Pharm-Olam, LLC

Medical Writer

Job Locations US-NC-Raleigh-Durham | US
Job ID
2021-2816
Category
Biostatistics

Overview

About Pharm-Olam, LLC:

 

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

 

Summary

 

Under departmental supervision, researches, creates, edits, and coordinates the production of clinical documents such as study protocols and consent forms, clinical study reports and Investigators brochures. May provide writing support for more complex clinical documentation such as IMPDs, DSUR, etc.  Works within a project team with project managers, data managers, statisticians, regulatory officers, medical officers to ensure the timely and efficient delivery of study documents. For stand-alone projects, may serve as primary technical contact with client under appropriate department supervision.

Responsibilities

  • Writes clinical documents associated with submissions to regulatory authorities including but not limited to investigator brochures, study protocols, model informed consents, interim and final clinical study reports, as required by client contracts.
  • Prepares clinical documents that are not necessarily part of regulatory submissions, including but not limited to study manuals, monitoring guidelines, and manuscripts.
  • Serves as the Medical Writing representative on assigned project teams, providing proactive support to Project Management for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other department deliverables. Identifies any potential project challenges to departmental line management and project manager including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
  • Participates actively on project teams that have a medical writing component including the preparation of a Medical Writing Plan for the Project Plan with timelines and details as appropriate to the contract.
  • Reviews statistical analysis plans to assist in determining appropriateness of content/format for clinical writing.
  • Provides medical editing review of draft and final documents prepared by other writers before internal/external distribution. This includes both copy editing and content review.
  • Ensures document content and style adheres to EMEA/FDA or other appropriate regulatory guidelines, and complies with departmental and client SOPs and style guidelines.
  • Oversees and ensures that all protocols, investigator’s brochures and clinical trial reports written by Pharm-Olam have appropriate scientific input and research and are reviewed and approved in accordance with Pharm-Olam’s SOPs.
  • Assists where appropriate the Project Manager in discussions with clients on Study documentation issues or technical related documentation concerns that may have arisen.
  • Performs literature searches/reviews as necessary to obtain background information and training for development of documents.
  • Other responsibilites as required.

Working Relationships

  • Report to the Medical Writing Manager
  • Collaborate and liaise with the representatives of Clinical Project Management as needed
  • Collaborate and liaise with the other members of Medical Department
  • Collaborate and liaise with the representatives of Global Data Division and Regulatory Department as needed
  • Collaborate and liaise with the representatives of Business Development, Quality Assurance Department and the Department Heads as needed

Qualifications

  • A first degree or higher education (PhD/MD) in a relevant science
  • At least 2 years experience in regulatory writing and knowledge of preparing documents to ICH standards
  • Knowledge in a variety of therapeutic areas
  • Proven organisational abilities, and excellent written and oral communication skills
  • Must be fluent in written and spoken English
  • Computer literacy (PowerPoint/Word; Adobe Acrobat, etc.).

 

For Consideration

 

Please apply online at www.pharm-olam.com/careers

 

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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