Medical writer jobs in Durham, NC - 59 jobs

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.

Acts as Lead Medical Writer on any type of writing project and can advise others on any type of document. Can act in a customer account management capacity and present, discuss, and answer questions on overall Medical Writing global capabilities to prospective customers. Performs Senior Review of all types of medical writing deliverables. Provides feedback and guidance to staff and identifies and acts upon department training needs. Communicates various medical writing topics to a broad audience and identifies appropriate parties to be included. Negotiates timelines and discusses/resolves customer comments. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practices (GCP), along with developments and advances in drug development/medical and/or technical writing. Essential Functions Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer. Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests. Use experience and initiative to tackle new/unusual document types and customer requirements. Chair meetings and resolve conflict using advanced negotiation and conflict resolution skills. Prepare, present and respond in bid defense meetings and discussions. May design training materials and input into generic training plans for staff. Proposes topics for and prepares and delivers knowledge-sharing sessions for the global team. May plan and deliver workshops or presentations on Medical Writing topics, e.g. for a conference. May act as project manager for a large Medical Writing program, including more than one document type and/or region and/or limited other functions. May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, customer liaison, and tracking. Complete project finance activities, including monitoring and forecasting budgeted hours. Independently propose, review and approve budgets and assumptions for a range of project types within remit. May take on a larger partnership lead role. May propose and/or lead small global Medical Writing initiatives or act as a regional Medical Writing representative on a cross-functional initiative. May represent Medical Writing as reviewer for cross-functional Standard Operating Procedures (SOPs) owned by other operations. May make process improvements to enhance performance. Qualifications Bachelor's Degree Bachelor's Degree in life sciences related discipline or related field Master's Degree Master's Degree in life sciences related discipline or related field Ph.D. Ph.D. in life sciences related discipline or related field Typically requires at least 8 years of highly relevant experience and related competency levels. In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in documents. Good understanding of common statistical methods used in clinical trials and/or interpretation of their results. Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output. Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. Req Extensive experience in preparing CSRs and protocols independently to a consistently high standard, regardless of complexity or challenges. Req Experienced in preparing CTDs and/or tackling new/unusual document types/customer requirements. Pref In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas. Req Excellent written and oral communication skills including grammatical/technical writing skills. Excellent attention to detail and accuracy. Confident and effective communication and negotiation skills with customers and project managers. Ability to set a positive example to staff in attitude to customers and colleagues and communication style. Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues. Demonstrated ability to handle unfamiliar situations or document deliverables. Demonstrated abilities in collaboration with others and independent thought. Demonstrated ability to influence others in global and/or cross-functional or customer discussions. Demonstrates good judgement in requesting input from senior staff. Ability to establish and maintain effective working relationships with coworkers, managers and customers at a senior level. Experienced and effective in providing feedback and guidance to staff. Ability to effectively manage multiple tasks and projects. Decisive amongst competing priorities. Confident in raising and discussing sensitive topics without management intervention. Ability to proactively identify potential issues affecting other functions on the project teams and facilitate appropriate communication Identifies creative solutions to challenges that are acceptable to IQVIA and customers. Must be computer literate. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $99,200.00 - $276,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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-LO1 \#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.

At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. **Job Title: Endpoint Security Senior Technical Writer** **Job Description:** We are looking for a dedicated and skilled Senior Technical Writer to join our cybersecurity team. The ideal candidate will be responsible for creating, maintaining, and enhancing documentation that supports the planning, implementation, and operational readiness of multiple endpoint security initiatives. This role requires exceptional writing skills, a strong understanding of cybersecurity concepts, and the ability to collaborate closely with technical subject matter experts to produce clear, accurate, and standardized documentation. **Key Responsibilities:** 1. **Documentation Development:** 1. Develop, revise, and maintain high-quality documentation for cybersecurity technologies, processes, and workflows. 2. Create standard operating procedures (SOPs), implementation guides, engineering runbooks, and architectural overviews. 3. Produce documentation for system requirements, architecture designs, and operational readiness for new and existing solutions. 2. **Content Accuracy & Compliance:** 1. Ensure all documentation reflects current tools, configurations, and organizational standards. 2. Support documentation needs for compliance audits, risk assessments, and onboarding materials. 3. Align outputs with established documentation templates and governance frameworks. 3. **Collaboration & Knowledge Transfer:** 1. Work closely with cybersecurity SMEs, engineering teams, and operations to gather technical details and translate them into clear, user-friendly content. 2. Facilitate knowledge continuity by creating materials that enable smooth handoffs between teams. 4. **Continuous Improvement:** 1. Identify gaps in existing documentation and propose enhancements. 2. Stay informed on cybersecurity trends and incorporate best practices into documentation processes. **Qualifications:** + Strong technical writing skills with demonstrated ability to create clear, concise, and user-focused documentation. + Experience in cybersecurity or IT infrastructure environments, with familiarity in topics such as endpoint protection, SIEM, identity management, and cloud security. + Proficiency in documenting system requirements, architecture diagrams, SOPs, and implementation guides for technical audiences. + Excellent interviewing and collaboration skills to work with subject matter experts, engineers, and project stakeholders. + Familiarity with documentation tools and platforms, such as Confluence, SharePoint, Google Workspace, or equivalent. + Ability to interpret and standardize technical content, applying consistent tone, structure, and formatting across documents. + Understanding of documentation standards and style guides + Version control and change tracking awareness, including using tools like Git, document repositories, or structured file naming/versioning systems. + Experience in the utility sector, with an understanding of industry-specific terminology, operations, or regulatory environments. + Experience developing documentation specific to cybersecurity technologies used to protect systems within the utility vertical. + Experience in creating secure configuration and hardening guides for technologies used in utility environments (e.g., Windows, Linux, firewalls, etc.) + Familiarity with cybersecurity frameworks and standards, including NIST 800-53, NIST Cybersecurity Framework (CSF), ISA/IEC 62443, or ISO/IEC 27001. + Experience documenting critical infrastructure protection strategies, including risk assessments and vulnerability management programs. + Understanding of cybersecurity standards and ability to translate compliance and regulatory language into practical documentation. **What we offer you** At EY, we'll develop you with future-focused skills and equip you with world-class experiences. We'll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn more . + We offer a comprehensive compensation and benefits package where you'll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $77,500 to $140,900. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $92,900 to $160,500. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. + Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year. + Under our flexible vacation policy, you'll decide how much vacation time you need based on your own personal circumstances. You'll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being. **Are you ready to shape your future with confidence? Apply today.** EY accepts applications for this position on an on-going basis. For those living in California, please click here for additional information. EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities. **EY | Building a better working world** EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law. EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY's Talent Shared Services Team (TSS) or email the TSS at ************************** .

This role is ideal for someone who: + Is a meticulous reader and writer with a drive to learn about cloud technology at a national scale. + Can interpret expert input to craft proposal content that is informative _and_ persuasive. + Takes pride in the writing they produce and is always looking for ways to hone their craft. + Possesses knowledge and experience with any of public cloud providers including Oracle, Amazon Web Services (AWS), Azure or Google (GCP) architecture, tools, and cloud methodologies. As a Technical Proposal Writer, you will be responsible for: + Writing technical proposals for US federal government customers seeking Oracle Cloud services and task order solutions. + Capturing and organizing content and knowledge from subject matter experts across Oracle and presenting it in clear, compliant, compelling format for technical and non-technical audiences. + Understanding, identifying, and documenting client requirements and driving compliance with those requirements across internal response teams. + Becoming an internal expert on Oracle GDI's proposal process. + Actively identify team process enhancements and work with team members to implement them. + Support response teams in online and in-person efforts to ensure the written components of the proposals are compelling and aligned. + Managing multiple versions of documents across separate systems, including maintaining current working documents throughout the proposal drafting process. + Employing superior written and verbal communication skills with attention to grammar, formatting, term consistency, and adherence to Oracle writing practices. **EXPERIENCE** **_Required_** + Minimum of four years' experience working in industry as a technical writer. **_Desired_** + Minimum of six years' experience working in industry as a technical writer. **EDUCATION AND CERTIFICATIONS** **_Required_** + Bachelor's degree, any discipline. **_Desired_** + APMP Foundation Level Certification or higher. **Security Clearance:** + Candidates will need to be able to obtain and maintain a Secret / Top-Secret Security Clearance to work with the US Federal government _This is a remote position with the candidate willing to travel to the Reston, VA Office a few times quarterly._ **Responsibilities** Responsible for participating in customer engagements to collaboratively design and implement solutions. Displays product/application understanding through more customized presentation demonstrations to customers and at conferences and events. May work directly with customers to gather requirements, develop architectures and translates business needs into solutions. Implements solutions and ensures successful deployments through code development and scripting. Supports customer from Proof of Concept (POC) through production deployment of services via resource configuration, planning, and customer education/training. Creates and distributes technical assets (white papers, solution code, blog posts, and video demonstrations). Serves as a technical point of contact for customers and sales on technical cloud solutions and customer success. Further builds business and technical acumen. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from $37.88 to $60.63 per hour; from: $78,800 to $126,100 per annum. May be eligible for equity. Eligible for commission with an estimated pay mix of 70/30. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC2 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

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.

Collabera Inc (Staffing Firm). We are based out of Morristown, NJ and we have been providing contingent labor to our clients for last 25 years. In 2015 we placed more than 6,000 contractors across select 100+ clients that we service. End client for this project is a large legal organization with operations in more than 100 countries and has more than 50,000 employees around the world. For eight consecutive years, Fortune has named this company as World's ‘Most Admired Companies to work for'. Job Description Position Details: Client: Cisco Systems Job Location: RTP, NC Job Title: Role: Technical Writer III (CSCOJP00040455) Job Duration: 12 -18 months+ The Development Licensing Office at Cisco perform centralized development of a new Cloud-Based Software Licensing Platform, licensing libraries, APIs, and policies. Our Primary Projects include a standardized software plugin that operates in all Cisco products, Test Harness Systems, and on prem License Managers. If you have ever wanted a role that touches EVERYTHING Cisco develops, this is it. This opening is for a person to write technical software manuals, appendices, operating and maintenance instructions. Gather and research information for use in technical documentation. • Strong command of English (business) language a MUST • Prior experience writing Cisco documentation strongly desirable Responsibilities: • Be part of the Agile Scrum Team: attend daily stand-up meetings • Excellent Written and Verbal Communication skills are must. • Document features and requirements for Smart Licensing products • Work with Engineers to covert concepts and work flows into review content • Work with Engineers, Product owners and management to create needed external product documentation Qualifications Current working knowledge and Minimum Requirements: • 7 years of experience writing technical documentation required. • Experience writing technical documentation for software products. • Astoria Content Management System • XMetaL XML Editor • Word, PDF Additional desired skills: • Ability to learn quickly and critically • Previous experience with Cisco product portfolio a plus • Experience working in Agile development environment Additional Information If interested and want to apply, please contact: Rudra Mukherjee ************

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.

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.

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.

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 a position for Technical Writer for IT Service Delivery domain in Raleigh NC. Qualifications Atleast 5 years of relevant experience documenting in developing IT Operational processes and Procedure 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

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 complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and 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. * Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained. * Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately. * Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained. * 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 relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Works with staff across company to advance company priorities. * Performs online clinical literature searches and complies with copyright requirements. * Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Contributes to changes to internal process, standard practices, and capabilities. * Mentors and leads less experienced medical writers on complex documents. * Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Engages externally with industry groups on industry initiatives. * Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Contributes to bid projections. * Communicates status and changes to medical writing leadership; negotiates timelines and assigned deliverables. * Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects. 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 Principal medical writer on clinical study or regulatory project teams. Provides scientific writing, regulatory guidance, and technical expertise in the writing, production, and review of high-quality complex regulatory and other scientific/clinical documents, ensuring that clinical data is presented in documents in compliance with applicable regulatory guidelines. May guide the work of junior writers.

Join us as a Program Manager within our Regulatory Medical Writing team where you will make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Regulatory Medical Writing Program Manager, you will lead client programs with high visibility among internal and client teams, often requiring a high degree of client engagement and management; manage client relationships and identify and resolve client management issues; manage and ensure the timely delivery and the quality of multiple program documents; develop, monitor, and adapt project plans, client and program-specific processes, timelines, and budgets/forecasting for programs. You will also serve as subject matter expert for assigned programs. What You'll Do: Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications. Assist business development and senior management on securing new business at program levels by developing and making presentations to clients, leading the development and review of proposal texts and budgets, and supporting contract negotiations. Serve as point of contact for risk escalation for assigned programs. Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline. Ensure compliance with quality processes and requirements for assigned programs both within and between documents within a project. Develops, reviews and manages performance metrics for assigned projects. Provide training for medical writers on processes and technical aspects of program management. May serve as backup medical writer. Duties could include researching, writing and editing clinical study reports and protocols, summarizing data from clinical studies, writing or providing input on complex clinical and scientific documents such as IBs, INDs, and MAAs, and providing senior review of project materials. Education and Experience Requirements: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Experience in managing and directing complex medical writing projects required Experience working in the pharmaceutical/CRO industry preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Solid program management skills to include budgeting, forecasting and resource management Extensive knowledge of global, regional, national and other document development guidelines In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc. Excellent interpersonal, oral and written communication, and presentation skills Excellent negotiation skills Self-motivated and adaptable Excellent judgment; high degree of independence in decision making and problem solving Capable of mentoring and leading junior level staff Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference. Apply today to help us deliver tomorrow's breakthroughs.

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.

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

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.