Must Haves:
1-3 years of experience in research administration, working in Higher Education, non-profit, or hospital settings with grants
Experience in a customer service role
Experience writing, reviewing, developing, editing, and creating budgets/budget narratives, as well as submitting proposals
Ability to read and review budgets, perform flight calculations, verify numbers, and complete Excel calculations
Proficiency in MS Office (Excel, Word, PDF, Teams) and familiarity with Banner, Cayuse, Streamlyne, Kuali, or InfoEd
Plusses:
CRA Certification
Knowledge of federal, state, and university grant programs that support research, instruction, and public service across disciplines and their submission process
Day-to-day:
Working closely with faculty, principal investigators, and project directors throughout the University and external agencies
Provide technical pre-and post-award support to principal investigators and project directors in the development, review and submission of all routine/complex grant and contract proposals by providing extensive information and guidance for use in the proposal submission process with a concentration on budgetary matters
Develop and maintain a schedule of funding cycles, proposal submissions, and reporting deadlines
Ensure that applicants are aware of and comply with applicable deadlines
Review completed proposal applications and contracts for accuracy, completeness, and compliance with the requirements of the University, the University System, and the prospective funding agency
Work with federal, state, and private funding entities-Develop and provide training on the administrative and financial requirements of the various awards as needed, as well as perform other duties as assigned.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: *************************************************** .
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
$39k-58k yearly est. 3d ago
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Principal Medical Writer (Regulatory MW)
Thermofisher Scientific 4.6
Medical writer job in Greenville, NC
**Principal MedicalWriter** At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our Medical Writing team is growing, and we are looking for a Principal MedicalWriter. This role is based in the United States.
**Discover Impactful Work:**
Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Regulatory Medical Writing documents, such as protocols, CSR, Investigator Brochures, and Marketing Applications, ensuring outstanding quality and compliance.
**A Day in the Life:**
+ Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
+ Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
+ As an essential advisory member of the writing team, may provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry best practices.
+ May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
**Keys to Success:**
+ Acts with intensity
+ Strong project management skills
+ Excellent interpersonal skills including problem solving and negotiation
+ Able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
**Education**
+ Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
**Experience**
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
+ Experience in managing and directing complex Regulatory medical writing projects required
+ Experience working in the pharmaceutical/CRO industry preferred
+ Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
**Knowledge, Skills, Abilities**
+ Significant knowledge of global, regional, national and other document development guidelines
+ Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
+ In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, marketing application submissions, communications, etc
+ Strong project management skills
+ Excellent interpersonal skills including problem solving and decision-making
+ Strong negotiation skills
+ Excellent oral and written communication skills with strong presentation skills
+ Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook); willingness to utilize technology to support authoring efficiency
**Benefits**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
**What We Offer:**
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture (***************************************** , where PPD clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (************************************************************************************** . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$74k-96k yearly est. 60d+ ago
Principal Medical Writer - Narrative Documents
Syneos Health, Inc.
Medical writer job in Morrisville, 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
* 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 medicalwriters 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 medicalwriter 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.
$71k-105k yearly est. 22d ago
Senior/Principal Medical Writer - USA
Trilogy Writing and Consulting
Medical writer job in Durham, NC
Trilogy Writing & Consulting, an Indegene Company, is hiring
Senior/Principal MedicalWriters
(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 MedicalWriter, 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 MedicalWriter.
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 MedicalWriter, 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 MedicalWriter, 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 MedicalWriter 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.
$120k-159k yearly 60d+ ago
Senior Medical Writer - FSP
Parexel 4.5
Medical writer job in Raleigh, NC
The Senior MedicalWriter 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 MedicalWriter 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.
$76k-112k yearly est. 13d ago
Senior Technical Writer
Contact Government Services, LLC
Medical writer job in Charlotte, NC
Senior Technical WriterEmployment Type: Full-Time, ExperiencedDepartment: Technology Support CGS is seeking an experienced Senior Technical Writer to provide consultative, analytical, and documentation support for a large Federal agency initiative. CGS brings motivated, highly skilled, and creative people together to solve the government's most dynamic problems with cutting-edge technology. To carry out our mission, we are seeking candidates who are excited to contribute to government innovation, appreciate collaboration, and can anticipate the needs of others. Here at CGS, we offer an environment in which our employees feel supported, and we encourage professional growth through various learning opportunities.
Skills and attributes for success:- Drafting and development of technical documentation related to a variety of projects in the IT space.- Work closely with project stakeholders to establish technical processes and procedures.- Document projects through the SDLC.- Provide status reports for multiple ongoing projects and related documentation efforts.- Assist with both user and admin level documentation.
Qualifications:- Excellent writing and Communication skills.- 5+ years experience with development of technical documentation.- 3+ years experience with development of user documentation.- Fluency with industry standard technical summary and reporting techniques including Agile project management methodology.- Ability to produce quality work independently or in a group setting.- Experience with MS Office Suite including Visio.- Willingness and ability to pass background check/security screening.
Ideally, you will also have:- Familiarity with Business Intelligence/Analysis applications.- Experience with Government software development policies and procedures.- Client facing communication experience.- Federal Agency issued security clearance.
Our Commitment:Contact Government Services (CGS) strives to simplify and enhance government bureaucracy through the optimization of human, technical, and financial resources. We combine cutting-edge technology with world-class personnel to deliver customized solutions that fit our client's specific needs. We are committed to solving the most challenging and dynamic problems.
For the past seven years, we've been growing our government-contracting portfolio, and along the way, we've created valuable partnerships by demonstrating a commitment to honesty, professionalism, and quality work.
Here at CGS we value honesty through hard work and self-awareness, professionalism in all we do, and to deliver the best quality to our consumers mending those relations for years to come.
We care about our employees. Therefore, we offer a comprehensive benefits package.- Health, Dental, and Vision- Life Insurance- 401k- Flexible Spending Account (Health, Dependent Care, and Commuter)- Paid Time Off and Observance of State/Federal Holidays
Contact Government Services, LLC is an Equal Opportunity Employer. Applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Join our team and become part of government innovation!
Explore additional job opportunities with CGS on our Job Board:**************************************** more information about CGS please visit: ************************** or contact: Email: *******************
#CJ
$61k-84k yearly est. Auto-Apply 60d+ ago
Proposal Writer - Heavy Civil Construction
Ames Construction 4.7
Medical writer job in Charlotte, NC
Ames Construction has built America for more than 60 years, and the exceptional people who make up our team are a vital factor in our success. We are a full-service, heavy civil and industrial general contractor that brings innovative solutions to many market segments, from highway and bridge construction to mining and rail. Ames is an employee-owned company that retains its entrepreneurial spirit while offering the experience and stability of a proven construction industry leader. Equipped with our core values of People, Team, Our Bond, Persistence, and Vision, we make communities across the U.S. safer, keep supply chains moving, and lay the groundwork for a sustainable future. By joining Ames, you will be working with talented colleagues at an award-winning, nationally recognized top 65 general contractor.
The Proposal Writer will be responsible for developing and managing high-quality, compliant, and compelling proposals in response to RFQs, RFPs, and SOQs for heavy civil construction projects. This role requires excellent communication and writing skills, a firm understanding of civil construction processes, and the ability to work collaboratively with internal teams and external partners.
Key Responsibilities:
* Review and interpret RFP/RFQ documents to develop compliant, client-focused responses.
* Write, edit, and organize proposal content including executive summaries, approach narratives, project descriptions, resumes, safety records, and organizational charts.
* Coordinate with estimating, operations, engineering, and business development teams to gather technical content and ensure proposal accuracy.
* Manage multiple deadlines, proposal schedules, and submission requirements.
* Maintain and update a library of boilerplate content, resumes, and project write-ups.
* Assist in developing presentations and marketing collateral as needed.
* Ensure all submissions align with client requirements and company branding.
Qualifications:
* Bachelor's degree in Communications, English, Civil Engineering, Construction Management, or a related field.
* 2-5 years of experience writing proposals in the heavy civil, construction, or AEC (Architecture, Engineering, Construction) industry.
* Strong writing, editing, and organizational skills with a keen attention to detail.
* Familiarity with public agency procurement processes (e.g., DOTs, municipalities, transit authorities).
* Proficient in Microsoft Office (Word, Excel, PowerPoint); knowledge of Adobe Creative Suite (InDesign, Illustrator) is a plus.
Preferred Skills:
* Experience preparing proposals for design-bid-build, design-build, progressive design-build, and CM/GC projects.
* Understanding of construction documents including schedules, cost estimates, and work plans.
* Ability to manage input from multiple stakeholders under tight deadlines.
Ames Construction is 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, or status as a protected veteran.
$54k-67k yearly est. Auto-Apply 54d ago
Test Scripts Writer
Us It Solutions 3.9
Medical writer job in Durham, NC
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.
$75k-100k yearly est. 60d+ ago
Grant and Budget Specialist
Nc State University 4.0
Medical writer job in Raleigh, NC
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
$29k-35k yearly est. 60d+ ago
Script Writer
Prescient Edge 3.8
Medical writer job in Jacksonville, NC
Prescient Edge is seeking a Script Writer to support a Federal government client. As a Script Writer, you will: * Have a clear understanding of the MARSOC organization, structure, and mission in order to perform script writing and coordination across all aspects of scenario development, and all other duties, responsibilities, and actions necessary to support SW/EP activities. The SW/EP shall perform all tasks associated with this position such as but not limited to:
* Develop a seamless training scenario with an operational theme that achieves all unit goals & objectives as defined.
* Ensure scenario and all supporting documents are IAW applicable documents and best practices; Supported by proposed training objectives, unit requested conditions, available resources, operational & Sub variables PMESII-PT, Joint/Conventional /SOF Doctrine, MARSOC Training and Readiness (T&R) Manual, Unit METL, SOPs.
* Provide a challenging and realistic exercise scenario and its conditions that incorporates red cell/white cell, checklists, master scenario event list (MSELs), injects, with timelines that allows personnel involved at every level an opportunity to demonstrate a clear understanding and all associated applicable skills IAW specified, essential, enhancing, and implied tasks to meet commanders' goals/objectives.
Benefits
At Prescient Edge, we believe that acting with integrity and serving our employees is the key to everyone's success. To that end, we provide employees with a best in class benefits package that includes:
* A competitive salary with performance bonus opportunities.
* Comprehensive healthcare benefits, including medical, vision, dental, and orthodontia coverage.
* A substantial retirement plan with no vesting schedule.
* Career development opportunities, including on-the-job training, tuition reimbursement, and networking.
* A positive work environment where employees are respected, supported, and engaged.
Job Requirements
Requirement
* Former Non-Commissioned Officer (NCO), Warrant Officer or Officer.
* Must have 10 years SOF experience from date of graduation from their perspective pipeline as an operator or leader in either a Special Mission Unit (SMU); U.S. Army Special Forces; Navy SEALs; Marine Special Operations Command; or U. S. Army 75th Infantry Ranger Regiment to include award and retention of their Military Occupational Specialty Qualification (MOS Q).
* Minimum of 5 SOF combat deployments of which 1 employing ASOT TTPs.
* Advance Special Operations Techniques Course (ASOTC) graduate.
* Minimum of 5 SOF combat deployments.
* Must have operated at the Battalion or higher staff level.
* Preferably had an assignment at a credited Exercise Control Branch such as NTC, JRTC or held a Team Leader or above position at an SMU as exercise planner on at least (1) multi-day JSOC RMT3 that has included RW infil/ exfils and explosive breaching and/ or MFF into an urban environment.
* Capable of data mining for unit's area of responsibility (AOR) specific current and relevant information as it pertains to script writing.
* Capable of structure training event(s) that establishes the conditions to facilitate performance-oriented training on properly selected, directed, and mission essential training objectives.
* Capable of developing specialized Courses of Instruction (COIs) for emerging mission requirement.
* Shall be required to travel up to 50% in the performance of assigned duties.
Prescient Edge is a Veteran-Owned Small Business (VOSB) founded as a counterintelligence (CI) and Human Intelligence (HUMINT) company in 2008. We are a global operations and solutions integrator delivering full-spectrum intelligence analysis support, training, security, and RD&E support solutions to the Department of Defense and throughout the intelligence community. Prescient Edge is an Equal Opportunity Employer (EEO). All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic that is protected by law. We strive to foster equity and inclusion throughout our organization because we believe that diversity of thought is critical for creating a safe and engaging work environment while also enabling the organization's success.
$55k-89k yearly est. 60d+ ago
Technical Writer
Zone It Solutions
Medical writer job in Jacksonville, NC
Job Description
Zone IT Solutions is seeking for a Technical Writer responsible for developing and maintaining enterprise-level technical documentation supporting data governance, data privacy, and cybersecurity initiatives.
Requirements
* 7+ years of experience in technical writing within regulated or enterprise environments
* Strong expertise in cybersecurity, data privacy, and data governance documentation
* Experience with compliance frameworks (NIST 800-53, SOX, ISO 27001, GDPR)
* Ability to translate complex technical and regulatory requirements into clear documentation
* Experience producing audit-ready policies, procedures, SOPs, and controls
* Proficiency with SharePoint, Confluence, and CMS tools
* Ability to create process flows, data flow diagrams, and visual documentation
* Strong collaboration skills with engineering, cybersecurity, risk, legal, and compliance teams
* Excellent written communication and attention to detail
* Bachelor's degree or equivalent relevant experience
Benefits
About Us
We specialize in Digital, ERP, and larger IT Services. We offer flexible, efficient and collaborative solutions to any organization that requires IT, experts. Our agile, agnostic, and flexible solutions will help you source the IT Expertise you need. If you are looking for new opportunities, send your profile at ******************************.
Also follow our LinkedIn page for new job opportunities and more.
Zone IT Solutions is an equal opportunity employer and our recruitment process focuses on essential skills and abilities. We encourage applications from a diverse array of backgrounds, including individuals of various ethnicities, cultures, and linguistic backgrounds, as well as those with disabilities.
$56k-79k yearly est. Easy Apply 14d ago
Editor-in-Chief (Physics, PhD)
Wiley Global Technology
Medical writer job in North Carolina
Our mission is to unlock human potential. We welcome you for who you are, the background you bring, and we embrace individuals who get excited about learning. Bring your experiences, your perspectives, and your passion; it's in our differences that we empower the way the world learns.
About the Role:
We are seeking a highly motivated and detail-oriented Editor-in-Chief with a PhD in Physics to join our in-house editorial team, particularly for our growing Open Access flagship journal Advanced Physics Research. This is an exciting opportunity to contribute to the strategic development and editorial direction of our leading
Advanced
family of journals. You will play a key role in ensuring the quality, integrity, and impact of published content, while working closely with authors, reviewers, and fellow editors.
How you will make an impact:
Leverage your network, subject expertise, and market awareness to drive content acquisition and submissions growth across the physics portfolio.
Strategically develop one or more journals from both scientific and publishing perspectives within the broader physics journals portfolio.
Establish and maintain a strong network of scientists who serve as authors, peer reviewers, and editorial board members.
Represent Wiley and the physics portfolio at conferences and through in-person and virtual outreach at universities and research institutes.
Contribute to editorial evaluation, peer review, and decision-making for manuscripts submitted to several journals.
Collaborate with your manager and colleagues to establish a team culture built on trust, respect, and high performance.
What we are looking for:
A PhD in Physics, with an excellent research background and strong understanding of current trends and developments in the field.
Strong teamwork and communication skills, with a flexible and innovative approach to problem-solving and a focus on achieving outcomes.
Ability to work collaboratively and achieve results through influence, relationship-building, and subject credibility.
A self-motivated, diplomatic, and adaptable approach, with outstanding organisational and time-management skills and excellent command of English (written and verbal).
A strong understanding of scientific publishing, including commissioning and the peer-review process. Prior publishing experience is highly desired.
A keen interest in science communication and a strong desire to advocate for innovations in publishing and open research.
Confidence in presenting and representing the journal portfolio at conferences and during institute visits, and willingness to travel.
About Wiley:
Wiley is a trusted leader in research and learning, our pioneering solutions and services are paving the way for knowledge seekers as they work to solve the world's most important challenges. We are advocates of advancement, empowering knowledge-seekers to transform today's biggest obstacles into tomorrow's brightest opportunities.
With over 200 years of experience in publishing, we continue to evolve knowledge seekers' steps into strides, illuminating their path forward to personal, educational, and professional success at every stage. Around the globe, we break down barriers for innovators, empowering them to advance discoveries in their fields, adapt their workforces, and shape minds.
Wiley is an equal opportunity/affirmative action employer. We evaluate all qualified applicants and treat all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, protected veteran status, genetic information, or based on any individual's status in any group or class protected by applicable federal, state or local laws. Wiley is also committed to providing reasonable accommodation to applicants and employees with disabilities. Applicants who require accommodation to participate in the job application process may contact ******************* for assistance.
We are proud that our workplace promotes continual learning and internal mobility. Our values support courageous teammates, needle movers, and learning champions all while striving to support the health and well-being of all employees. We offer meeting-free Friday afternoons allowing more time for heads down work and professional development, and through a robust body of employee programing we facilitate a wide range of opportunities to foster community, learn, and grow.
We are committed to fair, transparent pay, and we strive to provide competitive compensation in addition to a comprehensive benefits package. The range below represents Wiley's good faith and reasonable estimate of the base pay for this role at the time of posting roles either in the United Kingdom, Canada or USA. It is anticipated that most qualified candidates will fall within the range, however the ultimate salary offered for this role may be higher or lower and will be set based on a variety of non-discriminatory factors, including but not limited to, geographic location, skills, and competencies.
When applying, please attach your resume/CV to be considered.
Salary Range:
54,900 USD to 78,633 USD#LI-JG2
$36k-58k yearly est. Auto-Apply 54d ago
Reporting - (3MC) Megacenter
Omega World Travel 4.7
Medical writer job in Jacksonville, NC
Reporting Agent: Omega World Travel, one of the world's largest travel management companies in the U.S., is seeking an experienced Reporting Agent for our Jacksonville, NC office. Minimum 3 years business or general accounting experience preferred. Ability to work in a fast-paced, rapidly changing environment.
Primary Job Functions:
*High productivity expectations with required deadlines
*On-going daily data entry
*Credit Card Reconciliations
*Communicates effectively with all related parties
Requirements:
*Flexible with schedule
*Proficient in MS Excel
*Excellent written and verbal communication skills
*Outstanding customer service skills
*Demonstrated computer aptitude on a variety of Microsoft Office Products
*Demonstrated aptitude on Settlement/ARC Test
*Self-Starter, detail oriented and organized
*Ability to prioritize tasks to meet strict deadlines
$37k-58k yearly est. 9d ago
Environmental Grant Writer
David Joseph & Company 4.3
Medical writer job in Wilkesboro, NC
The Environmental Grant Writer identifies and pursues funding opportunities to support environmental programs, research initiatives, conservation efforts, and sustainability projects. This role develops compelling grant proposals, prepares supporting documents, and collaborates with internal teams to secure financial resources. The position requires strong writing skills and a solid understanding of environmental issues, data, and project design.
Primary Essential Functions:
Identify, research, and evaluate government, foundation, and corporate grant opportunities aligned with organizational needs.
Write, edit, and submit high-quality grant proposals, letters of inquiry, and concept notes tailored to funder guidelines.
Gather information and collaborate with program staff, scientists, and leadership to develop accurate and persuasive project narratives.
Prepare grant budgets and financial documentation in partnership with finance teams.
Track proposal deadlines, submission schedules, reporting requirements, and grant activity within internal databases.
Compile environmental data, impact metrics, and program outcomes to support proposal narratives and reporting.
Draft narrative and financial reports for awarded grants and communicate updates to funders as required.
Secondary Essential Functions:
Perform all other duties as assigned.
Work collaboratively and effectively with clients and colleagues, including cross-functional teams, peers, direct reports, and leadership, fostering a positive and inclusive work environment.
Adapt to changing business needs and priorities, demonstrating flexibility in taking on new responsibilities and adjusting to evolving challenges.
Competencies (Knowledge, Skills, Abilities):
Knowledge
Environmental issues such as conservation, climate change, habitat restoration, and sustainability.
Grant funding landscape, including government, foundation, and corporate sources.
Proposal development processes, grant compliance requirements, and post-award reporting.
Basic budgeting principles and environmental impact metrics.
Skills
Exceptional written communication, editing, and storytelling skills.
Strong research and analytical skills for identifying funding opportunities and synthesizing complex information.
Project management and time-management skills with the ability to meet multiple deadlines.
Proficiency with grant research databases, online submission portals, and document-tracking systems.
Collaboration and interpersonal communication skills for working with interdisciplinary teams.
Abilities
Translate complex scientific and technical information into clear, compelling narratives.
Prioritize tasks effectively and manage competing deadlines.
Build productive working relationships with staff, partners, and funders.
Maintain accuracy and attention to detail across multiple projects.
Job requirements
Qualifications:
Bachelor's degree in environmental science, Sustainability, Natural Resources, Communications, or a related field.
Experience writing successful grants, proposals, or technical reports.
Strong understanding of environmental topics relevant to the organization's mission.
Excellent writing, editing, research, and organizational skills.
Preferred
Master's degree in an environmental or related discipline.
3+ years of grant writing experience, particularly in environmental nonprofits or research-based organizations.
Familiarity with federal grant platforms such as Grants.gov, USDA, EPA, and NOAA.
Experience developing budgets, logic models, and impact measurement tools.
Physical Requirements:
Ability to remain seated for extended periods while working at a computer or attending meetings.
Frequent use of standard office equipment, including computers, keyboards, telephones, and printers.
Occasional light physical activity such as walking, standing, or carrying materials (up to 25lbs.).
Ability to communicate clearly and effectively in person, over the phone, and through written communication.
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$40k-55k yearly est. 9d ago
Environmental Grant Writer
Stratus Team
Medical writer job in Wilkesboro, NC
The Environmental Grant Writer identifies and pursues funding opportunities to support environmental programs, research initiatives, conservation efforts, and sustainability projects. This role develops compelling grant proposals, prepares supporting documents, and collaborates with internal teams to secure financial resources. The position requires strong writing skills and a solid understanding of environmental issues, data, and project design.
Primary Essential Functions:
Identify, research, and evaluate government, foundation, and corporate grant opportunities aligned with organizational needs.
Write, edit, and submit high-quality grant proposals, letters of inquiry, and concept notes tailored to funder guidelines.
Gather information and collaborate with program staff, scientists, and leadership to develop accurate and persuasive project narratives.
Prepare grant budgets and financial documentation in partnership with finance teams.
Track proposal deadlines, submission schedules, reporting requirements, and grant activity within internal databases.
Compile environmental data, impact metrics, and program outcomes to support proposal narratives and reporting.
Draft narrative and financial reports for awarded grants and communicate updates to funders as required.
Secondary Essential Functions:
Perform all other duties as assigned.
Work collaboratively and effectively with clients and colleagues, including cross-functional teams, peers, direct reports, and leadership, fostering a positive and inclusive work environment.
Adapt to changing business needs and priorities, demonstrating flexibility in taking on new responsibilities and adjusting to evolving challenges.
Competencies (Knowledge, Skills, Abilities):
Knowledge
Environmental issues such as conservation, climate change, habitat restoration, and sustainability.
Grant funding landscape, including government, foundation, and corporate sources.
Proposal development processes, grant compliance requirements, and post-award reporting.
Basic budgeting principles and environmental impact metrics.
Skills
Exceptional written communication, editing, and storytelling skills.
Strong research and analytical skills for identifying funding opportunities and synthesizing complex information.
Project management and time-management skills with the ability to meet multiple deadlines.
Proficiency with grant research databases, online submission portals, and document-tracking systems.
Collaboration and interpersonal communication skills for working with interdisciplinary teams.
Abilities
Translate complex scientific and technical information into clear, compelling narratives.
Prioritize tasks effectively and manage competing deadlines.
Build productive working relationships with staff, partners, and funders.
Maintain accuracy and attention to detail across multiple projects.
Qualifications:
Bachelor's degree in environmental science, Sustainability, Natural Resources, Communications, or a related field.
Experience writing successful grants, proposals, or technical reports.
Strong understanding of environmental topics relevant to the organization's mission.
Excellent writing, editing, research, and organizational skills.
Preferred
Master's degree in an environmental or related discipline.
3+ years of grant writing experience, particularly in environmental nonprofits or research-based organizations.
Familiarity with federal grant platforms such as Grants.gov, USDA, EPA, and NOAA.
Experience developing budgets, logic models, and impact measurement tools.
Physical Requirements:
Ability to remain seated for extended periods while working at a computer or attending meetings.
Frequent use of standard office equipment, including computers, keyboards, telephones, and printers.
Occasional light physical activity such as walking, standing, or carrying materials (up to 25lbs.).
Ability to communicate clearly and effectively in person, over the phone, and through written communication.
Equal Opportunity Statement
Stratus is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Stratus Team's management Team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.
#LI-JS1
$39k-57k yearly est. Auto-Apply 57d ago
Test Scripts Writer
Ask It Consulting
Medical writer job in Durham, NC
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.
$28 hourly 60d+ ago
Grant Management Specialist
Johnson C Smith University 3.7
Medical writer job in Charlotte, NC
Responsibilities GENERAL STATEMENT OF JOB The Grant Management Specialist is a key contributor to the success of the University's research and sponsored programs, overseeing the full lifecycle of grants, and contracts from identifying funding opportunities to post-award management and final closeout. Reporting to the Director of Government Sponsored Programs and Research this position provides high-level administrative and technical support to faculty and staff across disciplines, ensuring compliance and efficiency throughout the grant process. This is a grant-funded position that directly supports the University's mission to advance research, innovation, and academic excellence.
SPECIFIC DUTIES AND RESPONSIBILITIES
Essential Job Functions
* Serves as a liaison to faculty and professional staff to meet requirements to initiate and develop proposal concepts, and applying methods to progress to submission of applications to various federal, state and local agencies.
* Provide technical assistance to fund seekers in all aspects of grant award acquisition, to include renewal requests and collaborations.
* Assist with providing technical assistance with preparation for grant submissions by guiding constituents to assure supporting documents to substantiate quality proposals are efficiently remitted.
* Assists faculty and staff in identifying organizations for collaboration as co-investigators to develop grant proposals to secure extramural funding to support university efforts in instruction, research and service.
* Assist in facilitating training in specialized areas to faculty and staff as appropriate, to educate, interpret or explain institutional, governmental and funding agencies' policies, regulations and rules as they pertain to program compliance, grant administration and proposal development.
* Staying abreast of institutional, governmental and funding agencies' policies, regulations and rules particularly all applicable regulations statues pertaining to government funding requirements in the Uniform Guidance (2 CFR 200).
* Responsible for preparing and updating Grant Board Report
Pre-Award Responsibilities:
* Assist in the preparation and submission of grant proposals, ensuring compliance with institutional and sponsor requirements.
* Serves as a liaison to faculty and professional staff to meet requirements to initiate and develop proposal concepts, and applying methods to progress to submission of applications to various federal, state and local agencies.
* Collect and review required documentation such as budgets, budget justifications, bio sketches, and other proposal components.
* Enter and track proposal submissions in internal systems.
* Help interpret funding opportunity announcements and communicate key requirements to stakeholders.
* Assist with electronic submission systems (e.g., Grants.gov, ASAP, Fastlane, Research.gov).
Post-Award Responsibilities:
* Support the setup and maintenance of awarded grants in financial systems.
* Monitor budget expenditures to ensure allowability, allocability, and reasonableness according to sponsor and institutional guidelines.
* Assist in processing award modifications, no-cost extensions, and budget revisions.
* Prepare and review basic financial reports and help reconcile grant accounts.
* Serve as a liaison between PIs, departments, and sponsors on award management matters.
Closeout Responsibilities:
* Ensure timely submission of technical, financial, and administrative reports required for grant closeout.
* Verify that all expenses are appropriately recorded and that any cost transfers are completed.
* Work with relevant offices to confirm that all compliance obligations (e.g., invention disclosures, equipment reports) are met.
* Support the closeout of subawards and ensure final payments and documentation are submitted.
* Assist with audit requests and the retention of grant documentation per policy.
ADDITIONAL JOB FUNCTIONS
Performs other duties as required to meet organizational needs.
Qualifications
Bachelor's Degree preferred with 3-5 years' experience in grant administration working on projects funded by grants or contracts from the federal, state or local government in a public or private sector environment. Certified Research Administrator (CRA) preferred but not required.
Knowledge of policies and procedures regarding government (federal, state and local) grant and contract compliance and administration requirements, in particular, those in the Uniform Guidance (2 CFR 200) and Federal Acquisition Regulations (FAR).
Ability to implement training programs related to governmental research compliance.
Ability to manage multiple priorities and projects while working as part of a team.
Ability to keep abreast of the current regulatory environment governing the conduct of biomedical and behavioral research.
Ability to respond quickly to a variety of request and needs maintaining a balance of focus such as ensuring institutional compliance and providing service to faculty researchers and professional staff.
Computer literacy and experience with Microsoft Office Suite and Internet required.
Supplemental Information
To apply, please include a cover letter, resume, and contact information for three supervisory references including the most recent supervisor.
Finalists for this position are subject to a background check. Employment is contingent upon the successful completion of a background investigation including criminal history and identity check.
$29k-35k yearly est. 14d ago
Principal Medical Writer - Publications
Syneos Health, Inc.
Medical writer job in Morrisville, 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
* 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 medicalwriters 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.
$71k-105k yearly est. 13d ago
Senior Technical Writer
Contact Government Services, LLC
Medical writer job in Charlotte, NC
Job DescriptionSenior Technical WriterEmployment Type: Full-Time, ExperiencedDepartment: Technology Support CGS is seeking an experienced Senior Technical Writer to provide consultative, analytical, and documentation support for a large Federal agency initiative.
CGS brings motivated, highly skilled, and creative people together to solve the government's most dynamic problems with cutting-edge technology. To carry out our mission, we are seeking candidates who are excited to contribute to government innovation, appreciate collaboration, and can anticipate the needs of others. Here at CGS, we offer an environment in which our employees feel supported, and we encourage professional growth through various learning opportunities.
Skills and attributes for success:- Drafting and development of technical documentation related to a variety of projects in the IT space.- Work closely with project stakeholders to establish technical processes and procedures.- Document projects through the SDLC.- Provide status reports for multiple ongoing projects and related documentation efforts.- Assist with both user and admin level documentation.
Qualifications:- Excellent writing and Communication skills.- 5+ years experience with development of technical documentation.- 3+ years experience with development of user documentation.- Fluency with industry standard technical summary and reporting techniques including Agile project management methodology.- Ability to produce quality work independently or in a group setting.- Experience with MS Office Suite including Visio.- Willingness and ability to pass background check/security screening.
Ideally, you will also have:- Familiarity with Business Intelligence/Analysis applications.- Experience with Government software development policies and procedures.- Client facing communication experience.- Federal Agency issued security clearance.
Our Commitment:Contact Government Services (CGS) strives to simplify and enhance government bureaucracy through the optimization of human, technical, and financial resources. We combine cutting-edge technology with world-class personnel to deliver customized solutions that fit our client's specific needs. We are committed to solving the most challenging and dynamic problems.
For the past seven years, we've been growing our government-contracting portfolio, and along the way, we've created valuable partnerships by demonstrating a commitment to honesty, professionalism, and quality work.
Here at CGS we value honesty through hard work and self-awareness, professionalism in all we do, and to deliver the best quality to our consumers mending those relations for years to come.
We care about our employees. Therefore, we offer a comprehensive benefits package.- Health, Dental, and Vision- Life Insurance- 401k- Flexible Spending Account (Health, Dependent Care, and Commuter)- Paid Time Off and Observance of State/Federal Holidays
Contact Government Services, LLC is an Equal Opportunity Employer. Applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Join our team and become part of government innovation!
Explore additional job opportunities with CGS on our Job Board:**************************************** more information about CGS please visit: ************************** or contact: Email: *******************
#CJ
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
$61k-84k yearly est. Easy Apply 15d ago
Grant Specialist
Insight Global
Medical writer job in Greensboro, NC
Day-to-day: - Working closely with faculty, principal investigators, and project directors throughout the University and external agencies - Provide technical pre-and post-award support to principal investigators and project directors in the development, review and submission of all routine/complex grant and contract proposals by providing extensive information and guidance for use in the proposal submission process with a concentration on budgetary matters
- Develop and maintain a schedule of funding cycles, proposal submissions, and reporting deadlines
- Ensure that applicants are aware of and comply with applicable deadlines
- Review completed proposal applications and contracts for accuracy, completeness and compliance with the requirements of the University, the University System, and the prospective funding agency
- Work with federal, state, and private funding entities-Develop and provide training on the administrative and financial requirements of the various awards as needed, as well as perform other duties as assigned.
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Skills and Requirements
o Bachelor's Degree
o 1-3 years of experience in research administration, working in Higher Education, non-profit, or hospital settings with grants
o Experience in a customer service role
o Experience writing, reviewing, developing, editing, and creating budgets/budget narratives, as well as submitting proposals
o Ability to read and review budgets, perform flight calculations, verify numbers, and complete Excel calculations
o Proficiency in MS Office (Excel, Word, PDF, Teams) and familiarity with Banner, Cayuse, Streamlyne, Kuali, or InfoEd - CRA Certification
- Knowledge of federal, state, and university grant programs that support research, instruction, and public service across disciplines and their submission process
How much does a medical writer earn in Havelock, NC?
The average medical writer in Havelock, NC earns between $60,000 and $128,000 annually. This compares to the national average medical writer range of $63,000 to $137,000.