Medical writer jobs in Cary, NC

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

**Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada.** Job Purpose: The Medical Writer, Medical Writing, is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality. This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, Sponsor SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company's objectives. Key Accountabilities: Oversight of activities - Write and edit clinical regulatory documents for clarity, and accuracy according to Sponsor standards. - Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives. - Provide writing support for a wide range of documents, including but not limited to investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. - Ensure that documents comply with International Conference on Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices. Collaborative relationships - Collaborates effectively with lead writers and project teams to develop and refine clinical regulatory documents that align with Sponsor standards, ICH guidelines, and Good Clinical Practices, ensuring clear and accurate communication of study data and objectives within submission timelines. Compliance with Parexel standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - At least 4 years of writing experience in the pharmaceutical industry - Experience with a variety of regulatory and clinical documents - Experience in a matrix team environment - Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents Knowledge and Experience: - Ability to write and edit complex material to ensure accuracy and clarity, - Excellent written and oral communication skills and demonstrated problem-solving abilities - Ability to handle multiple projects and short timelines - Ability to work cooperatively with colleagues in a wide range of disciplines Education: - BA/BS or higher \#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.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards. **What You Will Be Doing:** - Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity. - Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development. - Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards. - Mentoring and training junior medical writers, fostering a culture of excellence and professional growth. - Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs. **Your Profile:** - Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred. - Significant experience in medical writing, particularly in regulatory submissions and clinical documentation. - Strong understanding of regulatory requirements and industry standards for clinical writing. - Exceptional writing and editing skills, with a keen eye for detail and clarity. - Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders. - A commitment to maintaining high standards of quality and compliance in all medical writing activities. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

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. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards. What You Will Be Doing: • Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity. • Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development. • Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards. • Mentoring and training junior medical writers, fostering a culture of excellence and professional growth. • Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs. Your Profile: • Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred. • Significant experience in medical writing, particularly in regulatory submissions and clinical documentation. • Strong understanding of regulatory requirements and industry standards for clinical writing. • Exceptional writing and editing skills, with a keen eye for detail and clarity. • Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders. • A commitment to maintaining high standards of quality and compliance in all medical writing activities. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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.

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.

About the team: Capital Markets is part of Capco's DNA. In fact, the Capco name was inspired by this domain. The Capital Markets team delivers expert consulting skills and deep product and functional knowledge across all areas of the front office, operations, technology, risk, finance and compliance. Our clients include the largest investment banks, global universal banks and capital markets divisions from regional banks across the country and around the globe. Our delivery expertise spans across launching new lines of business, coordinating high-impact regulatory response programs, leading complex integration projects and analyzing the dependencies in an application rationalization effort. We have a consistent track record in helping clients with significant cost reductions and ensuring our clients grow, change and compete. About the Job: As a Senior Consultant at Capco you will be playing a key role in the delivery of projects and development of new business opportunities, working on client site to deliver change initiatives for leading clients across Financial Services, particularly the Capital Markets space. What You'll Get to Do: Create, update, and maintain Archiving Technology documentation including but not limited to product documentation, procedures, and technical documentation to support various compliance products and services within eDiscovery Services and Archiving Technology Organize complex information into logical, intuitive structures. Define documentation standards, templates, and style guides for consistency. Partner closely with eDiscovery, Archiving Technology and other business stakeholders to gather source information. Transform complex information into clear, user-friendly documentation Ensure documentation is technically correct, complete, and tested against actual product behavior. Create and update a central documentation repository in Confluence including maintain taxonomy, metadata, and version control. Ensure consistency and industry best practices are incorporated into the documentation artifacts. Enforce style, grammar, and clarity standards. Manage review processes with SMEs and stakeholders. What you'll bring with You: 5+ years of relevant experience in technical writing in a management consulting or financial services company. Exceptional writing skills: This is a fundamental requirement, encompassing clarity, conciseness, grammar, and the ability to simplify complex ideas Technical aptitude: Need to understand the underlying technical concepts of the product or subject being documented. Understand and translate complex technical concepts to a non-technical audience, and the ability to translate legal/regulatory processes and requirements to IT partners Strong research skills: The ability to effectively gather and analyze information from various sources is crucial Communication and interpersonal skills: Effective verbal and written communication is essential for collaborating with subject matter experts, team members, users, and other stakeholders at all levels. Bachelor's degree or a combination of education plus equivalent work experience preferably with a credentials in writing, e.g., communications, English Why Capco? A career at Capco is a chance to help reshape the competitive landscape in financial services. We launch new banks, transform existing ones, and help our clients navigate complex change. As consultants, we work on the front-end business design all the way through to technology implementation. We are the largest Financial Services focused consultancy in the world, serving everyone from global banks to emerging FinTechs, from strategy through digital transformation, design, business consulting, data and analytics, cyber, cloud, technology architecture, and engineering. Capco is a young and growing firm. We maintain an entrepreneurial spirit and growth mindset and have minimal bureaucracy. We have no internal silos that get in the way of your career opportunities or ability to focus on our clients and make a difference to the business. We offer the opportunity for everyone to learn rapidly, take on tough challenges, and get promoted quickly. We take pride in our creative, collaborative, diverse, and inclusive culture, where everyone can #BYAW. We offer highly competitive benefits, including medical, dental and vision insurance, a 401(k) plan, tuition reimbursement, and a work culture focused on innovation and creation of lasting value for our clients and employees. Ready to take the Next Step #LI-JC1

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.

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 ************

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.

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

Employment Type: Full-time, Contract M-F 8AM-4:30PM Pay Rate: $20.00 to 23.00 per hour We are looking for a Technical Writer to produce high-quality documentation that contributes to the overall success of our products and processes. You will join a team of talented engineers who work collaboratively with product managers, test engineers, quality engineers, and usability experts to make our products and processes easier to use. Duties and Responsibilities Create or revise product SOPs for RMA work. Creates, edits, and publishes documentation related to products, services, and processes. Analyze existing and potential SOPs, focusing on reuse and single-sourcing opportunities. Researches topics, writes documents, and edits their work for publication. Communicates complex technical information in a clear and concise manner - Written and visually. Work with internal teams to obtain an in-depth understanding of the product and the documentation requirements. Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience. Create and maintain the information architecture. Other assignments as needed to support overall business needs. Skills/Knowledge Requirements: Proven working experience in technical writing of IT documentation. Ability to deliver high quality documentation paying attention to detail. Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures. Excellent written skills in English. Strong working knowledge of Microsoft Office. PLEASE provide an updated resume and contact number Education and Experience · Bachelor's Degree in Electrical Engineering or similar field is preferred. · 3 years or more technical/SOP writing experience is preferred. About Foxconn Assembly, LLC Foxconn Assembly, LLC has always adhered to the production and operation strategy of "Deeply cultivated in China and Deployed globally", played the role of a bridge and link between domestic and foreign dual circulation, and vigorously promoted the digital transformation of the entire ICT industry chain. After several years of development, it has become a leading enterprise in the global digital economy. It ranks second in the world in the electronic manufacturing service industry, and continues to contribute to the high-quality development of the digital economy. World's 2nd largest electronic manufacturing service industry 30+ Fully automatic smart factories 190,000+ Global Employees

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.

As a Lead Medical Writer on most types of writing projects. You will prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Perform Senior Review of straightforward medical writing deliverables. Negotiate timelines and discusses/resolves customer comments. Provide written and verbal feedback to junior staff, and to customers when appropriate. Keep abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing. Responsibilities: Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus. Contributes to project plan concerning timelines as well as organization and table layout for a specific document. Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented. Review and edit documents for consistency, progression, structure, and grammar. Review statistical analysis plans and incorporate into clinical study reports or submission documents, as applicable. Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently. Participate in team and client meetings as requested. Deliverables above plus able to work independently on a range of complex clinical documents Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently Resolves complex problems independently Education and Experience required: 8+ years of experience in medical writing or related field Required - Bachelors Degree in Life Sciences or related field Preferred - Masters or PhD in Life Sciences or related field 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 $84,400.00 - $211,100.00. 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.

**Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada.** Job Purpose: The Medical Writer, Medical Writing, is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality. This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, Sponsor SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company's objectives. Key Accountabilities: Oversight of activities - Write and edit clinical regulatory documents for clarity, and accuracy according to Sponsor standards. - Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives. - Provide writing support for a wide range of documents, including but not limited to investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. - Ensure that documents comply with International Conference on Harmonization guidelines, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices. Collaborative relationships - Collaborates effectively with lead writers and project teams to develop and refine clinical regulatory documents that align with Sponsor standards, ICH guidelines, and Good Clinical Practices, ensuring clear and accurate communication of study data and objectives within submission timelines. Compliance with Parexel standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - At least 4 years of writing experience in the pharmaceutical industry - Experience with a variety of regulatory and clinical documents - Experience in a matrix team environment - Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents Knowledge and Experience: - Ability to write and edit complex material to ensure accuracy and clarity, - Excellent written and oral communication skills and demonstrated problem-solving abilities - Ability to handle multiple projects and short timelines - Ability to work cooperatively with colleagues in a wide range of disciplines Education: - BA/BS or higher \#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. 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%). Qualifications: * 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. 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 are responsible for writing and editing manuscripts and other medical communications on clinical studies and/or scientific reports including 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 such as screening, analyzing, and summarizing additional data from other sources as needed. Conducts systematic literature searches and reviews. Prepares literature for new products and revises existing medical communication. Reviews and analyzes statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. Supports engagement and interaction with regulatory agencies through preparation of briefing books and response documents to health authority questions. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.

Senior Proposals Writer - United States, Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Proposals Writer II to join our diverse and dynamic team. As a Proposals Writer II at ICON, you will play a pivotal role in crafting compelling and accurate proposals for clinical trials and research projects, ensuring they meet client requirements and regulatory standards. You will contribute to the advancement of innovative treatments and therapies through effective proposal development, supporting the successful acquisition of new projects and partnerships. What You Will Be Doing: Collaborating closely with cross-functional teams to gather information and insights for proposal development. Writing and editing high-quality proposals tailored to client specifications and requirements. Conducting thorough research and analysis to support proposal content and strategy. Managing multiple proposal projects simultaneously and adhering to strict deadlines. Ensuring proposals are compliant with internal standards and industry regulations. Your Profile: Bachelor's degree in life sciences, communications, or a related field. Minimum of 2 years of experience in proposal writing, technical writing, or a similar role. Excellent written and verbal communication skills, with meticulous attention to detail. Strong analytical and critical thinking abilities, with the capacity to synthesize complex information. Proficiency in Microsoft Office Suite and familiarity with proposal management software. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply