Medical Writer

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

Job summary

Join a forward-thinking company as a Medical Writer, where your expertise will shape the future of drug development. This role offers the chance to manage and support critical projects in a dynamic environment, ensuring compliance with regulatory standards while enhancing your skills in technical writing and project management. Collaborate with a talented team to produce high-quality scientific documents that drive clinical development forward. With a commitment to innovation and excellence, this position is perfect for professionals eager to make a significant impact in the pharmaceutical industry.

Qualifications

• 5+ years of experience in pharmaceutical/biotech regulatory document management.
• Bachelor’s degree in life sciences or related field is preferred.

Responsibilities

• Manage and support projects in accordance with established processes and SOPs.
• Provide editorial assistance for scientific and regulatory documents.

Skills

Understanding of clinical development process

Knowledge of US and international regulations

Technical writing skills

Quality control experience

Familiarity with electronic document management systems

Excellent communication skills

Project management skills

Proficiency in Microsoft Office Suite

Education

Bachelor’s degree in life sciences or related field

Tools

VeevaVault

SharePoint

EndNote

Job description

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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 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.

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 providing project management, editorial, and QC assistance with scientific and regulatory documents related to clinical development of drugs and biologics; leading or supporting Medical Writing process improvement initiatives; managing the development and update of SOPs, templates, and guidance documents.

Primary Duties & Responsibilities:

• Provides editorial assistance, including editing and formatting in alignment with the Authoring Style Guide, for scientific and regulatory documents related to clinical development.
• Supports project management activities for scientific and regulatory document preparation, including tracking and compiling appendices for clinical study reports.
• Performs ad hoc QC requests on R&D documents, working closely with R&D team members.
• Leads or supports Medical Writing process improvement initiatives collaboratively with other medical writers and R&D groups.
• Manages development and updates of medical writing SOPs, templates, and guidance documents.

Skills: Must possess:

• Understanding of clinical development process and pharmaceutical project management standards.
• Knowledge of US, ICH, and international regulations for scientific and clinical/regulatory documents.
• Familiarity with Common Technical Document templates and content expectations for IND/NDA/MAA submissions.
• Technical writing skills: ability to self-edit and improve documents for clarity, accuracy, and consistency.
• Experience with style guides, including providing input on improvements; familiarity with AMA style preferred.
• Quality control experience in regulatory submission document review and finalization, including eCTD standards.
• Knowledge of electronic document management systems (e.g., VeevaVault, SharePoint) and publishing systems.
• Excellent communication, organizational, and interpersonal skills.
• Project management skills: ability to handle multiple projects, organize effectively, and manage time well.
• Proficiency in Microsoft Office Suite and reference management software like EndNote.
• Ability to work independently, prioritize tasks, and adapt to shifting deadlines.
• Strong interpersonal skills to motivate and elicit cooperation from diverse sources.
• Willingness to learn and apply new technologies and strategies.

Education:

Bachelor’s degree, preferably in life sciences, technical writing, or related field, with at least 5 years of experience in pharmaceutical/biotech regulatory document management.

Awards and Accolades:

Recognized for rapid growth and excellence, including awards from USPAAC, Staffing Industry Analysts, NJ Biz, INC 5000, and others.

Regards,

Kajal Singh

Senior IT Recruiter (Pharma and Life Sciences)

Net2Source Inc.

Address: 270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA

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

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Writing/Editing, Manufacturing, Research

Industries

• Biotechnology Research and Pharmaceutical Manufacturing