Medical Writer Operations Manager

Compass Consulting; United States; On-site; USD 60,000 - 80,000; Full time

Job summary

An innovative firm in the pharmaceutical sector is seeking a skilled Medical Writer to manage and support the preparation of critical scientific and regulatory documents. This pivotal role involves collaborating across R&D functions to ensure compliance with industry standards while enhancing document quality. The ideal candidate will possess a strong background in technical writing and project management, with a keen understanding of regulatory requirements. Join a dynamic team where your expertise will contribute to groundbreaking therapies that improve patient outcomes. This position offers a competitive hourly rate and the opportunity to work in a fast-paced, collaborative environment.

Qualifications

• Minimum 5 years of experience in pharmaceutical/biotech regulatory document preparation.
• Strong understanding of clinical development processes and regulatory standards.

Responsibilities

• Manage and support projects in accordance with established processes and timelines.
• Provide editorial and project management support for scientific and regulatory documents.

Skills

Project Management

Technical Writing

Quality Control

Regulatory Document Preparation

Interpersonal Communication

Time Management

Education

Bachelor’s Degree in Life Sciences

Tools

VeevaVault

SharePoint

Microsoft Office Suite

EndNote

Job description

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Base pay range

$65.00/hr - $75.00/hr

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Scope:

Manages and supports projects in accordance with established processes and SOPs, meets timelines, and resolves challenges; effectively communicates and collaborates across R&D functions.

Position Summary:

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.

Primary Duties & Responsibilities:

• Provides editorial assistance, including editing and formatting in alignment with 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
• Provides project management support to medical writers with the preparation of scientific and regulatory documents, including the tracking and compilation of appendices for clinical study reports.
• Performs ad hoc QC requests on R&D documents while working in close partnership with members of R&D functions
• Leads or provides support to Medical Writing process improvement initiatives in collaboration with other medical writers and relevant cross functional R&D groups
• 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.
• Experience with authoring style guides, including providing input on making changes and improvements; familiarity with formal styles such as AMA preferred.
• 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 interpersonal, organizational, written and verbal communication skills.
• Project management experience: ability to support multiple projects simultaneously, be well organized, and have strong time management skills and attention to detail.
• 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).

Qualifications:

• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Writing/Editing, Quality Assurance, and Science

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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