Senior Medical Writer (Contract)

Sitero LLC

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. 

Job Title: Senior Medical Writer    

Location: United States (Remote)                

Function: Medical Writing             

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Senior Medical Writer will play a pivotal role in developing high-quality medical and clinical documents that support regulatory submissions and publications. This position requires a seasoned professional with expertise in medical writing, regulatory standards, and authoring clinical study reports.

Document Development:

• Lead the creation and editing of various documents, including:
  • Clinical Study Protocols and Amendments
  • Clinical Study Reports
  • Informed Consent Forms
  • Regulatory Submission Documents (e.g., INDs, NDAs, CTDs)
  • Investigator Brochures
  • Clinical and Statistical Summaries
  • Scientific Publications (e.g., abstracts, manuscripts)
  • Patient Narratives

Project Leadership:

• Serve as the primary medical writing contact for assigned projects.
• Collaborate with cross-functional teams, including clinical, regulatory, and biostatistics departments.
• Ensure timely delivery of high-quality documents that meet client expectations and regulatory standards.

Regulatory Compliance:

• Stay updated with current industry practices, regulatory requirements, and guidelines affecting medical writing.
• Ensure all documents adhere to relevant regulatory standards, including ICH and GCP guidelines

Client Interaction:

• Participate in client meetings and presentations.
• Address client feedback and incorporate revisions as necessary.

EDUCATION AND EXPERIENCE REQUIRED:

·       Advanced degree in a scientific discipline (PhD, PharmD, MD) preferred; a minimum of a bachelor's degree in life sciences is required.

·       At least 5 years of professional experience in medical writing within the pharmaceutical, biotechnology, or CRO industry.

·       Extensive experience writing and editing CSRs is required

·       Demonstrated expertise in writing regulatory documents and scientific publications.

·       Therapeutic experience in Hepatology strongly preferred.

COMPENSATION & BENEFITS:

Sitero proudly offers a competitive Contractor hourly rate for this position

EMPLOYMENT TYPE:

Part-Time Contract.  20-40 hours per week

COMMITMENTS:

Flexibility to scale hours between 20-40 hours per week depending on project initiatives 

DISCLAIMER: 

Sitero is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.