Medical Writer

Net2Source Inc.; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company is seeking a Medical Writer to manage and support projects related to the clinical development of investigational drugs. The role requires strong project management and technical writing skills, along with a solid understanding of regulatory requirements. This position is fully remote and offers a competitive pay rate. Join a dynamic team focused on improving medical writing processes and ensuring high-quality documentation.

Qualifications

• Minimum 5 years in pharmaceutical/biotech regulatory document preparation.
• Experience with authoring style guides and regulatory submissions.

Responsibilities

• Manage and support projects in medical writing operations.
• Provide editorial assistance for scientific and regulatory documents.
• Lead process improvement initiatives in medical writing.

Skills

Project Management

Technical Writing

Quality Control

Communication

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

VeevaVault

SharePoint

Job description

This range is provided by Net2Source Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$65.00/hr - $73.00/hr

Direct message the job poster from Net2Source Inc.

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

Job Description:

Job Title: Medical Writer

Location: 100% Remote

Duration: 24+ Months (Extendable)

Pay Rate: $65.00 - 73.95/hr on W2

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 the 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.

Skills: Must possess:

• 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).

• Ability to work under limited supervision, determine personal work plan, and schedule tasks and activities accordingly.

• Ability to accommodate shifting priorities, demands and timelines.

• Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating.

• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.

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.

Awards and Accolades:

America's Most Honored Businesses (Top 10%)

Awarded by USPAAC for Fastest Growing Business in the US

12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)

Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)

Top 100 by Dallas Business Journal (2020 and 2019)

Proven Supplier of the Year by Workforce Logiq (2020 and 2019)

2019 Spirit of Alliance Award by Agile1

2018 Best of the Best Platinum Award by Agile1

2018 TechServe Alliance Excellence Awards Winner

2017 Best of the Best Gold Award by Agile1(Act1 Group)

Regards,

Kajal Singh

Senior IT Recruiter (Pharma and Life Sciences)

Net2Source Inc.

Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA

Office: [phone] x 980 | Cell: [phone] | Fax: [phone]| Email: [e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Writing/Editing, Manufacturing, and Research

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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