Medical Writer
4 weeks ago
Consultant, Global Regulatory Affairs, Medical Writer, Pharmaceutical
Our client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with a Medical Writer to support clinical & regulatory submission, and technical documentation. This position is based within the Global Regulatory Affairs department. This candidate will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation. He/she will manage processes intended to increase project efficiency, quality, and the timely achievement of deliverables and ensure the needs of business are met, particularly in the preparation of accurate, timely, and multidisciplinary documents submitted to regulatory agencies worldwide.
Duties / Expectations of Role
- Proactively manages writing activities across assigned projects as appropriate, ensuring adherence to the medical writing strategy and alignment with business needs.
- Contributes to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents.
- Authors deliverables with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to protocols, clinical study reports, Investigator’s Brochures [IBs], annual reports, HA briefing packages and response documents, submission summary modules, and integrated data summary reports).
- Adheres to medical writing practices/systems/tools to support clinical studies in order to meet company goals and objectives.
- Assures that standardized practices are implemented and maintained across all therapeutic areas.
- Engages with team members to ensure medical writing continues to deliver value to the business.
- Ensures medical writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations.
Mandatory Requirements
- Minimum of a BA/BS in Life Science; graduate degree preferred
- 4-7 years pharmaceutical/biotechnology experience related to clinical research
- 4+ years medical writing experience in Pharma, Biotech, and/or CRO;
- Medical device experience preferred
- Demonstrated expertise in writing/developing clinical documents in support of global regulatory submissions
- Ability to interpret and organize scientific and clinical data
- Medical writing experience in Pharma, Biotech, and/or CRO; medical device experience preferred
- Experience with ICH and electronic submission guidelines for regulatory reports.
- Excellent computer skills including MS Office (Word, Excel, PowerPoint, Outlook); experience with electronic document management systems and other content authoring technologies preferred
Term & Start
- Remote
- 12-month contract, open to 12+ month extension
- 2 Video Interviews - Start 2-3 weeks from an offer
- Full time, 40 hours/week
- Benefits included (Medical, Dental, Vision, 401k
- Pay Range (95-100hr) based on experience
-
Medical Writer
1 week ago
charlotte, United States GForce Life Sciences Full timeConsultant, Global Regulatory Affairs, Medical Writer, PharmaceuticalOur client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with a Medical Writer to support clinical & regulatory submission, and technical documentation. This position is based within the Global Regulatory Affairs department. This candidate will...
-
Medical Writer
4 weeks ago
Charlotte, United States GForce Life Sciences Full timeConsultant, Global Regulatory Affairs, Medical Writer, PharmaceuticalOur client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with a Medical Writer to support clinical & regulatory submission, and technical documentation. This position is based within the Global Regulatory Affairs department. This candidate will...
-
Senior Medical Writer
7 days ago
Charlotte, United States GForce Life Sciences Full timeJob DescriptionJob DescriptionConsultant, Global Regulatory Affairs, Medical Writer, PharmaceuticalOur client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with a Medical Writer to support clinical & regulatory submission, and technical documentation. This position is based within the Global Regulatory Affairs...
-
Technical Writer
6 days ago
Charlotte, North Carolina, United States ProSidian Consulting, LLC Full timeJob DescriptionProSidian Consulting, LLC is seeking a skilled Technical Writer to join our team. As a Technical Writer, you will be responsible for developing, writing, and editing material for reports, manuals, briefs, proposals, instruction books, and related environmental and scientific publications.Key Responsibilities:Develop and write high-quality...
-
Procedure Writer
1 week ago
Charlotte, North Carolina, United States AppleOne Full timeJob DescriptionWe are seeking a skilled Procedure Writer to join our team at AppleOne. As a key member of our team, you will play a crucial role in creating and updating essential desktop procedure materials.Key Responsibilities:Procedure Development: Develop detailed procedures for Microsoft products, ensuring clarity and accuracy.Collaboration: Work...
-
Oracle Repot Writer
2 months ago
Charlotte, North Carolina, United States Professional Diversity Network Full timeApex Systems, Inc.Job#: Job Description: Position: Oracle Report Writer (Technical)Pay Rate: $60-70/hourLocation: RemoteContract Length: EOY +++Top Requirements:Oracle HCM experienceHeavy SQLOTBIBIPPlussesHCM ExtractsDay to Day Responsibilities/project specifics: This team is spearheading an implementation of Oracle HCM. There is a need related to building...
-
Documentation Specialist
6 days ago
Charlotte, North Carolina, United States ProSidian Consulting, LLC Full timeJob DescriptionProSidian Consulting, LLC is seeking a skilled Technical Writer to join our team. As a Technical Writer, you will be responsible for developing, writing, and editing material for reports, manuals, briefs, proposals, instruction books, and related environmental and scientific publications.Key Responsibilities:Develop and write high-quality...
-
Technical Content Specialist
2 days ago
Charlotte, North Carolina, United States Genesis10 Full timeJob SummaryGenesis10 is seeking a skilled Technical Writer to join our team for a 6-month contract position with a financial services client located in the Charlotte, NC area. This role is 100% onsite.Key ResponsibilitiesConsult on complex initiatives with broad impact and large-scale planning for Technology Business Services Consulting.Review and analyze...
-
Grant Manager
8 hours ago
Charlotte, United States Colliers Engineering & Design Full timeOverview Colliers Engineering & Design is seeking a full-time Grant Manager who can assist in the technical and administrative direction and supervision of grant applications and grant-funded projects. This role requires constant communication with project supervisors and clients to ensure that grants-related tasks are completed in accordance with the...
-
Associate Director Biostatistics
1 month ago
Charlotte, United States Penfield Search Partners Ltd Full timeAssociate Director BiostatisticsRemoteContact: Susan Devine - sdevine@penfieldsearch.comOur client is a clinical-stage biotech company with an established track record and a strong pipeline in Gene Therapy/Rare Disease, looking for an experienced Biostatistician. This is a hands-on role that will utilize your extensive technical expertise and experience to...
-
Associate Attorney
2 weeks ago
Charlotte, United States Hedrick Gardner Full timeFor more than 65 years, Hedrick Gardner Kincheloe & Garofalo LLP has built a strong tradition of representing business and industry with our comprehensive litigation services. With offices in Charlotte, Raleigh, Wilmington, and Asheville, North Carolina; and Columbia, South Carolina, Hedrick Gardner is one of the largest litigation and dispute management...
-
Associate Attorney
1 week ago
charlotte, United States Hedrick Gardner Kincheloe & Garofalo LLP Full timeFor more than 65 years, Hedrick Gardner Kincheloe & Garofalo LLP has built a strong tradition of representing business and industry with our comprehensive litigation services. With offices in Charlotte, Raleigh, Wilmington, and Asheville, North Carolina; and Columbia, South Carolina, Hedrick Gardner is one of the largest litigation and dispute management...
-
Associate Attorney
3 weeks ago
Charlotte, United States Hedrick Gardner Kincheloe & Garofalo LLP Full timeFor more than 65 years, Hedrick Gardner Kincheloe & Garofalo LLP has built a strong tradition of representing business and industry with our comprehensive litigation services. With offices in Charlotte, Raleigh, Wilmington, and Asheville, North Carolina; and Columbia, South Carolina, Hedrick Gardner is one of the largest litigation and dispute management...
-
Associate Attorney
1 week ago
charlotte, United States Hedrick Gardner Kincheloe & Garofalo LLP Full timeFor more than 65 years, Hedrick Gardner Kincheloe & Garofalo LLP has built a strong tradition of representing business and industry with our comprehensive litigation services. With offices in Charlotte, Raleigh, Wilmington, and Asheville, North Carolina; and Columbia, South Carolina, Hedrick Gardner is one of the largest litigation and dispute management...
-
Associate Attorney
2 weeks ago
Charlotte, United States Hedrick Gardner Kincheloe & Garofalo LLP Full timeJob DescriptionJob DescriptionCompany DescriptionFor more than 65 years, Hedrick Gardner Kincheloe & Garofalo LLP has built a strong tradition of representing business and industry with our comprehensive litigation services. With offices in Charlotte, Raleigh, Wilmington, and Asheville, North Carolina; and Columbia, South Carolina, Hedrick Gardner is one of...
-
Senior HR Data Analyst
1 month ago
Charlotte, North Carolina, United States Truist Full timeThe position is described below. If you want to apply, click the Apply button at the top or bottom of this page. You'll be required to create an account or sign in to an existing one. Need Help? ) If you have a disability and need assistance with the application, you can request a reasonable accommodation. Send an email to Accessibility ( (see below)...