Technical Writer
Medical writer job in Monroe, NC
Our Client is seeking a Technical Writer to join their growing team!
The ideal candidate will be responsible for creating and writing various types of user documentation, including how-to guides, manuals, references, or instructions. This candidate should have strong communication skills which enable them to explain complicated concepts in a simple manner.
Position Title: Technical Writer
Location: Monroe, NC Fully onsite
Interview Process: 2 rounds
Length: Contract | 6+ Months
Note : Defense experience very much preferred.
Ideal Candidate:
Develop comprehensive documentation that meets organizational standards.
Gain deep understanding of products and services, and translate complex information into simple, polished, engaging content.
Write user-friendly content that meets the needs of target audience, turning insights into language for user success.
Responsibilities
Research, outline, write, and edit content, working closely with various departments to understand project requirements.
Gather information from subject-matter experts and develop, organize, and write procedure manuals, technical specifications, and process documentation.
Research, create, and maintain information templates that adhere to organizational standards.
Develop content in alternative media forms for maximum usability.
Knowledge Skills & Abilities
Proven ability to quickly learn and understand complex subject matter.
Experience in writing documentation and procedure manuals for various audiences.
Superb written communication skills, with a keen eye for detail.
Experience in working with engineers and operations to improve user experience, refine content, and create visuals and diagrams for technical support content.
Ability to handle multiple projects simultaneously. Education & Experience
Bachelor's degree or equivalent work experience.
Demonstrated efficiency in Microsoft Office applications and Adobe Acrobat professional.
Principal Medical Writer - Regulatory Submission Documents
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
* 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
Principal Medical Writer
Medical writer job in Raleigh, NC
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
Contract Principal Medical Writer
Medical writer job in Raleigh, NC
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.***
Auto-ApplyPrincipal Medical Writer
Medical writer job in Raleigh, NC
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
Auto-ApplyPrincipal Medical Writer- FSP
Medical writer job in Columbia, SC
**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.
Senior/Principal Medical Writer - USA
Medical writer job in Durham, NC
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.
Research and Grant Award Specialist
Medical writer job in Orangeburg, SC
Job Details Claflin University Main Campus - Orangeburg, SC Full Time 4 Year Degree $50000.00 - $55000.00 Salary Up to 25% Day EducationDescription
Under the general direction of the Associate Vice Provost of Research, the Research and Grant Award Specialist will provide technical assistance in grant and research development and other aspects of research administration. Coordinate research efforts to identify and analyze funding resources from various federal, state, and local agencies to match faculty and professional staff's research background and interests. Review and submit grant applications on behalf of the University to sponsors. Provide training and support in grant and research development. Interprets and explains institutional, governmental, and funding agencies' policies, regulations, and rules to faculty and staff as appropriate. In addition, assists in reviewing and monitoring the compliance of grant and contract applications with institutional, governmental, and funding agencies' policies, regulations, and rules, particularly all applicable regulation statutes of government funding requirements in the Uniform Guidance (2 CFR 200). Assists the Associate Vice Provost of Research in developing and submitting regulatory documents, manage grant administration, monitor grant-funded project activities, responsible conduct of research, and ensure compliance with the laws, regulations, rules, and policies. Perform duties as assigned by the supervisor.
Qualifications
A Master's degree is required with 3-5 years of 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) is 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). Proficient in research methods. Ability to implement training programs related to governmental research compliance, grant development, and research development. Ability to keep abreast of the current regulatory environment governing the conduct of biomedical and behavioral research. Ability to respond quickly to various requests and needs, maintaining a balance of focus such as ensuring institutional compliance and providing service to faculty researchers and professional staff.
Senior Proposal Writer
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.
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.
Auto-ApplySenior Technical Writer
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
Auto-ApplySenior Technical Writer
Medical writer job in Parkton, NC
We have an exciting opportunity for a Senior Technical Writer. This is a hybrid opportunity based in our Evanston, IL OR Durham, NC office.
The Senior Technical Writer will support the development, maintenance and publication of safety standards, to advance the mission of UL Standards & Engagement (ULSE) to make the world safer, more secure, and sustainable. The Senior Technical Writer will develop and optimize technical standards documents across various industries and technologies. Support consensus-based standards process, leveraging expertise to synthesize complex information into precise, accessible language driving industry adoption and compliance.
UL Standards & Engagement:
At UL Standards & Engagement (ULSE), we expand the boundaries of safety science to create a more secure and sustainable world. For more than a century, we have created new safety standards and shared our findings with academia, scientists, manufacturers, and policymakers across industries. We identify critical safety and sustainability issues, asking tough questions because we believe a safer world begins with knowledge.
Build a safer, more secure, and sustainable future with us. Join us and work with our Standards teams who develop the standards required to put that knowledge into practice.
What you'll learn and achieve:
As the Senior Technical Writer, you will play a key role in the rapid growth of UL as you:
Manage end to end documentation projects, drive content development lifecycle from initial draft through proposal. Collaborate with internal teams, subject matter experts, and external stakeholders to produce clear, accurate content that reflects identified technical specifications.
Author, edit, and refine standards documents, technical reports and related publications ensuring adherence to format and style guidelines. Translate complex technical information into user-friendly content that meets the needs of diverse audiences.
Gain deep understanding of products and services, efficiently collating and interpreting complex information. Identify and gather relevant data from products, standards, test methods and related documents to prepare accurate and comprehensive technical reports.
Prepare and select illustrative materials, including drawings, diagrams and schematics to effectively present and communicate complex technical information in publications.
Drive collaboration within the team to ensure team-level goal achievement and enable success in effective execution of standards activities.
Support and facilitate internal and external meetings. Prepare meeting agendas, presentations, and other deliverables.
Build and maintain relationships with stakeholders, actively engage external stakeholders, and represent the organization through presentations, trade show and conference attendance, technical committees, and panel discussions.
Maintain version control and track changes for ongoing revisions of standards and technical publications. Format and prepare final documents for publication in digital and print format, ensure technical accuracy and conduct quality assurance before publication.
Ensure alignment with international standards development guidelines, including ISO, ANSI, IEC, regulatory requirements, and industry best practices.
Contribute to the continuous improvement of editorial workflows, templates, and document management processes. Identify opportunities to enhance document usability, readability, and accessibility for diverse audiences.
Maintain continued awareness of industry trends and external context related to the portfolio. Stay current with regulatory requirements and compliance frameworks governing public safety.
Perform other duties as directed.
What you'll experience working at UL Standards & Engagement: We have pursued our mission of working for a safer, more secure, and sustainable world for nearly 130 years, embedding conscientious stewardship into everything we do.
People: Our people make us special. You'll work with a diverse team of experts respected for their independence and transparency and build a network, because our approach is collaborative. We collaborate across disciplines, organizations, and geographies to build the global scientific response that today's global challenges require.
Interesting work: Every day is different for us here. We see what's on the horizon and use our expertise to build the foundations of a safer future. You'll have the opportunity to push the boundaries of human understanding as part of a team working to advance the public good.
Grow and achieve: We learn, work, and grow together through targeted development, reward, and recognition programs.
Values. Four core values guide our work: collaboration, respect, integrity, and beneficence. By living our values, we inspire the trust essential to fulfilling our mission and foster the partnerships that enable us to pursue a beneficent future in which we all can thrive.
Total Rewards: All employees at UL Standards & Engagement are eligible for bonus compensation. We offer comprehensive medical, dental, vision, and life insurance plans and a generous 401k matching structure of up to 5% of eligible pay. Moreover, we invest an additional 4% into your retirement saving fund after your first year of continuous employment. Depending on your role, you may be able to discuss flexible working arrangements with your manager. We also provide employees with paid time off, including vacation, holiday, sick, and volunteer days.
What makes you a great fit:
While no one candidate will embody every quality, the successful candidate will bring many of the following professional competencies and personal attributes:
Advanced proficiency in technical writing, document structuring and editing techniques, with ability to translate complex technical concepts into clear, concise, and accessible documentation for diverse audiences. Knowledge of regulatory frameworks, and technical terminology ensuring accuracy, consistency and compliance across all content.
Familiarity with structured authoring, XML, content management systems, and digital publishing tools.
Strong project management skills with experience developing comprehensive project plans, identifying and mitigating risks, and managing project resources to deliver successful outcomes.
Demonstrated leadership skills with ability to lead project teams and effectively communicate project goals, requirements and progress to various stakeholder groups.
Advanced problem-solving skills and experience analyzing and addressing issues with expertise in developing and implementing contingency plans.
Strong communication, presentation and facilitation skills, with ability to communicate key concepts and information to both technical and non-technical audiences.
Positive and collaborative interpersonal skills, with proven capability in fostering collaboration and partnership across teams to develop solutions with broad impact.
Strategic thinker with ability to innovate and adapt in a dynamic industry landscape.
Professional education and experience requirements for the role include:
Bachelor's degree. Advanced degree preferred.
Minimum 5 years related work experience.
Certification in technical writing strongly preferred.
Experience in standards development, accreditation or regulation strongly preferred.
About UL Research Institutes and UL Standards & Engagement
UL Research Institutes and UL Standards & Engagement are nonprofit organizations dedicated to advancing safety science research through the discovery and application of scientific knowledge. We conduct rigorous independent research and analyze safety data, convene experts worldwide to address risks, share knowledge through safety education and public outreach initiatives, and develop standards to guide safe commercialization of evolving technologies. We foster communities of safety, from grassroots initiatives for neighborhoods to summits of world leaders. Our organization employs collaborative and scientific approaches with partners and stakeholders to drive innovation and progress toward improving safety, security, and sustainability, ultimately enhancing societal well-being.
Our affiliate, UL Solutions, stands alongside us in working for a safer and more sustainable world. UL Solutions conducts testing, verification and certification, and provides training and advisory services, along with data-driven reporting and decision-making tools, for customers around the world.
To learn more, visit our websites UL.org and ULSE.org.
Salary Range:
$74,051.25-$101,820.46
Pay type:
Salary
Auto-ApplyProposal Writer
Medical writer job in Charlotte, NC
A multi-disciplinary architectural, engineering and construction firm is seeking a Proposal Writer, to help them create compelling proposals and estimates for clients at their Charlotte, NC office.
Your Day Includes
Developing and coordinating proposals and estimates
Participating in team meetings to review proposal progress
Assessing proposal requirements and identifying appropriate team leaders
Developing technical proposals based on templates and corresponding estimates
Contacting clients/prospects to obtain additional information and confirm proposal receipt
Must Haves
Exceptional analytical and written communication skills
Ability to handle quick deadlines and multiple proposals
Proficient in Microsoft Office Suite and familiar with Adobe Creative Suite
P.S.
In addition to offering a comprehensive health, dental, and vision package, the firm also provides a Costco Card and Gym Membership.
If you have the necessary qualifications and are excited about this opportunity, we encourage you to apply. We look forward to hearing from you.
Textbook Writer: Elementary Science
Medical writer job in Greenville, SC
ROLE SUMMARY: As a Writer at BJU Press, you will have the opportunity to influence students and educators around the world. This role combines your passion for teaching, formal training, classroom experience, and research expertise to develop innovative textbooks and teacher support materials. You will collaborate with a multidisciplinary team-including other writers, instructional design specialists, biblical worldview experts, educational technology professionals, editors, permissions coordinators, artists, and designers-to create academically rigorous content that integrates a biblical worldview, leverages technology, and fosters 21st century skills. Please note that this is not a remote position.
KEY RESPONSIBILITIES:
* Provide subject matter and pedagogical expertise.
* Conduct research and planning related to content, national and state standards, pedagogy, assessments, and teaching strategies.
* Work on a team to develop scope and sequence, objectives, and content for course revisions.
* Collaborate with writers and practitioners from other departments in the development of content.
* Plan and write student and teacher materials including student texts, teacher texts, student activities, assessments, and other appropriate ancillary pieces.
* Work with designers to combine content with visual elements in a storyboarding process.
* Coordinate with permissions specialists to ensure compliance with copyright laws.
* Proofread manuscripts to ensure all needed revisions are complete and that the content is correct.
SKILLS AND ATTRIBUTES NEEDED TO SUCCEED IN THIS ROLE:
* Writing skills that meet requirements for originality, clarity, academic integrity, and engagement.
* Ability to follow written and verbal instructions.
* Ability to meet deadlines.
* Acceptable content knowledge in the appropriate area.
* Ability to collaborate well with the other writer(s) on the team as well as with the practitioners from other departments.
* An understanding of the BJU Press Pillars and the ability to work together with specialists to incorporate them into the written product.
* Ability to accept and benefit from constructive criticism.
* Ability to adapt to changing processes or requirements.
REQUIRED QUALIFICATIONS:
* Education or subject-related degree with at least 3 years of relevant teaching experience.
* Advanced degree preferred.
ABOUT BJU PRESS
Vision: We want Christian education to be transformational in the lives of students as they grow in their faith and knowledge of our Savior, Jesus Christ.
Mission: We produce transformational products and services for Christian educators.
Brand Promise: We empower educators to prepare students to live in light of eternity.
About the Team: The writer team seeks to support the mission of BJU Press by researching and producing written manuscripts for instructional products that will be used by students and Christian educators from pre-school to grade 12. Writers produce materials that are written from and teach a clear biblical worldview, are academically rigorous and pedagogically sound, that develop critical thinking skills as well as a lifelong love of learning. Materials produced by writers incorporate robust educational technology resources and provide training in 21st century skills.
An applicant for a position in the Bob Jones University group - Bob Jones University, Bob Jones Academy or BJU Press - must be a born-again Christian who has a personal relationship with Jesus Christ. Each applicant must agree with and affirm the Bob Jones University creed, mission (see ******************************************** and core biblical doctrines regarding areas such as the Bible, the triune God, man and salvation, etc. Employees are expected to maintain a conservative lifestyle and support the group's positions on issues such as beverage alcohol and addictive substances, creation, marriage and human sexuality and the sanctity of life, etc., (***************************************** Employees are to be active members of a local Bible-believing church which holds orthodox theology. Whether in the classroom, online, through student activities, or through the preparation of educational materials for Christian schools and homeschool families, applicants must be committed to providing students an excellent, world-class education from a biblical worldview that prepares them for a lifetime of service for Jesus Christ.
#LI-Onsite
Required Education: Bachelors
Grants Management Specialist
Medical writer job in Columbia, SC
The position is located in the Research & Development (R&D) Service at the Columbia VA Healthcare Center (CVAHCS) in Columbia, SC. The R&D Service at this VA Medical Center (VAMC) is under the direction of the Administrative Officer (AO) for R&D. The position also performs routine budget administration functions in the formulation, execution, and review of the budget for the Service.
This is a non-bargaining unit position.
VA offers a comprehensive total rewards package: VA Total Rewards
Work Schedule: Full-time; Monday-Friday, 8:00am - 4:30pm
Compressed/Flexible: Not Available
Position Description/PD#: Grants Management Specialist/PD646250
Relocation/Recruitment Incentives: Not Authorized.
Permanent Change of Station (PCS): Not Authorized
Financial Disclosure Report: Not Required
Physical Demands: Work involves extensive computer use over long periods of time. The position will also be required to physically visit research laboratories within the building, requiring extensive walking. Extensive walking is also required between the Research Administrative Office and the CVAHCS and various areas of the affiliated university. The work is semi-sedentary and requires no special physical activities but requires the occasional lifting of boxes weighing 10-25 pounds.
Major Duties:
* Manage pre-award and post-award duties: preparation, review, and submission of research proposals to VA Central Office.
* Disseminate, track, and meet stringent deadlines to VA Central Office.
* Work as a liaison between the Research program, affiliated university departments and non-profit foundations.
* Responsible for preparing and approving Merit Award Applications and customizing each Request for Review Merit Award applications for VA Investigators. On average, the incumbent will oversee and manage the submission for VA grant applications for every 3-month cycle.
* Manage the collection and analysis of grant submission metrics to enhance the CVAHCS research program as well as manage VA funded research studies at any given time to ensure research compliance.
MO-7/17 - 7513 - Technical Writer w/ Medicaid Exp - Columbia, SC (Local to SC Candidates Only)
Medical writer job in Columbia, SC
** Candidate will work a Hybrid (4 days in office in Columbia, SC, 1 day remote). Candidate must be a CURRENT South Carolina resident. **
Our direct client has an opening for a Technical Writer w/ Medicaid Exp # 7513. This position is for 12+ months, with option of extension, and will be worked in a hybrid schedule - 4 days each week on-site in Columbia, SC.
If you are interested, please submit the following:
YOUR CURRENT RESUME
YOUR HOURLY RATE W2 Only Position - No Corp to Corp Allowed
Below is the - Resumes due ASAP -
Job Description:
The client is seeking a Technical Writer, Business Analyst, or Contract Writer with experience in developing and updating Advanced Planning Documents (APD) and maintaining documentation relating to State and/or Federal reporting, policies/procedures, and/or IT system requirements. This role will be part of the DASH Program that is responsible for managing the MES Modernization projects.
The primary responsibility of the Technical Writer is to work with the Business Leads, Project Teams, functional/matrix managers, vendors, contracting, budget offices, and other stakeholders to maintain Advanced Planning Documents (APDs) required by Centers of Medicaid/Medicare Services (CMS). This documentation involves drafting the business and technology narratives required to articulate the status of activities for all projects in various phases throughout the planning, implementation, and operations phases of their lifecycle and are directly related to CMS outcomes, state specific goals, and project requirements. The role must be able to take complex concepts and convert them into easily understood written documentation.
The Technical Writer will have a combination of project management, communications, business analysis and technical writing skills. They will assist with the assessment and analysis of project activities forecasted, completed and reported within APD. This role assists with producing the Advance Planning Documents and ties together all associated areas including business and technical architecture, project management, product management, finance, and contracting, to produce and report on IT project compliance.
General Duties and Responsibilities:
• Develop and maintain Advanced Planning Documents, and Technology-related documentation for federal financial proposals (similar to grants) and planning documents within required timelines
• Coordinate and meet with various teams, vendors, and stakeholders to support the gathering, analysis, and finalization of information
• Work closely with the business team, project teams, and subject matter experts to gain an understanding of project and related requirements to develop appropriate document content.
• Organize material and complete writing assignments according to agency standards regarding order, clarity, conciseness, style, and terminology
• Compile information, conduct research and assemble all applicable data necessary to develop solid, viable, meaningful APD
• Interface with project teams and technical support personnel to clearly articulate current state activities and translate the information provided into concise updates
• Collect documentation content from business and technical staff
• Develop an understanding of the business functions and systems in support of articulating the objectives within the associated documentation and alignment with federal guidelines
• Independently review and prepare documents for review and approval
• Review all relevant regulations and standards for APDs and other documentation are in alignment and serves as the expert on the subject
• Utilize tools, templates, and developed methods to keep abreast of project activities across the program
• Organize material and complete writing assignments according to agency standards regarding order, clarity, conciseness, style, and terminology
Required Skills:
3+ years of experience developing and maintaining Advanced Planning Documents (APD)
3+ years of experience working in Medicaid, Health IT, Health Insurance environment, public sector experience with health and human services programs
4+ years of experience with preparing technical documentation
3+ years working knowledge of government regulations as they pertain to the grant proposal and advance planning document writing process
Desired Skills:
Experience with the creation of Requests for Proposal (RFP), Requests for Information (RFI), or contracts
Experience documenting business process flows and related JAD, and RFP development/review actions
Prior knowledge of Budgeting, and/or Accounting
Experience with SharePoint, Microsoft Suite, Jira, or Confluence
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Proposal Writer - Heavy Civil Construction
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.
Auto-ApplyGrant and Budget Specialist
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
Grant Specialist
Medical writer job in Raleigh, NC
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.
Environmental Grant Writer
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.
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Auto-ApplyGrant Management Specialist
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.