Senior Medical Writer

Our client, a leading organization in the pharmaceutical and biologic development industry, is seeking a Senior Medical Writer to join their team. As a Sr. Med Writer, you will be part of the Regulatory Affairs department supporting clinical development projects. The ideal candidate will demonstrate strong communication skills, attention to detail, and a proactive approach, which will align successfully in the organization.

Job Title: Senior Medical Writer

Location: 100% Remote (East coast preferred)

Pay Range: $72-81/hr.

Job Type: 6-month contract with the potential for hire/extension

Schedule: M-F 40 hours/week (could be less depending on workload)

What's the Job?

• Serve as a primary author, providing strategic input and authoring regulatory documents supporting Phase 1-3 clinical drug development, including clinical study protocols, protocol amendments, and Clinical Study Reports (CSRs).

• Research, author, and/or edit complex clinical, scientific, and program-level regulatory documents such as Investigators Brochures (IBs), Investigational New Drug (IND) application documents, and Marketing Authorization Application (MAA) documents.

• Review documents prepared by junior writers and peers, offering guidance and mentorship on document development, regulatory requirements, and therapeutic area knowledge.

• Ensure all documents comply with quality standards, regulatory requirements, and client-specific standards, while developing best practices to optimize document quality and delivery.

• Support program management activities, including developing timelines, managing budgets, forecasts, and contract modifications, and addressing out-of-scope activities.

What's Needed?

• Bachelor's degree in a scientific discipline or equivalent; advanced degrees preferred.

• Minimum of 5+ years of relevant experience in medical writing or regulatory document development.

• Experience working within the pharmaceutical or CRO industry is preferred.

• Additional qualifications in medical writing (e.g., AMWA, EMWA, RAC) are advantageous.

• Excellent data interpretation, medical writing, and editing skills, along with strong project management abilities.

What's in it for me?

• Opportunity to work on impactful clinical development projects in a dynamic environment.

• Collaborate with a diverse and talented team of professionals.

• Engage in continuous learning and professional growth.

• Competitive pay rate aligned with industry standards.

• Work in a supportive environment that values innovation and excellence.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans

• Dental Plan

• Vision Plan

• Health Savings Account

• Health Flexible Spending Account

• Dependent Care Flexible Spending Account

• Supplemental Life Insurance

• Short Term and Long Term Disability Insurance

• Business Travel Insurance

• 401(k), Plus Match

• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis and Talent Solutions.

Experis® is a global leader in technology services and part of the ManpowerGroup® (NYSE: MAN) family of brands. We connect skilled technology professionals with meaningful opportunities where they can grow their careers, expand their expertise and make a real impact. Guided by the belief that it takes Human Ingenuity to unlock the true potential of technology, Experis helps people gain experience with leading organizations, build sought-after skills and take the next step toward a brighter future. Backed by ManpowerGroup's 75+ years of workforce expertise and global reach across more than 70 countries and territories, Experis brings the scale, insight and opportunity to help people and businesses thrive. ManpowerGroup is consistently recognized for its commitment to inclusion, ethics and responsible business, including being named one of the World's Most Ethical Companies. Learn more at Experis.com.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.