Raleigh, North Carolina, United States · Hybrid
For the past 25 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 …
Skills: Medical Writing, Clinical Research, Regulatory Submissions, Project Management, QC Review
Charlotte, North Carolina, United States · On-site
Leadership Track to Operations Manager Full-Time | Greater Charlotte Area At Touching Hearts at Home, we care for seniors and families during some of the most important and vulnerable moments of their lives. Every phone …
Skills: Caregiver Scheduling, Staffing Coordination, Healthcare Administration, Office Management, Operational Leadership
Haw River, North Carolina, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Production Supervision, Scheduling, Quality Assurance, Regulatory Compliance, Preventative Maintenance Coordination
Boston, Massachusetts, United States · On-site
$140k–$285k/yr
Job Description: Note: Fidelity will not provide immigration sponsorship for this position. The Role Fidelity is actively seeking an experienced architect to lead a team of data architects in the Asset Management Technol…
Skills: Data Architecture, Technical Leadership, SQL, Python, Scala
Research Triangle Park, North Carolina, United States · Remote OK
Senior Product Manager - Microsoft Azure This role is eligible for full-time remote employment within the US or can be hybrid in our Durham, NC office 2-3 days/week. Please note that we unfortunately cannot sponsor H1B v…
Skills: Product Management, Azure Ecosystem, B2B SaaS, Cloud Computing, Market Research
Raleigh, North Carolina, United States · On-site
Job Description Dewberry has one of the strongest electrical teams in the Raleigh area with over 30 electrical design professionals. You will be joining a team of highly skilled, experience, and dedicated electrical prof…
Skills: Electrical Design, Team Leadership, Project Management, Water/Wastewater Infrastructure, NEC Knowledge
Charlotte, North Carolina, United States · On-site
$96k–$116k/yr
Thank you for your interest in a career at Regions. At Regions, we believe associates deserve more than just a job. We believe in offering performance-driven individuals a place where they can build a career --- a place …
Skills: Credit underwriting, Financial modeling, Risk analysis, Portfolio management, Leveraged finance
Wilmington, North Carolina, United States · On-site
$58k–$85k/yr
Service Project Coordinator Department: 45Dives Technical Service Company: 45Drives Ltd. Location: Wilmington, North Carolina Work Arrangement: On-site, Full-Time Employment Type: Permanent Shift: Monday to Friday, 9:00 …
Skills: Project coordination, Technical documentation, Communication, Time management, Stakeholder management
Raleigh, North Carolina, United States · Remote OK
$140k–$180k/yr
Summary: National Power, LLC is actively seeking a Sales & Business Development Manager for our Data Centers Solutions division. Under the general direction of and reporting to the VP, Data Centers, you'll be primarily r…
Skills: Business Development, Sales Strategy, Power Generation Systems, Facilities Management, Renewable Energy Solutions
Asheville, North Carolina, United States · On-site
$32/hr–$36/hr
Veterinary Technician Assistant Supervisor & Training Coordinator - CVT/LVT/RVT | $30–$34/hr | Relocation Assistance Available Location: Asheville, NC Schedule: Full-Time | Flexible Schedule Based on Training Needs | 5 x…
Skills: Clinical Mentorship, Staff Training, Emergency and Critical Care, Onboarding, Coaching
Highlands, North Carolina, United States · On-site
Job DetailsJob Location: 137 S 4TH ST - Highlands, NC 28741Summary Front Desk Supervisor is responsible for overseeing all aspects of the front office operations. They are responsible for maintaining a high level of cust…
Skills: Front Office Management, Customer Service, Staff Coaching, Payroll Management, Problem Resolution
Raleigh, North Carolina, United States · On-site
$70k–$100k/yr
About Advyzon Advyzon was recently named to the "Best Places to Work in Fintech" list. Advyzon was founded in 2012 with the purpose of building an intuitive all-in-one technology for advisory firms. Based in Chicago, Ill…
Skills: Relationship Management, Client Retention, Portfolio Management, Wealth Management, Fintech
Edenton, North Carolina, United States · On-site
$16/hr–$23/hr
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate…
Skills: Supervision, Customer Service, Deductive Reasoning, Analytical Skills, Computer Skills
Greenville, North Carolina, United States · On-site
$35k–$45k/yr
Join Our Management Team! Full-Time & Part-Time Opportunities Available Are you the next rock star leader we’re looking for? CHC Unified, one of the largest and fastest-growing Jimmy John’s franchisees, owns and operates…
Skills: Restaurant operations, Customer service, Leadership, Team management, Organizational skills
Charlotte, North Carolina, United States · On-site
Where: Charlotte, NC 28273 Work Schedule: Monday-Friday, 10AM-6:30PM. NO WEEKENDS!! Type: Full Time, Non-Exempt Wage: starts at $18.50 Benefits: Medical, Dental, Vision, 401K, Paid-Time Off, Sick Time, Tuition Reimbursem…
Skills: Inventory Control, Material Handling Equipment, Cycle Counting, Staff Training, Warehouse Management
Durham, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: Perioperative Supply Chain Management, Inventory Optimization, Matrix Leadership, Cost Containment, Vendor Management
Durham, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: Sterile Compounding, Quality Assurance, USP <797> Compliance, Environmental Monitoring, Staff Training
Greenville, North Carolina, United States · On-site
Job Description Time to step up your career! This is your moment to shine and lead the way for others too. We’re hiring full-time Food Service Supervisors to join our passionate Food Services Team. Alongside a manager wh…
Skills: Staff Supervision, Food Safety, Inventory Management, Scheduling, Team Leadership
Jackson County, North Carolina, United States · On-site
Job Description Time to step up your career! This is your moment to shine and lead the way for others too. We’re hiring full-time Food Service Supervisors to join our passionate Food Services Team. Alongside a manager wh…
Skills: Staff Supervision, Food Production, Inventory Management, Scheduling, Food Safety
Winston-Salem, North Carolina, United States · On-site
Job Description Time to step up your career! This is your moment to shine and lead the way for others too. We’re hiring full-time Food Service Supervisors to join our passionate Food Services Team. Alongside a manager wh…
Skills: Staff Supervision, Inventory Management, Food Safety, Scheduling, Employee Training
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The Principal Medical Writer is responsible for authoring and managing complex clinical and regulatory documents such as protocols, IBs, and NDAs. They lead cross-functional coordination, mentor junior writers, and manage client expectations to ensure high-quality deliverables are met on time.
Candidates must have a bachelor's degree or higher in a scientific discipline and at least 7 years of experience writing clinical or regulatory documents. Proficiency in FDA regulations, ICH guidelines, and expert-level MS Word skills are required.
For the past 25 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.
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 required.
Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).
Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.
Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.
Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.
Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team.
Participates in and leads departmental initiatives (e.g., process improvement, lunch and learns, etc.).
Other duties as assigned.
Necessary Skills and Abilities:
Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information.
Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.
Advanced understanding of regulatory submission requirements and processes.
Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.
Exceptional project management skills and strong communication skills with a high attention to detail and quality.
English language proficiency and familiarity with American Medical Association (AMA) style.
Strong experience in relationship building and strategic collaboration on key business accounts.
Thinks proactively, takes initiative, and willingly takes on new challenges.
Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.
Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed.
Works effectively in a collaborative team environment.
Demonstrates a growth mindset and positive outlook in all work activities.
Educational Requirements:
Bachelor’s degree or higher, preferably in medical or scientific discipline.
Experience Requirements:
Minimum of 7 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.
Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a casebycase basis.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
End-to-end bespoke solutions that de-risk & accelerate our partners' and sponsors' drug and device development programs
At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market. From early development through clinical, regulatory approval, and commercialization, we provide expert guidance to navigate complex challenges and accelerate success. Our mission is simple: improving patient health and safety by delivering the highest-quality regulatory, compliance, clinical research, pharmacovigilance, and medical information services throughout the entire product lifecycle. With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risks and accelerates high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science!
Offices: 107 W Hargett St, Raleigh, North Carolina 27601, US · Olliver, Richmond, North Yorkshire DL10 5HX, GB · Schipholweg 59, P.O. Box 255, Leiden, AG 2316 ZL, NL · Siemensdamm 62, Berlin, Germany 13627, DE · Solnavägen 3H, 113 63 Stockholm, Sweden, Stockholm, Stockholm County SE -112, SE
Based on 4269 listings with disclosed salaries, most management & leadership jobs in North Carolina pay between $65k–$180k per year. Individual offers vary with seniority, company size, and specialization.
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Companies currently hiring include Domino's, CVS Health, Dollar Tree Stores, Duke Health Technology Solutions, American Addiction Centers, among others. Browse the listings above to see every active employer.
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