and collaborates with other colleagues within the GSVC team. Collaborates effectively with peers and stakeholders to offer a new perspective on existing solutions while offering new innovations for the organization and communication of scientific content for GMSA Field Medical and GMI staff. Evaluates new technologies to best support GSVC organization needs.

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description JOB TITLE:- Technical Writer LOCATION:- Raritan, NJ DURATION:- 06+ MONTHS (with possible extension) JOB OVERVIEW As part of the Portfolio Management Office within the AS Operations and Continuous Process Improvement organization, the Content Manager will curate and write content and communications to support key AS PMO programs and initiatives. This includes but not limited to the AS Portfolio Playbook and AS Service Catalog. Additional content to author includes reference guides and knowledge articles for AS PMO processes and tools. This role will function as a member of AS Portfolio Management Office and will be based in Raritan, New Jersey. Specific responsibilities include: Lead the development of the AS Portfolio Playbook, which will educate AS employees regarding key AS Portfolio Processes. The AS Portfolio Playbook content will be developed and continually improved throughout 2016, and the candidate will lead development and refinement of content. This includes partnering with various Portfolio Managers and stakeholders to create the content. Lead the development of content within the AS Service Catalog content, which enables AS customers to review examples of successful AS service engagements and read service descriptions. This includes partnering with various service owners to create customer-friendly content, and managing the drafting, review, and publication of the content in the catalog application. In addition to writing content, partnering with Service Owners to create customer-friendly service descriptions may provide opportunities to influence the strategy and design of services. The candidate will organize additional content and communications for the AS PMO. This includes the PMO Newsletter, Best Practice Documentation, and Process Reference Guides. The candidate will need to collaborate with team members and stakeholders to collect, organize, curate, and publish content. Qualifications / Skill Requirements: College degree in journalism, communications, or related discipline, or equivalent combination of education and experience required Strong verbal communication and writing skills required Ability to conduct independent research required Excellent attention to detail and proofreading skills to ensure accurate, error-free work High level of computer literacy and knowledge, including Microsoft Office products Ability to work under pressure, meet deadlines, and take critiques as needed Ability to understand the IT operational model and PMO processes of demand, financial, resource, benefit and service management. Excellent oral communications and interpersonal skills Prior experience with Pharmaceutical and Application Services preferred Additional Information Thanks & Regards, Shipra Chauhan | Team Recruitment | *************

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Technical Writers is the frequent open position in Johnson & Johnson. Please share below the details and your updated resume with us so that I would be able to submit you first compare to other candidates in order to get the in -personal interview request from the company. I would like to mention that Johnson & Johnson has fastest interview process, as per our multiple year of experience, they moves very fast with the in - personal and offer. We have placed so many candidates, those we have submitted in an hours when the position comes in. Take some smart step and get the job in one of the leading healthcare company - Johnson & Johnson. Please provide the below details Total Experience - Expected Rate - Current Rate - Visa Status - DOB( Just Date and month is require for submission purpose ) - Available for in person - Available to Join - Location - Work Status - Qualification- In considering candidates, time is of essence so please respond ASAP. Additional Information Contact- Tel: (732) 549 2030 x 210 Sweta Verma

We are seeking an experienced Technical Writer with a strong background in defense contracting, aerospace, or other related technical fields. The ideal candidate will be responsible for creating, editing, and maintaining technical documentation that meets industry standards and supports the needs of both internal and external stakeholders. This role requires exceptional attention to detail, technical acumen, and the ability to translate complex information into clear, concise documentation. Key Responsibilities Develop, write, and edit technical documents, including user manuals, standard operating procedures, installation guides, and training materials, with a primary focus on technical reports and proposals. Collaborate with subject matter experts (SMEs), engineers, and project teams to gather and verify technical information. Create and maintain document templates and style guides to ensure consistency and compliance with industry standards and customer requirements. Research and understand technical concepts, systems, and products to effectively communicate their functionality and operation. Manage documentation lifecycle, including version control, updates, and archiving. Ensure all documentation complies with relevant regulations, standards, and contract requirements (e.g., ITAR, DFARS, MIL-STD). Incorporate feedback from cross-functional teams and stakeholders to refine and improve documentation. Utilize tools such as Adobe Acrobat, Microsoft Office, and specialized software (e.g., Visio, XML editors) to produce high-quality deliverables. Qualifications Education and Experience: Bachelor's degree in Technical Writing, English, Communications, Engineering, or a related field. Equivalent work experience may be considered. Minimum of 3-5 years of experience in technical writing, with a preference for experience in defense contracting, aerospace, or related industries. Familiarity with military standards (e.g., MIL-STD-38784) and defense-related documentation processes is strongly preferred. Technical Skills: Proficiency in tools such as Microsoft Office Suite, Adobe Creative Suite, and technical writing platforms like RoboHelp or MadCap Flare. Basic understanding of engineering and manufacturing concepts, with the ability to read and interpret technical drawings and specifications. Experience working with configuration management systems and version control software. Core Competencies: Exceptional written and verbal communication skills, with the ability to tailor content to diverse audiences. Strong organizational skills and the ability to manage multiple projects and deadlines. Detail-oriented with excellent analytical and problem-solving abilities. Ability to work both independently and collaboratively in a fast-paced environment. Preferred Qualifications Experience in proposal writing and documentation for government contracts. Working knowledge of regulatory compliance standards such as ITAR and EAR. Certification in technical writing or related fields is a plus. Work Environment Primarily office-based with occasional visits to manufacturing or testing facilities. May require occasional travel to meet with clients or project teams. This role offers the opportunity to contribute to cutting-edge projects within a dynamic and collaborative team. Why Join MSC? At MSC, we pride ourselves on pushing the boundaries of innovation and excellence in engineering. If you are passionate about technical communication and thrive in a challenging technical environment, we encourage you to apply. Application Process: Interested candidates are encouraged to submit their resume and cover letter detailing their relevant experience and accomplishments. MSC is an Equal Opportunity Employer.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description The position focuses on identifying how to set up computer systems, how to troubleshoot and writing the script and steps on how to complete. This is an on-site role, 5 days/week. The Spring House site is not connected with a public transportation line (such as a bus route), reliable transportation needed to get to and from site. We are seeking a meticulous and analytical User Acceptance Testing (UAT) Specialist / Technical Writer to join our team, focusing on lab-based testing software solutions. This dual-role position will ensure that our software applications meet the specific needs of laboratory environments while also producing clear and comprehensive documentation (SOPs, User Guides, Process Flows, Execution Resources). The UAT Specialist / Technical Writer will collaborate with laboratory personnel and IT to develop test plans, both write and execute test cases, and create user manuals and other technical documents to ensure high-quality deliverables. Test Planning, design and drafting Collaborate with IT and laboratory scientists, project managers, and stakeholders to understand requirements and define acceptance criteria specific to lab workflows Develop comprehensive UAT test plans and necessary test cases based on laboratory processes, regulatory requirements, and user stories Write specific test scripts that evidence the successful performance of the acceptance criteria Communicating all found bugs and defects in a timely fashion during this initial “smoke testing” process Test Execution Execute UAT test cases documenting results and identifying defects or issues related to software functionality. Defects and issues should be at a minimum with adequate hands on drafting time Self Execute test scripts or Facilitate UAT sessions with lab personnel (as needed) to gather feedback and validate software performance in real-world scenarios Defect Management Log and track defects using a defect management tool, ensuring timely resolution and effective communication with development teams Work closely with software developers to communicate issues and verify fixes, ensuring compliance with laboratory standards. Incorporate fixes into test scripts as needed Documentation and Reporting Prepare UAT reports summarizing test results, defect status and metrics surrounding the testing process Maintain clear and organized documentation of test cases, test results, and user feedback, ensuring traceability to laboratory requirements Technical Writing Documentation Development Create and maintain SOPs, user manuals, technical specifications, and other documentation to support software applications used in laboratory settings Collaborate with subject matter experts to gather information and ensure accuracy in technical documentation Content Review and Editing Review and edit documentation for clarity, consistency, and adherence to company standards Ensure that all documentation is user-friendly and accessible to laboratory personnel with varying levels of technical expertise Training Materials & Training Be capable of training users on new system functionality and providing demonstrations to senior management as needed Develop training materials and guides to assist laboratory staff in using new systems and features effectively Conduct training sessions as needed to ensure users understand the software and its functionalities Qualifications Minimum Qualifications Completed Bachelors degree in a scientific concentration Authorization to work in the United States indefinitely without restrictions or sponsorship Experience 2+ years of experience in scientific or related field software testing, with a strong focus on user acceptance testing Experience in technical writing, particularly in creating user manuals and technical documentation for software applications. Technical Skills Familiarity with software development life cycle (SDLC) and testing methodologies, especially in lab-based applications. Strong written and verbal communication skills Proficiency in using testing tools (e.g., Xray, JIRA, ALM (HP)) and an understanding of laboratory information management systems (LIMS). Experience with documentation software and Microsoft application tools is a plus. Soft Skills Strong analytical and problem-solving skills, with attention to detail. Excellent communication and interpersonal skills, particularly in an IT and lab environment. Ability to work independently and collaboratively within a team Preferred Qualifications Experience in Agile/Scrum methodologies. Exposure to regulatory standards relevant to laboratory software. Certification in software testing (e.g., ISTQB) and/or technical writing is an advantage. Work Environment This position may require occasional overtime and flexibility to meet project deadlines. The role may involve working in a laboratory setting, with adherence to safety protocols. Additional Information Position is full-time, Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of Spring House, PA are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Take the next step in your career path and join a team that facilitates the efficient operation of our Group Underwriting organization. As the Group Underwriting Senior Technical Writer in Group Benefits Underwriting, you will collaborate with colleagues in Underwriting, Underwriting Operations, and other functional areas to ensure that our colleagues have all the information needed to perform. This requires being systematic in analyzing, developing, validating, and publishing information about processes, policies, and our systems. This role also requires an ongoing evaluation of the information management and communication approach and continuous improvement of our processes, based on input from our colleagues and industry best practices. **You are:** + A team member who can manage multiple priorities, and who is passionate about logically organized and comprehensive information for our Group Underwriting colleagues. + Work together with teammates, content contributors, SMEs, leaders, and other interested parties on projects and to consistently improve our information management approach. + Skilled in documentation tools like Microsoft Word, SharePoint, and other web based knowledge management or online help systems; familiarity with policy administration systems is a plus. + Ability to interpret and document sophisticated underwriting processes, risk assessment criteria, and decision-making frameworks. + Comfortable working with underwriting teams, product managers, legal, and IT to gather source material and validate content. + Familiarity with regulatory standards and documentation practices in insurance. **You have:** + Proficiency in writing and editing technical content related to complex business processes, preferably in regulated industries such as insurance or healthcare. + A 4-year college degree in English, Communications, Technical Writing, or a related field, or equivalent work experience. + Knowledge of Group insurance products and services (a plus). + Project management experience (a plus). + Familiarity with process improvement and process design (Lean Six Sigma). + Experience completing tasks in a disciplined manner and meeting deadlines. + Optional: Ability to develop training materials using instructional design principles. **You will:** + Independently lead the development of reference information for complex projects to support the effectiveness and efficiency of our Group Underwriting organization. This information is commonly related to new products, policies, systems, tools, and processes. + Create Underwriting-specific content for our Information Management System (IMS). + Occasionally lead the weekly publication of the newsletter for all of Group Underwriting. + Lead the review process of existing Group Underwriting policies with team members. + Collaborate with the Information Management and Learning team to coordinate and work together on projects, and at times manage communications. + Collaborate with various areas including compliance, legal, and IT. **Location:** + Preferred location is Guardian's Office in Bethlehem, PA. 3 days onsite Hybrid **Salary Range:** $67,450.00 - $110,815.00 The salary range reflected above is a good faith estimate of base pay for the primary location of the position. The salary for this position ultimately will be determined based on the education, experience, knowledge, and abilities of the successful candidate. In addition to salary, this role may also be eligible for annual, sales, or other incentive compensation. **Our Promise** At Guardian, you'll have the support and flexibility to achieve your professional and personal goals. Through skill-building, leadership development and philanthropic opportunities, we provide opportunities to build communities and grow your career, surrounded by diverse colleagues with high ethical standards. **Inspire Well-Being** As part of Guardian's Purpose - to inspire well-being - we are committed to offering contemporary, supportive, flexible, and inclusive benefits and resources to our colleagues. Explore our company benefits at *********************************************** . _Benefits apply to full-time eligible employees. Interns are not eligible for most Company benefits._ **Equal Employment Opportunity** Guardian is an equal opportunity employer. All qualified applicants will be considered for employment without regard to age, race, color, creed, religion, sex, affectional or sexual orientation, national origin, ancestry, marital status, disability, military or veteran status, or any other classification protected by applicable law. **Accommodations** Guardian is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. Guardian also provides reasonable accommodations to qualified job applicants (and employees) to accommodate the individual's known limitations related to pregnancy, childbirth, or related medical conditions, unless doing so would create an undue hardship. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact applicant_accommodation@glic.com . **Current Guardian Colleagues: Please apply through the internal Jobs Hub in Workday.** Every day, Guardian helps our 29 million customers realize their dreams through a range of insurance and financial products and services. Our Purpose, to inspire well-being, guides our dedication to the colleagues, consumers, and communities we serve. We know that people count, and we go above and beyond to prepare them for the life they want to live, focusing on their overall well-being - mind, body, and wallet. As one of the largest mutual insurance companies, we put our customers first. Behind every bright future is a GuardianTM. Learn more about Guardian at guardianlife.com . Visa Sponsorship: Guardian Life is not currently or in the foreseeable future sponsoring employment visas. In order to be a successful applicant, you must be legally authorized to work in the United States, without the need for employer sponsorship.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description The position focuses on identifying how to set up computer systems, how to troubleshoot and writing the script and steps on how to complete. This is an on-site role, 5 days/week. The Spring House site is not connected with a public transportation line (such as a bus route), reliable transportation needed to get to and from site. We are seeking a meticulous and analytical User Acceptance Testing (UAT) Specialist / Technical Writer to join our team, focusing on lab-based testing software solutions. This dual-role position will ensure that our software applications meet the specific needs of laboratory environments while also producing clear and comprehensive documentation (SOPs, User Guides, Process Flows, Execution Resources). The UAT Specialist / Technical Writer will collaborate with laboratory personnel and IT to develop test plans, both write and execute test cases, and create user manuals and other technical documents to ensure high-quality deliverables. * Test Planning, design and drafting * Collaborate with IT and laboratory scientists, project managers, and stakeholders to understand requirements and define acceptance criteria specific to lab workflows * Develop comprehensive UAT test plans and necessary test cases based on laboratory processes, regulatory requirements, and user stories * Write specific test scripts that evidence the successful performance of the acceptance criteria * Communicating all found bugs and defects in a timely fashion during this initial "smoke testing" process * Test Execution * Execute UAT test cases documenting results and identifying defects or issues related to software functionality. Defects and issues should be at a minimum with adequate hands on drafting time * Self Execute test scripts or Facilitate UAT sessions with lab personnel (as needed) to gather feedback and validate software performance in real-world scenarios * Defect Management * Log and track defects using a defect management tool, ensuring timely resolution and effective communication with development teams * Work closely with software developers to communicate issues and verify fixes, ensuring compliance with laboratory standards. * Incorporate fixes into test scripts as needed * Documentation and Reporting * Prepare UAT reports summarizing test results, defect status and metrics surrounding the testing process * Maintain clear and organized documentation of test cases, test results, and user feedback, ensuring traceability to laboratory requirements Technical Writing * Documentation Development * Create and maintain SOPs, user manuals, technical specifications, and other documentation to support software applications used in laboratory settings * Collaborate with subject matter experts to gather information and ensure accuracy in technical documentation * Content Review and Editing * Review and edit documentation for clarity, consistency, and adherence to company standards * Ensure that all documentation is user-friendly and accessible to laboratory personnel with varying levels of technical expertise * Training Materials & Training * Be capable of training users on new system functionality and providing demonstrations to senior management as needed * Develop training materials and guides to assist laboratory staff in using new systems and features effectively * Conduct training sessions as needed to ensure users understand the software and its functionalities Qualifications Minimum Qualifications * Completed Bachelors degree in a scientific concentration * Authorization to work in the United States indefinitely without restrictions or sponsorship * Experience * 2+ years of experience in scientific or related field software testing, with a strong focus on user acceptance testing * Experience in technical writing, particularly in creating user manuals and technical documentation for software applications. * Technical Skills * Familiarity with software development life cycle (SDLC) and testing methodologies, especially in lab-based applications. * Strong written and verbal communication skills * Proficiency in using testing tools (e.g., Xray, JIRA, ALM (HP)) and an understanding of laboratory information management systems (LIMS). * Experience with documentation software and Microsoft application tools is a plus. * Soft Skills * Strong analytical and problem-solving skills, with attention to detail. * Excellent communication and interpersonal skills, particularly in an IT and lab environment. * Ability to work independently and collaboratively within a team Preferred Qualifications * Experience in Agile/Scrum methodologies. * Exposure to regulatory standards relevant to laboratory software. * Certification in software testing (e.g., ISTQB) and/or technical writing is an advantage. Work Environment * This position may require occasional overtime and flexibility to meet project deadlines. * The role may involve working in a laboratory setting, with adherence to safety protocols. Additional Information Position is full-time, Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of Spring House, PA are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

JOIN OUR COMMUNITY ACTION TEAM: Planner/Grant Writer Are you passionate about creating meaningful change in your community? At Community Action Lehigh Valley, we're looking for a strategic thinker and strong writer to join our team as a Planner/Grant Writer. This role is ideal for experienced nonprofit professionals who are eager to advance social change through planning, advocacy, and resource development. You'll play a key role in shaping innovative programs and securing critical funding that directly impacts individuals and families across the Lehigh Valley. YOUR IMPACT AS: Planner/Grant Writer for Community Action Lehigh Valley As our Planner/Grant Writer, you'll work alongside agency leadership and program directors to support the development, funding, and evaluation of life-changing programs. From writing grants that fuel our work, to building partnerships that strengthen our impact, your contributions will support our mission to empower low-income communities and advocate for equitable policies. You'll also take the lead in researching community needs, crafting strategic plans, and engaging with coalitions driving long-term change. Your problem-solving skills and commitment to equity will help turn ideas into actionable, sustainable solutions. WHAT YOU NEED TO BE SUCCESSFUL: To thrive in this role, you'll bring a mix of creativity, strategic thinking, and a deep commitment to community-driven change. We're looking for someone who loves writing, excels at problem-solving, and knows how to turn big ideas into actionable plans. A bachelor's degree in a writing-intensive or social sciences program is required, and while a master's degree in areas like public policy, social work, or housing and food policy is preferred, we also welcome candidates with equivalent experience and a strong track record in the nonprofit space. Ideally, you'll have 2-3 years of experience in program development and fund development-especially grant writing. If you enjoy working with data, building community coalitions, and advocating for social change, you'll fit right in. Strong communication skills, attention to detail, and the ability to work both independently and collaboratively will set you up for success in this meaningful role. READY TO MAKE A DIFFERECNE? If you're ready to make a real difference and have the fundraising skills and experience to drive impactful change, we encourage you to apply. * NOTE: COVER LETTER REQURIED FOR CONSIDERATION Enter your cover letter as a formal correspondence that includes a salutation and signature. The most successful applications address one specific position. Please: (a) be position-centric in describing how you meet the for the Planner / Grant Writer posting; (b) provide a motivational statement to show why you find the position compelling; (c) note whether you also have desired qualifications; (d) limit comments about experience, knowledge and skills that are extraneous to the position to one or two sentences at the end (maximum 4000 character limit, including spaces and punctuation). We look forward to your submissions! WHY JOIN US: WE OFFER COMPREHENSIVE BENEFITS Comprehensive Medical, Dental, Vision, And Prescription Plans! Free Telemedicine Access to Board-Certified Doctors, Mental Health Professionals And MORE! No Cost Concierge Services to Support You in Navigating the Healthcare System Agency Paid Life Insurance and Long-Term Disability Insurance Voluntary Life Insurance and Short-Term Disability Insurance options 401 (K) Retirement Plan with Matching Annual Agency Contribution of up to 7% We Offer Generous Paid Leave Time: Vacation - 15 Days: Earn More Time After 2- And 5-Year Anniversaries 2 Personal Days Annually to Use at Your Leisure Sick - 9 Days Annually 10 Observed Holidays - Including a floating cultural holiday of your choice! JOIN OUR TEAM TODAY! See below for the full job description. If you are excited about using your skills to make a positive impact on our community, we look forward to meeting YOU! Completion of a background investigation including; PA State Police criminal record check, Child Abuse History Clearance, and FBI Criminal History background check will be required for this position. The information we collect helps Community Action Lehigh Valley promote a safe and secure environment for our current and future employees, and the clients and communities we serve. Background information will only be used as part of the employment process and is kept strictly confidential. Completion of a background investigation including; PA State Police criminal record check, Child Abuse History Clearance, and FBI Criminal History background check will be required for this position. The information we collect helps Community Action Lehigh Valley promote a safe and secure environment for our current and future employees, and the clients and communities we serve. Background information will only be used as part of the employment process and is kept strictly confidential.

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Technical Business Analyst to join our team in King of Prussia, Pennsylvania (US-PA), United States (US). Job Description: We are seeking a detail-oriented and proactive Business Analyst to support a high-impact Reporting Project. The successful candidate will act as a liaison between finance stakeholders and technical teams, gathering and analyzing business requirements, optimizing reporting processes, and ensuring the timely and accurate delivery of financial reports. This role requires a solid understanding of finance concepts, reporting standards, and business intelligence tools, along with strong communication and analytical skills. Required Qualifications: + Bachelor's (or above) degree in Finance, Accounting, Business Administration, or related field. + 5-7 years of experience as a Business Analyst in the Finance domain. + Excellent communication and collaboration skills. Required Skills: + Strong understanding of financial reporting and accounting principles. + Hands-on experience with BI/reporting tools like Power BI. + Proficient in SQL and data analysis techniques. + Strong analytical mindset and attention to detail. + Familiarity with Snowflake. Responsibilities: + Collaborate with Finance, Accounting, and IT stakeholders to gather, document, and validate reporting requirements. + Analyze current reporting structures and identify areas for improvement, automation, and standardization. + Define business requirements, use cases, and data mapping for new or enhanced financial reports and dashboards. + Translate business needs into functional specifications for data engineers, report developers, or BI teams. + Work closely with technical teams during design, development, testing, and deployment phases. + Conduct UAT (User Acceptance Testing), ensuring reports meet business expectations and compliance standards. + Support change management and end-user training initiatives for report rollout. + Monitor reporting performance post-deployment and coordinate enhancements or issue resolutions. + Maintain documentation including requirements traceability, data definitions, and report logic. About NTT DATA: NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at us.nttdata.com NTT DATA endeavors to make ********************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at **********************/en/contact-us. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.

The Grant Specialist will serve as the College of Arts & Sciences' primary resource for pre-award contract and grant management, while also developing post-award expertise to support and guide department-level business managers in research-related financial administration. This role, reporting to the Associate Director of Finance & Budget, is key to enhancing the college's research infrastructure and ensuring compliance, efficiency, and high-quality service across all stages of the grant lifecycle. Position Number: S97350 This position is a Grade: 8 - 40 with an approximate salary range of $46,870-$56,250 and is subject to change based on experience, skills and qualifications. Key Responsibilities: * Manage proposal submissions for Principal Investigators (PIs) from from identification to submission * Serve as the first point of contact for faculty and staff engaging with the CAS Research Office, acting as resource for proposal development * Identify funding opportunities for faculty and students while familiarizing them with available tools, resources and databases * Guide faculty in budget preparation, document collection, and subsequent revisions based on awarded amounts (if varies from proposed budget) * Interpret sponsor guidelines, confirm PI and institutional eligibility, and ensure adherence to regulations and deadlines * Initiate records and assist investigators in utilizing the Lehigh Integrated Research Administration (LIRA) system * Collaborate closely with Contract and Grant Specialists within the Office of Research and Sponsored Programs (ORSP) to facilitate timely and compliant submission of proposals * Prepare administrative components of pre-award requests from sponsors * Keep abreast of sponsor updates, university policies and changes in research administration, including any upcoming changes to the LIRA system * Maintain up-to-date knowledge of Uniform Guidance, university policies and procedures, and sponsor-specific updates * Provide early-stage post-award guidance to ensure expenditures align with proposed budgets * Participate in research community training and coordinate with ORSP on research "hot topics" in research administration * Collaborate with university systems and LTS to streamline CAS-specific workflows (e.g., grant applications, EPAF/payroll processes). * Gain and maintain expertise in key university platforms, including Banner, LIRA, and Argos. * Develop and maintain training resources and user guides for common research administration tasks. * Oversee content management for the CAS Research website to ensure timely and accurate information is available to faculty and staff. * Recommend and help implement process improvements to enhance efficiency, compliance, and service delivery. * Plan and facilitate college-wide workshops (e.g., LIRA and Argos training) to build research administration capacity across departments. * Support supervisor on ad hoc research-related projects and initiatives. * Act as a resident consultant for CAS business managers with questions related to research budgets, research payroll allocations, and related administrative processes. * Provide guidance and collaborate on post-award activities, including budget monitoring, expense/payroll reallocations, effort reporting, and compliance with award terms and university policies. * Assist CAS Financial team, sometimes including faculty, with grant financial forecasting based on existing budget, renewals and expected future liabilities. * Collaborate with CAS Financial team to maintain a database of research summer salary obligations and academic year course releases. * Manage compliance with University policy on overload pay and process associated payroll documents as needed. * Serve as a subject matter resource to department-level business managers, helping them navigate research-related financial tasks and ensuring consistency with best practices and compliance. * Collaborate with the CAS Financial Team to foster an integrated, full-cycle approach and understanding to grant management. * Review graduate student research appointments and tuition submissions to ensure accuracy against budgets. * Identify opportunities to improve pre- and post-award processes and tools that support transparency, accountability, and efficiency. * Supports development of policies, procedures, tools, and communications for grants administration and trains staff as needed. * Provide support for college-level events, presentations, and special projects as needed. * Assist the Dean's Office and financial team during peak workload periods or staff absences, contributing to a collaborative and responsive office environment. Qualifications: * Bachelor's Degree in Grant Administration, Business, Management, Analysis, Financial, Communications, or other related field * One to three years of related work experience * Excellent computer skills with experience an comfort using Microsoft Office and Adobe Acrobat * Comfortable learning new, complex software systems Lehigh University is an equal opportunity employer and does not discriminate. We are committed to a culturally and intellectually diverse community and we seek qualified candidates to contribute to the university's mission. Lehigh University offers a comprehensive and family friendly benefits package which includes but is not limited to Health Care, Retirement and Educational benefits. Information can be found on our website. Persons with disabilities who anticipate needing an accommodation for any part of the interview or hiring process may contact Lehigh's Accommodations Specialist. Successful completion of standard background checks including but not limited to: social security verification, education verification, national criminal background checks, motor vehicle checks, PATCH, FBI fingerprinting, Child Abuse Clearance and credit history based upon the requirements of the position. Only complete applications will be considered therefore please complete the application in its entirety. Once the posting is removed from the website applications may no longer be allowed to be completed.

The applicant will write Product Risk Assessment documents for Pharmaceutical Products and require specific experience in Risk assessments of combination products and/or medical devices. The applicant should have experience using risk management methodologies, tools, incorporate appropriate data and information, and conduct risk calculations. The applicant must understand pharmaceutical and/or device manufacturing processes, design controls, and be able to lead and conduct FMEAs. Specific experience with user/design/process FMEAs for medical devices is desirable. A minimum of Five (5) years experience is required. The applicant should be proficient in Microsoft Word, Excel, Visio, Microsoft Project and have experience with documentation systems. The applicant must have experience in leading and facilitating teams to finalize reports with approvals per standard operating procedures. The incumbent will work with medical, technical, manufacturing, and quality groups to develop Product Risk Assessments by conducting risk analysis for pharmaceutical products. Job Responsibilities include: • Collate appropriate and pre-populating the document based on product information, patient/user information, and other supporting documents. (the incumbent should have the ability to search these documents, understand the process and extract required information) • Ensure proper formatting, proof read, and route for approval in documentation system. • Maintain and update project status in Microsoft Project, excel. Key Decisions: • Participates in decisions and provides input and prepares product risk management reports regarding the adequacy, accuracy, interpretation, and clarity, and final decisions made by the project team. • Consults with appropriate groups (as required) regarding the acceptability of documentation Key Competencies: Project Management Organization and Time Management Communication (Verbal, Written, and Interpersonal) Qualifications Education/Experience Requirements: • Bachelor's degree in Chemistry, Pharmacy or a related science field plus 4-6 years of relevant experience industrial experience in the healthcare industry • OR MS/PhD/Pharm.D. plus 3-4 years of pharmaceutical industrial experience • Minimum of 1-2 years of technical writing experience for manufacturing related activities is mandatory • Experience working in the Pharmaceutical manufacturing industry (preferably in Technical Services, Operations, manufacturing plant or Research & Development or QA, knowledge of pharmaceutical development processes, cGMPs and regulatory requirements are required. • Excellent English, writing and oral presentation skills is mandatory • Prior experience with Pharmaceutical Industry is mandatory • Prior experience managing projects is preferred Additional Information Job Description: Write technical materials, such as SOP's, appendices Duties and Responsibilities: • Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology. • Maintain records and files of work and revisions • Edit, standardize, or make changes to material prepared by other writers or establishment personnel • 2+ years experience as a Technical Writer • 2+ years primary role writing user documentation for a variety of products, prepared as part of an integrated team • Proofing/preparation of documentation

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Qualifications: Background: • BS or MS degree in arts or sciences • 4+ years of technical writing experience • Experience in change management • Experience in medical, pharmaceutical, or other FDA regulated environment • Understanding of CAPA and Quality process • Strong knowledge of the English Language -- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. • Knowledge of computer hardware and software, including Microsoft Office, Visio, Adobe Acrobat applications. • Communicating effectively in writing as appropriate to the audience. • Strong prioritization and multitasking skills. Managing one's own time and the time of others. Responsibilities: • Manage the documentation, change order, and change control processes • Experience with computer based change management software. Write change plans, document change orders • Maintain records and files of work and revisions • Develop SOPs and associated technical documentation as required • Interview and build relationships with SMEs in cross functional groups, including walking down a process to insure completeness and verify correctness • Edit, standardize, or make changes to material prepared by SMEs or other Company personnel • Manage new documentation and revised documentation through lifecycle and document management system • Help with investigations, non-conformances and CAPA process • Confer with customer representatives, vendors, regulatory personnel, or others to establish technical specifications • Review established documentation and recommend revisions or changes in scope, format, and content • Spend time with SMEs observing production, developmental, and experimental activities to determine operating procedure and detail. • Develop specific goals and plans to prioritize, organize, and accomplish your work. Additional Information Regards, Sweta Verma IT Recruiter Integrated Resources, Inc. Inc. 5000 - 2007-2014 (8th Year) Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70 (Direct) 732 549 5907 | (W) 732 -549 - 2030 x 210| (F) (732) 549 5549

Insight Global is looking for a bilingual (English and Spanish) technical writer for one of our biotech and pharma clients to sit in Raritan, NJ. This individual will directly translate records, log books, SOPs and other technical documentation related to our client's CART Training curriculum. Responsiblities include: Performing direct, clear translations that maintain the intent, tone, and technical meaning of the original documents. Uploading, organizing, and maintaining translated documents within internal systems and databases. Ensure consistency in terminology and formatting across all translated materials. Collaborate with team members to clarify document context and ensure translations meet operational needs. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements Pharmaceutical and biotech experience - GMP knowledge Fluency in English and Spanish (written and verbal) Experience translating technical and operational documents

Job Description We are seeking an experienced Technical Writer with a strong background in defense contracting, aerospace, or other related technical fields. The ideal candidate will be responsible for creating, editing, and maintaining technical documentation that meets industry standards and supports the needs of both internal and external stakeholders. This role requires exceptional attention to detail, technical acumen, and the ability to translate complex information into clear, concise documentation. Key Responsibilities Develop, write, and edit technical documents, including user manuals, standard operating procedures, installation guides, and training materials, with a primary focus on technical reports and proposals. Collaborate with subject matter experts (SMEs), engineers, and project teams to gather and verify technical information. Create and maintain document templates and style guides to ensure consistency and compliance with industry standards and customer requirements. Research and understand technical concepts, systems, and products to effectively communicate their functionality and operation. Manage documentation lifecycle, including version control, updates, and archiving. Ensure all documentation complies with relevant regulations, standards, and contract requirements (e.g., ITAR, DFARS, MIL-STD). Incorporate feedback from cross-functional teams and stakeholders to refine and improve documentation. Utilize tools such as Adobe Acrobat, Microsoft Office, and specialized software (e.g., Visio, XML editors) to produce high-quality deliverables. Qualifications Education and Experience: Bachelor's degree in Technical Writing, English, Communications, Engineering, or a related field. Equivalent work experience may be considered. Minimum of 3-5 years of experience in technical writing, with a preference for experience in defense contracting, aerospace, or related industries. Familiarity with military standards (e.g., MIL-STD-38784) and defense-related documentation processes is strongly preferred. Technical Skills: Proficiency in tools such as Microsoft Office Suite, Adobe Creative Suite, and technical writing platforms like RoboHelp or MadCap Flare. Basic understanding of engineering and manufacturing concepts, with the ability to read and interpret technical drawings and specifications. Experience working with configuration management systems and version control software. Core Competencies: Exceptional written and verbal communication skills, with the ability to tailor content to diverse audiences. Strong organizational skills and the ability to manage multiple projects and deadlines. Detail-oriented with excellent analytical and problem-solving abilities. Ability to work both independently and collaboratively in a fast-paced environment. Preferred Qualifications Experience in proposal writing and documentation for government contracts. Working knowledge of regulatory compliance standards such as ITAR and EAR. Certification in technical writing or related fields is a plus. Work Environment Primarily office-based with occasional visits to manufacturing or testing facilities. May require occasional travel to meet with clients or project teams. This role offers the opportunity to contribute to cutting-edge projects within a dynamic and collaborative team. Why Join MSC? At MSC, we pride ourselves on pushing the boundaries of innovation and excellence in engineering. If you are passionate about technical communication and thrive in a challenging technical environment, we encourage you to apply. Application Process: Interested candidates are encouraged to submit their resume and cover letter detailing their relevant experience and accomplishments. MSC is an Equal Opportunity Employer.

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Technical Writers is the frequent open position in Johnson & Johnson. Please share below the details and your updated resume with us so that I would be able to submit you first compare to other candidates in order to get the in -personal interview request from the company. I would like to mention that Johnson & Johnson has fastest interview process, as per our multiple year of experience, they moves very fast with the in - personal and offer. We have placed so many candidates, those we have submitted in an hours when the position comes in. Take some smart step and get the job in one of the leading healthcare company - Johnson & Johnson. Please provide the below details Total Experience - Expected Rate - Current Rate - Visa Status - DOB( Just Date and month is require for submission purpose ) - Available for in person - Available to Join - Location - Work Status - Qualification- In considering candidates, time is of essence so please respond ASAP. Additional Information Contact- Tel: (732) 549 2030 x 210 Sweta Verma

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description RESPONSIBILITIES: • Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products. • High quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. • Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management. • Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical, and other key stakeholders. • Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents. • Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents. • Manage contract writers, as well as internal writers. • Highly organized, ability to prepare technical reports, summaries, protocols, and quantitative analyses TECHNICAL KNOWLEDGE: • Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy. • Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents. • Able to complete and turn around high quality outputs with only minimal guidance from management. Qualifications QUALIFICATIONS AND SKILLS NEEDED: • Scientific/medical academic background (e.g., MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field), or equivalent. • Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance. • Experience with oncology and eCTD filing preferred. Additional Information Tel: 732-429-1921 http://www.irionline.com

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description The Medical Writer is responsible for medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products. This will be achieved by applying analytical skills, functional literacy and expertise in document preparation. RESPONSIBILITIES: • Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products. • High quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. • Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management. • Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical, and other key stakeholders. • Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents. • Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents. • Manage contract writers, as well as internal writers. • Highly organized, ability to prepare technical reports, summaries, protocols, and quantitative analyses. Qualifications • Scientific/medical academic background (e.g., MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field), or equivalent. • Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance. Additional Information TECHNICAL KNOWLEDGE: • Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy. • Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents. • Able to complete and turn around high quality outputs with only minimal guidance from management.

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description RESPONSIBILITIES: • Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products. • High quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. • Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management. • Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical, and other key stakeholders. • Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents. • Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents. • Manage contract writers, as well as internal writers. • Highly organized, ability to prepare technical reports, summaries, protocols, and quantitative analyses TECHNICAL KNOWLEDGE: • Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy. • Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents. • Able to complete and turn around high quality outputs with only minimal guidance from management. Qualifications QUALIFICATIONS AND SKILLS NEEDED: • Scientific/medical academic background (e.g., MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field), or equivalent. • Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance. • Experience with oncology and eCTD filing preferred. Additional Information Tel: 732-429-1921 http://www.irionline.com

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Looking for Medical Writers in Springhouse, PA Client -Johnson and Johnson Please share the updated resume at sweta(at)irionline.com Additional Information