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Senior Medical Writer

Net2Source

Florham Park, NJ(remote)

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JOB DETAILS
SALARY
$75–$81.70 Per Hour
SKILLS
Agile Programming Methodologies, Biology, Biotech and Pharmaceutical, Brochures, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Support, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Document Management, Drug Development, FDA Requirements, Fortune 500 Customers, Healthcare, Healthcare Quality, ICH Regulations, Industry/Trade Analysis, Lead Generation, Leadership, Medical Office Administration, Medical Products, Medical Writing, New Drug Application, Nursing, Outsourcing, Pharmacovigilance, Pharmacy, Presentation/Verbal Skills, Problem Solving Skills, Product Marketing, Product Support, Project/Program Management, Protocol Design, Quality Assurance, Regulations, Regulatory Submissions, Standard Operating Procedures (SOP), Startup, Style Guide, Team Player, Time Management, Women's Health, Writing Skills
LOCATION
Florham Park, NJ
POSTED
12 days ago
Join a Global Leader in Workforce Solutions – Net2Source Inc.

Who We Are
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.

Job Title: Medical Writer/Clinical - II (Associate)
Location: Remote
Duration: 12 Months Contract

Pay Rate: $75-80/Hr on W2

Shift: Monday-Friday (8:00 AM to 5:00 PM) – 40.00 Hours/Week  
 
(Job Details)
 
Qualifications:
Senior Medical Writer
Organon is a Women's Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women's health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
 
We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It's going to be an exciting future—come be a part of it!
 
Education Minimum Requirements:
• Bachelor of Science Degree in Life Sciences or Health Care Professions (Nursing/ Pharmacy) or related discipline.
• Master's degree / PhD / PharmD preferred.
 
Required Experience and Skills:
• At least 7 years of medical writing experience in pharmaceutical industry.
• Experience as lead writer for key documents included in major US/EU and/or international regulatory submissions required.
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
• Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
• Must have proven track record to be able to think critically, strategically, independently and solve problems.
• Must have high level of motivation, drive, and demonstration of our new company's leadership values.
• Excellent time and project management skills.
• Excellent written and verbal communication skills including the ability to write clearly and concisely.
• Top notch interpersonal skills in difficult situations.
• Ability to collaborate across multiple functional areas.
 
Responsibilities:
This role is accountable for Medical Writing (MW) and is part of the Regulatory Operations organization.
 
The successful candidate should expect to provide medical writing of clinical regulatory documents supporting components across various types of regulatory filings, including but not limited to: Investigator's brochures, Protocol & Protocol Amendments, CSR, Agency Background Packages and Response to Agency Inquiry, clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions, and other types of clinical and regulatory documents within the working scope of medical writing.
This position will be for a member of the Medical Writing Team, reporting into the Head of Medical Writing.
 
Primary Responsibilities:
• Manage the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as Organon's SOP/WI(s), template(s), and style guide.
• Manage multiple documents at the same time, and ensures timely and high-quality completion of Medical Writing deliverables that include the proper content and context and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• Initiate and lead strategy/resolution meetings when required
• Drive interaction and clear handoffs between stakeholder organizations (Clinical, Safety, Regulatory, Non-Clinical) to the MW team.
• Support and drive partnering with vendors to provide Medical Writing support.
• Contribute to the development, alignment, and consistent implementation of processes.
• Responsible for following processes and being inspection-ready.
• Contribute to the preparation/revision of document templates, development of process, and preparation/revision of standard operating procedures (SOPs) and guidance documents.
• Develops and drives process supporting content authoring, quality assurance and formatting to a standard within the global content authoring platform.
• Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities, if required.
 
Notes:
100% REMOTELY BASED.

Why Work With Us?
We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.

Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.

Awards & Recognition
• America's Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1

#LS01

About the Company

N

Net2Source

Net2Source Inc. is a Global Workforce Management Solutions Company, headquartered in New Brunswick, NJ with its local offices in Texas, California, Florida, Illinois, Colorado and Michigan and its global operations in Canada, UK, Europe, UAE, Malaysia, Australia, China, Singapore and India. Net2Source offers a wide gamut of consulting solutions customized to specific client needs including but not limited to Application Development, Workforce Management and Project Consulting. Whether it’s a Fortune client, whether it’s a System Implementer or whether it is a Start -up, our recipe to success – Exceed expectations! Under promise, over deliver.
COMPANY SIZE
50 to 99 employees
INDUSTRY
Other/Not Classified
WEBSITE
http://www.net2source.com