Medical writer jobs in Raleigh, NC

Principal Medical Writer At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Our Medical Writing team is growing, and we are looking for a Principal Medical Writer. This role is based in the United States. Discover Impactful Work: Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Regulatory Medical Writing documents, such as protocols, CSR, Investigator Brochures, and Marketing Applications, ensuring outstanding quality and compliance. A Day in the Life: Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. As an essential advisory member of the writing team, may provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry best practices. May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. Keys to Success: Acts with intensity Strong project management skills Excellent interpersonal skills including problem solving and negotiation Able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Education Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Experience in managing and directing complex Regulatory medical writing projects required Experience working in the pharmaceutical/CRO industry preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous. Knowledge, Skills, Abilities Significant knowledge of global, regional, national and other document development guidelines Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, marketing application submissions, communications, etc Strong project management skills Excellent interpersonal skills including problem solving and decision-making Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook); willingness to utilize technology to support authoring efficiency Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! What We Offer: As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities * Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately * Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision * Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings * Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides * Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately * Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format * Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs * Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables * Perform online clinical literature searches and comply with copyright requirements * Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff * Mentor and lead less experienced medical writers on complex projects * Develop deep expertise on key topics in the industry and regulatory requirements * Work within budget specifications for assigned projects Qualifications: * Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred * 3-5 years of relevant experience in science, technical, or medical writing * Experience working in the biopharmaceutical, device, or contract research organization industry required * Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required * Experience writing relevant document types required * Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills: * Strong presentation, proofreading, collaborative, and interpersonal skills * Strong project and time management skills * Strong proficiency in MS Office * Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $80,600.00 - $145,000.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus • Leading the clear and accurate completion of medical writing deliverables • Managing medical writing activities associated with individual studies • Coordinating these activities within and across departments • Completing a variety of documents, adhering to established regulatory standards • Coordinating quality and editorial reviews • Acting as peer reviewers for the internal team • Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency • Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs • Performing online clinical literature searches and complying with copyright requirements • Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff • Mentoring and leading less experienced medical writers on complex projects • Developing deep expertise on key topics in the industry and regulatory requirements • Working within budget specifications for assigned projects

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. The Principal Medical Writer position is responsible for authoring medical writing deliverables with a focus on quality, accuracy, and efficiency, and provides medical writing support to ProPharma clients. Essential Functions: Ensures appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants as applicable. Manages clinical program documents for assigned clients, such as protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, as well as more complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submissionlevel documents) as assigned. Leads cross-functional coordination of resources (e.g., internal resources/consultants) to manage medical writing and QC deliverables as assigned. Independently authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents). Supervises, trains, and mentors less experienced medical writers, as necessary. Adheres to established regulatory standards/guidelines including but not limited to: ICH E3 or E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates. Strives to complete medical writing deliverables on time and within budget. Independently manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines. Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce medical writing deliverables. Coordinates QC reviews of documents and maintains audit trails of changes as applicable. Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency. If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output). Performs peer review of documents written by other medical writers, as . Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings). Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing. Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership. Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team. Brings issues and potential concerns to line manager/client oversight manager's attention and proposes possible solutions for consideration by management team. Participates in and leads departmental initiatives (e.g., process improvement, lunch and learns, etc.). Other duties as assigned. Necessary Skills and Abilities: Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information. Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines. Advanced understanding of regulatory submission requirements and processes. Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures. Exceptional project management skills and strong communication skills with a high attention to detail and quality. English language proficiency and familiarity with American Medical Association (AMA) style. Strong experience in relationship building and strategic collaboration on key business accounts. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables. Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Educational Requirements: Bachelor's degree or higher, preferably in medical or scientific discipline. Experience Requirements: Minimum of 7 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a casebycase basis. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Trilogy Writing & Consulting, an Indegene Company, is hiring Senior/Principal Medical Writers (USA) to support our growing company in producing regulatory documentation for the international pharmaceutical industry. At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing. Our writers are integral members of clinical development teams supporting the writing and coordination of successful documentation across a broad spectrum of therapeutic areas. As our company continues to expand, there is room to develop with us, and your ideas will form our future together. For further insight into who we are and what we do, please explore our website (************************ If this excites you, then apply below. Applicants must live in the USA and be authorized to work for any employer in the USA (we are unable to sponsor or take over sponsorship of an employment visa at this time); may work either fully remotely or a hybrid schedule (in office/remote) from our Durham, NC, USA office. You will be responsible for: Preparing a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate. Ensuring that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company's clients. Providing document-specific advice to clients. Overseeing and coordinating other writers and QC specialists assisting on documents under your responsibility. Project managing the timelines and review cycles of your documents. Working in the client's regulatory document management systems. Your impact: As a Senior/Principal Medical Writer, you will: Function as a lead writer to prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) in collaboration with members of client authoring teams and supported by other writers, as appropriate. Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company's clients. Be responsible for providing document-specific advice to clients. Oversee and coordinate other writers and QC specialists assisting with documents under your responsibility. Project manage the timelines and review cycles of your documents. Work in the client's regulatory document management systems. Qualified applicants must have: A minimum of a Bachelor's degree in science/pharmacy (Ph.D. not necessary). Fluent written and spoken English skills. A minimum of 3-5 years of experience of actively writing regulatory documents; experience as a lead writer on CTD documents is required for Principal Medical Writer. Must have worked as the lead writer on key regulatory document(s) such as: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications. For Principal Medical Writer, must have experience as the lead writer with multiple-document projects with global, multinational teams, including team management, project management, review management, and budget oversight. Must be able to manage multiple projects simultaneously. Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines. Must have in-depth working knowledge of the relevant regulatory guidance (e.g. ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance. For Principal Medical Writer, Experience in multiple therapeutic areas to have confidence to work in these areas without lead-in time. Competency in the use of document management systems and review tools. Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines. For the Principal Medical Writer level, ability and willingness to take on any project for which a Lead Writer is needed. Competency in the use of document management systems and review tools. An appreciation for a well-written document and an eye for details. Excellent, proven interpersonal skills, and enjoy proactively participating on a team with diverse personalities. Flexibility and the ability to stay focused under tight timelines. Perks: Competitive base salary (range: $120,000 to $159,000 USD; the salary range is an estimate and may vary based on experience level, region, and the Company's compensation practices) Annual bonus opportunity A generous allowance of paid time off (vacation, holiday, birthday, illness). Comprehensive benefit plans to include medical, dental, vision, disability, life insurance with AD&D. 401K retirement savings plan with company match Full AMWA membership and annual conference attendance paid for by Trilogy Continuous personal and professional development opportunities Free weekly yoga sessions Other fun and exciting events that encourage team bonding and development EQUAL OPPORTUNITY Trilogy Writing & Consulting, an Indegene Company, is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate's merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service. **How you'll make an impact:** + Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department + Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties + Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle + Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams + Review and interpret study data analyses + Contribute to the generation of product life cycle plans (e.g., post-market surveillance). **What you'll need (Required):** + Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria + Demonstrated track record in people management or equivalent work experience based on Edwards criteria **What else we look for (Preferred):** + Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria + Medical writing or regulatory certification or equivalent work experience based on Edwards criteria + Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria + Experience working in a regulated industry or equivalent work experience based on Edwards criteria + Certification in related fields + Strong leadership in project and team management, including coaching and performance oversight. + Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines. + Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations. + Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). + Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate. + Familiarity with coronary interventional and structural heart environments. + Proven ability to develop metrics demonstrating medical writing value to the business. + Ability to thrive in a fast-paced, dynamic environment with strict attention to detail. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life . Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities JOB SUMMARY Creates clear, concise, persuasive, strategic proposals based on input from business development (BD) and operational leadership for strategic partnership, must-win, and/or complex programmatic opportunities. Develops customized and targeted proposals, strategic partnership documents and prospective proposals across all therapeutic areas, functions and phases of clinical development. JOB RESPONSIBILITIES Leads strategy development conveyed in proposal documents, ensuring alignment with Syneos Health style, branding, messaging, and business objectives. Collaborates with internal stakeholders (e.g., BD, operational, medical, finance, and proposals) to develop concise, creative strategies that effectively articulate customer needs and win themes critical to generating new business awards. Creates high-quality, customized and compelling proposal documents focused on customer solutions that highlight company differentiation, innovation and operational strategy. Actively drives the proposal strategy from concept through final delivery. Actively engages in shaping study-specific strategy by making recommendations for cross-organizational services, tools, and technology that differentiate the organization from the competition. Challenges stakeholders to think creatively, proposing innovative solutions that align with customer and patient needs. Researches assigned project indication, applying learnings to inform discussions, as well as strategy and content development. Drives actions by clearly communicating project milestones and team member responsibilities, allowing flexibility to adapt as priorities shift while maintaining a balance between acquiring necessary input and customer deadlines. Builds strong relationships with stakeholders and decision makers to expedite problem solving and promote seamless collaboration. Approaches projects with enthusiasm, supporting ongoing engagement of team members. Identifies key content for archiving and proactively fills content gaps, developing new content that enhances Syneos Health competitive position. Develops deep knowledge of customers and/or function segmentation to align Syneos Health with customer objectives and needs. Serves as the document owner and writer for complex, high-profile RFPs, RFIs, and proactive outreach projects, synthesizing input from multiple contributors into cohesive, persuasive narratives. Takes an active role in resolving conflicts and removing barriers to maintain progress toward high-quality deliverables, independently or with support as needed. Coaches and mentors junior proposal writers to further develop their skills in writing concise, strategic content and effectively promoting consensus among team members with potentially disparate views. Shares best practices and strategic insights across the Strategic Writing and broader proposal development teams to ensure quality and consistent messaging. Performs other duties as assigned. QUALIFICATION REQUIREMENTS BA/BS in life sciences, marketing, communications, business administration, or a related discipline. 3-5 years of experience in the CRO, pharmaceutical, or biotechnology industry including technical writing, communications, or marketing experience. Proposal experience strongly preferred. Expert knowledge of the drug development process including functional operations and regulatory guidelines and directives. Demonstrated ability to evaluate scientific and business information (e.g., clinical trial protocols) and use conclusions to write persuasive and technical sales documents. Advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Experience with SharePoint and additional industry-related tools preferred (e.g., AI). Excellent oral and written communication skills; fluent in reading, writing, and speaking English. Strong interpersonal, organizational, analytical, presentation, and negotiation skills. Strong orientation toward customer service and high level of personal responsibility and quality. Strong project and process management skills with ability to lead and mentor others. Ability to lead large, complex, cross-functional teams to achieve objectives. Ability to work under pressure in a deadline-driven environment while maintaining accuracy, quality, and detail. Ability to comfortably engage with executive and senior management. Ability to be flexible, adapt to change, work independently, as well as work as part of a team in a matrix environment. Resourceful and proactive. Ability to multitask under tight deadlines on several projects with specific and unique requirements, while maintaining attention to detail and high-quality work. Keen observer, listener, and communicator with problem solving abilities. Strong orientation toward customer service and high level of personal responsibility and quality. Passion for turning complex ideas into compelling stories. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $79,800.00 - $139,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

vTech can help you avoid the daunting task of writing and posting job offers, shifting through resumes and laboring through the lengthy interview process. Our Staffing solutions will allow you to elude those tasks and place topnotch, high-caliber professionals in the position you need to fill. We use our expertise, knowledge, and global resources to deliver top-quality candidates and tailor our IT and Non-IT recruitment services to your needs. This allows us to deliver the required results in a timely manner that meets your schedule at a substantially reduced cost. We pride ourselves for having one of the fastest growth rate and also the lowest turnover rates in the industry just 2.5 percent annually. We focus on the training and retaining qualified professionals with high personal and work ethics. With the help of our extensive database of internal candidates and CATS applicants tracking system, we can provide quality resources within the limited time frame. We have also successfully placed hundreds of candidates in the areas related to Information Technology, Engineering, professional, Scientific & Clinical, etc. for both our commercial and government clients. Source: A recruiter sources candidates from various sources; the search starts from our proprietary database. Using advanced sourcing methods like social media, professional networking media, internal, and 3rd party job boards, we identify qualified candidates. Validate: A recruiter validates the candidates' experience and skill sets against our client's position. Initial Screening: Based on the position and the client's work culture, the recruiter uses initial screening questions to determine the most suitable candidates. Submit: the recruiter will submit to the technical team qualified candidates who have passed the initial screening. Technical Screening: The technical team then prepares a matrix of the particular requirements and required experience for the position and using a list of questions and the results, re-validates the candidates' technical skills. Background Check: Administrative personnel will provide a detailed background check, as required, per client agreement. On board: On successfully completing the above steps, the candidates are welcomed on board and assisted to ensure a smooth integration at the client's location. Position Details: Job Title: Technical Writer- Senior Location: Raleigh, NC Duration: 6 Months Project Description: Typical Experience: 60-84 months Expected Skills: Able to work without assistance; can provide leadership to others; able to manage complex work efforts; may have advanced education; may have deep industry experience Job Description: Description (including, but not limited to): · Translating technical information into clear, concise documents to be used by technical and non-technical personnel · Developing and/or maintaining the following types of documentation: communications for diverse stakeholder groups; system documentation and release notes; user manuals and training guides; installation guides; computer operations and program maintenance manuals; plans for training, testing, quality assurance, and contingency operations; backup, recovery and restart procedures; proposals, presentations, reports, standard operating procedures (SOP), policies and procedures · Editing of special reports or any other deliverables and documents Project-specific Requirements Required Skills - Must enjoy writing and be capable of expressing thoughts, concepts and technological situations to a non-technical reader in concise, succinct and clear language. Proven web content development experience. Ability to deliver - System Manual, User Manual and System Specifications and other documents as needed. Proficiency with MS Office products such as Word, Excel and SharePoint. Preference: Proficiency with MS Visio and PowerPoint. English degree with technology understanding. Education and/or government experience. Skills: Capable of expressing thoughts, concepts and technological situations to a non-technical reader in concise, succinct and clear language. Proven web content development experience (written content, not programming). Ability to deliver - System Manual, User Manual and System Specifications and other documents as needed. Proficiency with MS Office products such as Word, Excel and SharePoint. Proficiency with MS Visio and PowerPoint. Preference: English degree with technology understanding. Preference: Education and/or government experience. Additional Information All your information will be kept confidential according to EEO guidelines.

Infojini Consulting is a full service IT consulting, services, and staffing firm with offices in Secaucus, NJ. Infojini Consulting is recognized as one of the fastest growing IT services and software development Companies. With a partnership of all major technology vendors, Infojini Consulting has built a strong Government and commercial customer base including fortune 100 companies and most state and federal agencies such as State of North Carolina, State of South Carolina, State of Maryland, State of California, State of Pennsylvania, State of Virginia, State of Washington and many others. Infojini Consulting is an equal opportunity employer and considers all qualified individuals for employment irrespective of their race, gender, age, color, sexual orientation. We offer an excellent compensation package We are looking for Sr. Technical Writer in Raleigh, NC for 3+ months contract position. Please refer someone else if you are not available at this time or you are not right match for this job opportunity. We have great Referral Bonus up to $2500!!! Please don't miss to refer someone who are looking for projects. Job Description: Position: Sr. Technical Writer Location: Raleigh, NC Duration: 3+ months Client: Direct Client Required Skills: Documented experience in developing IT Operational processes and Procedure Experience meeting with managers to gather information on current processes to effectively document the process Knowledge of IT Service Delivery(network connectivity, desktop support, hosting services, etc.) and the ability to translate and document the process. Additional Information All your information will be kept confidential according to EEO guidelines.

The Grant Specialist plays a key role on the Development Team, responsible for preparing grant applications, compiling and submitting reports for foundations and other funders, and supporting other grantmaking efforts. This role works closely with staff across departments to collaborate on applications and conduct grant research that advances NeighborHealth Center's (NHC) vision, mission, goals, and programs. NHC has an established grants program with support from our local community of foundations, corporations, and faith partners. This position supports the fundraising efforts of NeighborHealth Center, and is responsible for managing, maintaining, and enhancing the effectiveness of NHC's grant writing efforts, including funder research and relationship cultivation. The position also provides oversight into timely management of grant applications and reporting on grant awards, working collaboratively with the Director of Development, Finance & Accounting department, and Clinic Liaison staff. The role collaborates with team members on events and other fundraising activities as needed. Principal Duties and Responsibilities* Work closely with the Director of Development to ensure all grant activity supports NHC's vision, mission, goals, and programs. Assist in managing the organization's grant calendar and collaborate with the Donor Database & Development Coordinator to maintain accurate opportunity documentation within RENXT (database). Develop and maintain a strong knowledge of NHC's history, programs, and budgets to make the best possible case for support. Coordinate the full life cycle of grants - writing and assembling proposals and supporting materials for submission to individuals, foundations, and corporations to meet NHC's operating and program needs. Collect and maintain filing system of grant supporting documentation Partner with the finance team and clinic program managers to ensure fiscal compliance, track restricted funds, and document expenses. Work with clinic program managers to implement evaluations, measure outcomes, and communicate impact to funders. Document required metrics and establish systems to ensure accurate data collection in collaboration with finance and clinic program managers. Steward a portfolio of grant funders and collaborate with Director of Development on cultivation activities and Donor Database Coordinator on documenting interactions and strategies. Conduct prospect research to identify and analyze potential new funding opportunities. Contribute to the preparation and management of the annual grants portfolio. Represent NHC at community events, as needed. Attend regular team meetings to provide updates and status reports. Assist with other fundraising projects as needed, including special events and other cultivation and community awareness activities. Assist with short- and long-range development planning activities to create and implement fund-raising goals and objectives Perform supportive administrative functions as needed. Other duties and responsibilities as needed and assigned. Requirements Required Skills or Abilities* Professional fundraising experience in the nonprofit sector. Demonstrated record of having prepared successful grants and proposals. Excellent written and oral communication skills, including ability to communicate in a compelling and succinct manner. Strong ability to plan, organize, prioritize, and coordinate multiple projects with initiative and time management skills to meet deadlines consistently. Meticulous attention to detail with proven ability to identify inconsistencies, ensure accuracy in documentation and deliverables, and maintain high-quality standards under tight deadlines. Ability to maintain confidential donor information. Ability to work independently and with a team. Ability to cultivate and develop inclusive and equitable working relationships with co-workers and community members Ability to serve as an advocate for individuals of all ethnicities, genders, ages, and backgrounds Computer literacy in internet use and Microsoft Office suite tools Preferred Skills and Abilities - Familiarity with healthcare grantors in the region and nationally is a plus. - Project management experience preferred. Required Knowledge, Experience, or Licensure/Registration At least three years of relevant experience in prospect research, grant proposal writing, data collection and analysis, budget creation/management, and reporting Ability to work onsite/hybrid Mondays through Fridays during the hours of 8am and 5pm with occasional hours outside this timeframe If working remotely, ability to work via a home office set up with access to secure Internet connection Ability to read, write, speak, and comprehend English fluently Preferred Knowledge and Experience - Undergraduate degree - Non-profit experience - Experience working with Raisers Edge or comparable CRM platforms. Physical requirements of the Job* Sitting or standing (often for prolonged periods) Carrying or lifting objects up to 20 pounds This is a full-time, non-exempt position. *To comply with the Americans with Disabilities Act of 1990 (ADA), which prohibits discrimination against qualified individuals on the basis of disability, it is necessary to specify the physical, mental and environmental conditions of the essential duties of the job. NeighborHealth Center is an Equal Opportunity Employer. NHC is dedicated to building a culturally diverse staff committed to serving a diverse patient population. We encourage applications from women, minority groups, veterans, and people with disabilities.

The North Carolina Clean Energy Technology Center (NCCETC), at N.C. State University advances a sustainable energy economy by educating, demonstrating and providing research and technical support for clean energy technologies, practices, and policies. This mission is accomplished through work in the following major program areas; Renewable Energy, Clean Power & Energy Efficiency, Clean Transportation, Green Building, Economic Development, Energy Policy, Workforce Development and Education & Outreach. The N.C. Clean Energy Technology Center serves as a resource for innovative, clean energy technologies through demonstration, technical assistance, outreach and training. More information about NCCETC is available at ***************************** Wolfpack Perks and Benefits As a Pack member, you belong here, and can enjoy exclusive perks designed to enhance your personal and professional well-being. As you consider this opportunity, we encourage you to review our Employee Value Proposition and learn more about what makes NC State the best place to learn and work for everyone. What we offer: * Medical, Dental, and Vision * Flexible Spending Account * Retirement Programs * Disability Plans * Life Insurance * Accident Plan * Paid Time Off and Other Leave Programs * 12 Holidays Each Year * Tuition and Academic Assistance * And so much more! Attain Work-life balance with our Childcare benefits, Wellness & Recreation Membership, and Wellness Programs that aim to build a thriving wolfpack community. Disclaimer: Perks and Benefit eligibility is based on Part-Time or Full-Time Employment status. Eligibility and Employer Sponsored Plans can be found within each of the links offered. Essential Job Duties The North Carolina Clean Energy Technology Center (NCCETC) seeks a highly organized and experienced Pre-Award & Post-Award Contracts and Grants Specialist to manage all aspects of sponsored research administration. In this role you will serve as the primary contact for the Center, which requires a deep understanding of federal, state, and university regulations to ensure compliance and successful project execution. As the primary contact, you will provide independent and comprehensive financial and administrative management of the Center's sponsored projects (Ledger 5 accounts). This includes supporting proposal submissions, overseeing financial compliance, and advising Principal Investigators and Center staff throughout the lifecycle of sponsored projects. You will apply your knowledge of federal (2 CFR 200), state, and NCSU guidelines to proactively deliver sound financial forecasting, ensure compliance, and support successful sponsored project administration. Key responsibilities fall within the 4 primary focus areas outlined below: Pre-Award Support: * Lead and coordinate proposal submissions from initial concept through final submission * Support Principal Investigators with budget development, cost proposals, and budget justifications * Draft and manage receipt-based service contracts and subcontracts; process fee-for-service invoicing * Review sponsor requirements to ensure proposals align with federal, state, and University guidelines * Manage pre-award activity in required systems (e.g., PINS, Grants.gov, agency submission platforms) Post-Award Financial Management & Compliance: * Manage the financial oversight of active grants and contracts to ensure accuracy and compliance * Monitor budgets, reconcile accounts, and review expenses in accordance with 2 CFR 200 and NCSU policies * Prepare financial, variance, and forecasting reports to support project planning and decision-making * Review expenditures, travel, and reimbursements for allowability and compliance * Process effort and cost-share reporting and maintain required documentation * Support award modifications, including re-budgeting, extensions, and funding adjustment Award Administration & Close-Out: * Administer sponsored projects from award setup through close-out * Ensure timely and accurate close-out of awards, including final financial reviews and approvals * Maintain documentation and internal controls that support compliance and audit readiness. Collaboration & Advisory Support: * Serve as a primary administrative resource for Principal Investigators and Center staff * Act as a liaison with sponsoring agencies, college partners, SPARCS, and central research offices * Provide guidance on administrative processes, allowable costs, and sponsored project requirements * Support onboarding and training of Center staff on research administration practices If you are a highly organized, detail-oriented research administration professional who enjoys supporting faculty, navigating compliance requirements, and delivering strong financial stewardship across sponsored projects, we encourage you to apply. Other Responsibilities In addition to the core responsibilities of this role, there will be occasional opportunities to take on additional duties. A few of those are listed below, this list is not exhaustive: * Assist and serve as back-up to the Center Finance & Business Manager on accounting matters, including as Pcard reconciler. * May serve as a Pcard holder for sponsored project related expenses and as backup to the Center Finance & Business Manager These and other additional duties offer an opportunity to build on your skills, explore new areas, and gain a deeper understanding of the department's operations. Qualifications Minimum Education and Experience Requires post-baccalaureate credentials or a bachelor's degree plus two years of related experience, or equivalent professional training and experience may be substituted for the advanced degree on an exceptional basis. Other Required Qualifications * Demonstrated experience in contract and grant administration within a university or non-profit research setting * Solid knowledge of federal and agency regulations, including Uniform Guidance (2 CFR 200) and FAR * Proficiency with research administration systems and sponsor submission platforms (e.g., PINS, RED, Grants.gov, Research.gov, PeopleSoft Financials) * Strong financial and analytical skills to manage complex project budgets, forecasting, and reporting * Excellent written and verbal communication to effectively convey regulatory and financial guidance to faculty and staff * Ability to work independently and collaboratively, demonstrating initiative, reliability, and sound judgment Preferred Qualifications * Advanced degree in a relevant field (e.g., business, finance, public administration, or a STEM discipline) * 5+ years of experience in research administration or grant/contract management, including interpreting sponsor announcements and preparing budgets or proposals * Familiarity with clean energy policy, contracts, or renewable energy research projects * Knowledge of state-funded grants and foundation funding practices * Experience mentoring or training staff in research administration processes Required License(s) or Certification(s) n/a Valid NC Driver's License required No Commercial Driver's License required No

This is Priya Sharma from US IT solutions Inc. and we are Staffing Specialist working directly with all US States and Local and Commercial clients. We are known for our IT Services, Mobile development, Web development and Cloud computing and working with clients to deliver high-performance results. This is Priya Sharma from US IT solutions Inc. and we are Staffing Specialist working directly with all US States and Local and Commercial clients. We are known for our IT Services, Mobile development, Web development and Cloud computing and working with clients to deliver high-performance results. If interested, Kindly call me on 408-766-00 - 00 Ext 431 Job Description Experience and proficiency in using HP test tools including Test Director/Quality Center 9.0 or higher and Quick Test Professional (QTP) 9.5 or higher Experience testing web, GUI, client/server, and database applications. Experience with requirements analysis and automated test cases/script development. Experience with manual or automated testing, testing tools, writing test plans and reviewing test cases. Qualifications Duties include analyzing business requirements for testability and completeness using Functional Specification Documents, Business Requirements Documents and Technical Design Documents, developing requirements into test conditions, cases and scripts, development and execution of automated scripts using HP Quality Center to thoroughly test software to ensure proper operation and freedom from defects. This position is responsible for reviewing test cases and other testing artifacts to ensure the accuracy and completeness of all test artifacts. This position coordinates testing, reports and tracks testing problems by providing reproducible test cases, works with other product team members to diagnose and recreate problems as well as prioritize and implement solutions and close problem reports. This position is responsible for test scripting data collection and analysis according to the project plan schedule and ensuring adherence to standard practices and procedures. Additional Information Thanks & Regards Priya Sharma ************ Ext 431

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Job Description We are looking to fill multiple positions for Technical Writing role writes, or supports the development of, various technical documents such as: requirements, specifications, test plans, and user manuals. Major Role Responsibilities: Understands validation concepts in order to produce documentation for validated systems; Provides evidence of compliance with legal, business and regulatory requirements; Translates highly technical software functions/features into process driven user friendly materials to support implementation and training of applications; Liaises with clients or developers to gather information; Organizes, synthesizes medical and business literature, and writes clear, accurate reviews of the literature. Creates operational and system qualification documentation in support of Messaging Services implementation. Develops Standard Operating Procedures (SOPs), training materials, and user manuals. Qualifications Years of experience: 1-3 years Additional Information In person interview is acceptable.

Preferred Qualifications Prior knowledge of post-award grant administration and budget practices Must be capable of working independently as well as part of a team Work Schedule Monday -Friday , 8:00 am- 5:00 pm

NC FAST P4 Test Scripts Writer Duration :12 + Months Rate : $28/hr on C2C Short Description: NC FAST requires the services of 2 Test Scripts Writers to support development and implementation of NC FAST Project 4 modules. Complete Description: The NC Department of Health and Human Services seeks contractor resources to assist with the development and implementation of NC Families Accessing Services through Technology (NC FAST) as a Test Scripts Writer. Duties include analyzing business requirements for testability and completeness using Functional Specification Documents, Business Requirements Documents and Technical Design Documents, developing requirements into test conditions, cases and scripts, development and execution of automated scripts using HP Quality Center to thoroughly test software to ensure proper operation and freedom from defects. This position is responsible for reviewing test cases and other testing artifacts to ensure the accuracy and completeness of all test artifacts. This position coordinates testing, reports and tracks testing problems by providing reproducible test cases, works with other product team members to diagnose and recreate problems as well as prioritize and implement solutions and close problem reports. This position is responsible for test scripting data collection and analysis according to the project plan schedule and ensuring adherence to standard practices and procedures. Additional Information All your information will be kept confidential according to EEO guidelines.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities * Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client. * Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. * Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. * Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed. * Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. * Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs. * Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. * Performs online clinical literature searches and complies with copyright requirements. * Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities. * Mentors and leads less experienced medical writers on complex projects, as necessary. * Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. * Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. * Completes required administrative tasks within the specified timeframes. * Performs other work-related duties as assigned. * Minimal travel may be required (less than 25%). At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $0.00 - $0.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management** + Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. + Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. + Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. + Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. + Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. + Keep client and team informed of project status. + Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. + Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. + Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. + Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. + Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed. **Client** **Liaison/Service** + Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management. + Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. + Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management. + Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management. + If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects. **Training/Compliance** + Keep abreast of new advances in medical writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management. + Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate. + Develop and present external training courses. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform + Analyze efficiency of work and discuss improvement ideas with Medical Writing + Services management and colleagues, e.g., evaluation of software to increase productivity and document quality. **Skills:** + Excellent interpersonal, negotiation, verbal, and written communication skills. + A flexible attitude with respect to work assignments and new learning. + Motivation to work consistently in a fast-paced, rapidly changing environment. + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects. + Knowledge of resource management and productivity metric management. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Ability to travel. + Fluent in written and spoken English. **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Grant Specialist plays a key role on the Development Team, responsible for preparing grant applications, compiling and submitting reports for foundations and other funders, and supporting other grantmaking efforts. This role works closely with staff across departments to collaborate on applications and conduct grant research that advances NeighborHealth Center's (NHC) vision, mission, goals, and programs. NHC has an established grants program with support from our local community of foundations, corporations, and faith partners. This position supports the fundraising efforts of NeighborHealth Center, and is responsible for managing, maintaining, and enhancing the effectiveness of NHC's grant writing efforts, including funder research and relationship cultivation. The position also provides oversight into timely management of grant applications and reporting on grant awards, working collaboratively with the Director of Development, Finance & Accounting department, and Clinic Liaison staff. The role collaborates with team members on events and other fundraising activities as needed. Principal Duties and Responsibilities* * Work closely with the Director of Development to ensure all grant activity supports NHC's vision, mission, goals, and programs. * Assist in managing the organization's grant calendar and collaborate with the Donor Database & Development Coordinator to maintain accurate opportunity documentation within RENXT (database). * Develop and maintain a strong knowledge of NHC's history, programs, and budgets to make the best possible case for support. * Coordinate the full life cycle of grants - writing and assembling proposals and supporting materials for submission to individuals, foundations, and corporations to meet NHC's operating and program needs. * Collect and maintain filing system of grant supporting documentation * Partner with the finance team and clinic program managers to ensure fiscal compliance, track restricted funds, and document expenses. * Work with clinic program managers to implement evaluations, measure outcomes, and communicate impact to funders. * Document required metrics and establish systems to ensure accurate data collection in collaboration with finance and clinic program managers. * Steward a portfolio of grant funders and collaborate with Director of Development on cultivation activities and Donor Database Coordinator on documenting interactions and strategies. * Conduct prospect research to identify and analyze potential new funding opportunities. * Contribute to the preparation and management of the annual grants portfolio. * Represent NHC at community events, as needed. * Attend regular team meetings to provide updates and status reports. * Assist with other fundraising projects as needed, including special events and other cultivation and community awareness activities. * Assist with short- and long-range development planning activities to create and implement fund-raising goals and objectives * Perform supportive administrative functions as needed. * Other duties and responsibilities as needed and assigned. Requirements Required Skills or Abilities* * Professional fundraising experience in the nonprofit sector. * Demonstrated record of having prepared successful grants and proposals. * Excellent written and oral communication skills, including ability to communicate in a compelling and succinct manner. * Strong ability to plan, organize, prioritize, and coordinate multiple projects with initiative and time management skills to meet deadlines consistently. * Meticulous attention to detail with proven ability to identify inconsistencies, ensure accuracy in documentation and deliverables, and maintain high-quality standards under tight deadlines. * Ability to maintain confidential donor information. * Ability to work independently and with a team. * Ability to cultivate and develop inclusive and equitable working relationships with co-workers and community members * Ability to serve as an advocate for individuals of all ethnicities, genders, ages, and backgrounds * Computer literacy in internet use and Microsoft Office suite tools Preferred Skills and Abilities * Familiarity with healthcare grantors in the region and nationally is a plus. * Project management experience preferred. Required Knowledge, Experience, or Licensure/Registration * At least three years of relevant experience in prospect research, grant proposal writing, data collection and analysis, budget creation/management, and reporting * Ability to work onsite/hybrid Mondays through Fridays during the hours of 8am and 5pm with occasional hours outside this timeframe * If working remotely, ability to work via a home office set up with access to secure Internet connection * Ability to read, write, speak, and comprehend English fluently Preferred Knowledge and Experience * Undergraduate degree * Non-profit experience * Experience working with Raisers Edge or comparable CRM platforms. Physical requirements of the Job* Sitting or standing (often for prolonged periods) Carrying or lifting objects up to 20 pounds This is a full-time, non-exempt position. * To comply with the Americans with Disabilities Act of 1990 (ADA), which prohibits discrimination against qualified individuals on the basis of disability, it is necessary to specify the physical, mental and environmental conditions of the essential duties of the job. NeighborHealth Center is an Equal Opportunity Employer. NHC is dedicated to building a culturally diverse staff committed to serving a diverse patient population. We encourage applications from women, minority groups, veterans, and people with disabilities.

We are from US IT Solutions, an ISO Certified, E-Verify, WMBE Certified organization established in 2005 in CA. Our company is serving various State, Local and County Departments for over 10 years. USITSOL has been helping clients innovate across all phases of the application lifecycle for over a decade. Some of our prestigious clients are State of CA, State of OR, State of FL, State of NC, State of GA, State of CO, State of VA, State of AR, State of MI, State of OH, State of IL, State of MO, State of MS, California State University, Sacramento Area Sanitation Department, SMUD, Sound Transit, LA Superior Courts, District of Columbia, UMAS, University of Central Florida and Hennepin County and many more. Job Description Title/ Designation: Test Scripts Writer Duration 12 Months Location: Durham, NC Description: Duties include analyzing business requirements for test ability and completeness using Functional Specification Documents, Business Requirements Documents and Technical Design Documents, developing requirements into test conditions, cases and scripts, development and execution of automated scripts using HP Quality Center to thoroughly test software to ensure proper operation and freedom from defects. This position is responsible for reviewing test cases and other testing artifacts to ensure the accuracy and completeness of all test artifacts. This position coordinates testing, reports and tracks testing problems by providing reproducible test cases, works with other product team members to diagnose and recreate problems as well as prioritize and implement solutions and close problem reports. This position is responsible for test scripting data collection and analysis according to the project plan schedule and ensuring adherence to standard practices and procedures Qualifications Skills: Experience and proficiency in using HP test tools including Test Director/Quality Center 9.0 or higher and Quick Test Professional (QTP) 9.5 or higher Experience testing web, GUI, client/server, and database applications. Additional Information Experience with requirements analysis and automated test cases/script development Experience with manual or automated testing, testing tools, writing test plans and reviewing test cases.