What are the responsibilities and job description for the Sr. Medical Writer position at Actalent?
IMMEDIATE NEED for 100% Remote Medical Writer Openings to join globally leading CRO!
Summary:
Responsible for preparation and coordination of clinical study protocols and clinical study reports (CSRs), and other documents as needed. Provide support for and participate in development of submission level documents under guidance of sr staff. Production of scientific publications and other documents (e.g., abstracts, posters, manuscripts, etc.). Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Oversees and coordinates activities of other writers on higher complexity narrative projects. Ensure timely delivery of high quality documents to internal customers and Sponsors.
• Write and coordinate the development of protocols, CSRs or other clinical documents including those of a more complex nature
• Provide support in development of submission level documents under guidance of sr staff
• Oversees management and coordination of complex narrative projects
• Produces scientific papers, abstracts and/or posters, and presentations.
• Responsible for all medical writing aspects of project development and coordination, adherence to timelines and budget
• To prioritize and plan workload to a high standard. Effectively manage multiple assignments in parallel
• Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
• Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
• Act as medical writing contact for major clients and partners
• Keep up to date with developments in Medical Writing
• In consultation with more experienced staff, show initiative and ability to deal with complex project situations
• Inform management of medical writing problems promptly and propose solutions
Minimum Qualifications:
• Typically minimum 4 years medical writing experience including 2 years as medical writing project lead
• Excellent command of written and spoken English
• Excellent written and verbal communication skills
• In-depth knowledge of MS Word
• Excellent organizational and time management ability
• Detailed knowledge of ICH guidelines applicable to medical writing
• Good understanding of medical/scientific terminology and experience in data analysis and interpretation
Additional Benefits:
- 100% Remote!
- Quick Access to Benefits: Medical, Vision, Dental, 401(k)
- PTO/Holiday Pay
- Actively interviewing!
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Compensation is tied to the Colorado market for jobs performed in Colorado. Other locations may be subject to variances based on locations-related factors. We reserve the right
to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:
- Medical, dental & vision
- 401(k)/Roth
- Insurance (Basic/Supplemental Life & AD&D)
- Short and long-term disability
- Health & Dependent Care Spending Accounts (HSA & DCFSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
