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Remote Medical Writer wanted | $100 to $105 per hour
🕑 Added 2025-08-07 14:22:17 +0000 UTCCOMPANY/PUBLICATION: ACTALENT
Deadline: 20 August 2025
Our client is seeking an experienced Medical Writer to support the development and completion of Clinical Study Reports (CSRs) for its CNS focused clinical programs. The ideal candidate will have a strong background in regulatory medical writing, particularly in completion of pending CSRs in accordance with ICH E3 guidelines.
Draft, revise, and finalize Clinical Study Reports (CSRs) for Phase 1–3 clinical trials.
Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Regulatory Affairs, and Medical Affairs.
Interpret clinical data and translate complex scientific findings into clear, accurate, and regulatory-compliant documents.
Serves as a subject matter expert within department for assigned therapeutic/product areas.
Ensure consistency with protocol, statistical analysis plan (SAP), and other source documents.
Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
Knowledge of clinical trial and drug development processes
Knowledge of and/or ability to quickly assimilate US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissions
Maintain version control and manage timelines to meet submission deadlines.
Participate in quality control (QC) reviews and respond to internal and external feedback.
Provide review of product and disease state materials/communications
Working knowledge of current electronic document management systems and publishing systems
Ability to assimilate, interpret and translate information/data for appropriate audiences
Ensure all documents meet internal quality standards and regulatory requirements.
Participate in cross-functional meetings to align timelines, content, and strategy for NDA submission.
Knowledge of FDA, Health Canada and European drug regulations.
Ensure materials are scientifically accurate, on-label, and compliant with FDA, PhRMA, and global regulatory standards.
Interprets and summarizes data from biostatistical summary tables and listings accurately, precisely and concisely into narrative text.
Performs additional duties or assignments and special projects as directed by management.
May be asked to support direct client projects on an ad hoc basis, depending on requirement and resource allocation.
ADDITIONAL SKILLS & QUALIFICATIONS
Advanced degree (PhD, MD, PharmD) in life sciences, medicine, or a related field.
Minimum 10 years of experience in medical writing with a focus on CSRs.
Strong knowledge of ICH E3 and regulatory submission requirements (FDA, EMA).
Experience with CNS therapeutic areas (e.g., ADHD, epilepsy, depression) is highly desirable.
Proficiency in Microsoft Word and document management systems (e.g., Veeva Vault, SharePoint).
Skilled at creating a cooperative team environment
Excellent scientific and technical reading, writing, and editing skills
Ability to learn fast, grasp the 'essence' of a story quickly to convert relevant scientific data/information into high quality summaries and reports
Excellent verbal communication skills.
Knowledgeable in statistical outputs and clinical trial data.
Ability to work independently and manage multiple projects simultaneously.
Experience working in a biotech or pharmaceutical environment with cross-functional teams.
PAY AND BENEFITS
The pay range for this position is $100.00 - $105.00/hr.
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. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
WORKPLACE TYPE
This is a fully remote position.
APPLICATION DEADLINE
This position is anticipated to close on Aug 20, 2025.
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CONTACT INFORMATION:
Original job posting: Click here
Website: https://www.actalentservices.com
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