Description

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 formatKnowledge of clinical trial and drug development processesKnowledge of and/or ability to quickly assimilate US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissionsMaintain 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/communicationsWorking knowledge of current electronic document management systems and publishing systemsAbility to assimilate, interpret and translate information/data for appropriate audiencesEnsure 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 environmentExcellent scientific and technical reading, writing, and editing skillsAbility to learn fast, grasp the 'essence' of a story quickly to convert relevant scientific data/information into high quality summaries and reportsExcellent 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.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.