Medical Writer

Integrated Resources, Inc ( IRI ); New Jersey; Remote; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Medical Writing Operations Manager III to lead project management and quality control initiatives in the preparation of scientific and regulatory documents. This remote role offers the opportunity to work closely with R&D teams, ensuring compliance with US and international regulations while enhancing the quality of documentation. The ideal candidate will possess a strong background in medical writing, project management, and a solid understanding of the clinical development process. Join a dynamic team and contribute to the advancement of investigational and marketed drugs and biologics!

Qualifications

• 5+ years of experience in pharmaceutical/biotech regulatory document preparation.
• Strong understanding of clinical development processes and project management.

Responsibilities

• Provide editorial assistance for scientific and regulatory documents.
• Manage development and updates of medical writing SOPs and templates.

Skills

Medical Writing

Project Management

Technical Writing

Quality Control

Regulatory Knowledge

Document Management Systems

Microsoft Office

Education

Bachelor’s degree in life sciences or related field

Tools

VeevaVault

SharePoint

EndNote

Job description

Title: Medical Writing Operations Manager III

Duration: 2 years+

Location: Remote (Princeton, NJ)

Pay rate: $ 73.45/hr.

Job Description:

• The primary responsibilities of a Manager, Medical Writing Operations, include, but are not limited to, providing project management, editorial, and QC assistance with the preparation of scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics; leading or providing support to Medical Writing process improvement initiatives; managing the development and update of SOPs, templates, and other guidance documents.

Responsibilities:

• Provides editorial assistance, including editing and formatting in alignment with the Client R&D Authoring Style Guide, with the preparation of scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics
• Performs ad hoc QC requests on R&D documents while working in close partnership with members of R&D functions
• Manages the development and update of medical writing SOPs, templates, and other guidance documents.
• A solid understanding of the clinical development process and the principles, concepts, practices, and standards of pharmaceutical project management.
• Knowledge of and/or ability to quickly assimilate US, ICH, and international regulations, requirements, and guidance associated with scientific and clinical/regulatory document preparation and submissions.
• Knowledge of Common Technical Document content templates as well as content expectations for IND/NDA/MAA and other regulatory documentation.
• Technical writing experience: ability to self-edit and improve own and others’ work to ensure readability, accuracy, consistency, and aesthetic presentation of data and information.
• Quality control experience in the preparation, review, and finalization of regulatory submissions and supporting documents, including in support of an eCTD or other regulatory documents per ICH or other applicable standards.
• Working knowledge of current electronic document management systems (e.g., VeevaVault, SharePoint) and publishing systems.
• Excellent working knowledge of software programs in Windows environment with high proficiency in word processing, flow diagrams, and spreadsheets.
• Advanced computer skills in Microsoft Office software (including Word, Excel, and PowerPoint) and reference management software (e.g., EndNote).

Education:

• Bachelor’s degree, preferable in life sciences, professional/technical writing, or related field, with a minimum of 5 years of pharmaceutical/biotech experience in the regulatory document preparation/management arena required.