Outsmart Your Disease™

Medical Writer

Medical writerMedical writerFull TimeRemoteTeam 501-1,000H1B No SponsorCompany Site LinkedIn

Location

California

Posted

116 days ago

Salary

$100K - $110K / year

Bachelor Degree1 yr expEnglish

Job Description

• Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents. • Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents. • Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients. • Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents. • Lead document review meetings and discussions. • Provide direction and solutions to cross-functional teams on expectations for document content. • Perform QC of clinical and nonclinical documents. • Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines. • Participate in project team meetings. • Performs other duties as assigned.

Job Requirements

A bachelor’s degree in science-related fields with 1+ years of experience is required;
A master’s degree in science-related fields with some experience is required.
1+ year of medical writing experience preferred.
Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions required.
Strong scientific background in oncology, immunotherapy, or related field required.
Proficient knowledge of AMA writing guidelines.
Excellent verbal and written communication skills in English.
Knowledge of FDA, EMA, and ICH guidelines.
Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously.
Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
Ability to work collaboratively in a dynamic environment.
Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates.

Benefits

Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day