Senior Medical Writer – FSP

Medical writerMedical writerFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

12 days ago

Salary

Not specified

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

• Leads cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external questions • Develops, coordinates, and oversees work plans for both individual and multiple-document delivery • Prepares clinical study reports (CSRs), protocols, investigator brochures (IBs), submission data summaries, and other regulatory documents • Works as an active member of cross-functional teams representing Medical Writing

Job Requirements

  • Minimum 5 years in writing regulatory documents supporting global filings
  • Oncology and/or Infectious Disease/Vaccines experience
  • Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the EU and US
  • Bachelor's degree or equivalent (Life Science preferred)
  • Fluent in reading and writing American English.

Benefits

  • Health insurance
  • Professional development
  • Work from home options

Related Categories

Related Job Pages

More Medical writer Jobs

24-MAG logo

Health & Medicine Expert

24-MAG

This opportunity is available through a leading AI-driven work platform.

Medical writer12 days ago
ContractRemote

This role involves contributing expertise to a large-scale AI training initiative focused on improving medical reasoning, clinical knowledge application, and healthcare-related analysis in advanced AI models. Author health and medicine prompts covering clinical reasoning, diagnos...

clinical reasoningdiagnosis differentialstreatment planningpharmacologypatient educationclinical guidelineshealthcare regulatory frameworksclinical documentation
United States

Clinical Support Specialist - 485 Review - Part-Time

BAYADA Home Health Care

Established in 1975, BAYADA is a non-profit organization that has never been sold, caring for an average of 44,000 clients weekly with 31,500 employees onboard. BAYADA is serving clients in 21 states, 373 offices, 6 countries and growing!!! As an accredited, regulated, certified, and licensed home health care provider, BAYADA complies with all state/local mandates. BAYADA is celebrating 50 years of compassion, excellence, and reliability. Learn more about our 50th anniversary celebration and how you can join in here . BAYADA Home Health Care, Inc., and its associated entities and joint venture partners, are Equal Opportunity Employers. All employment decisions are made on a non-discriminatory basis without regard to sex, race, color, age, disability, pregnancy or maternity, sexual orientation, gender identity, citizenship status, military status, or any other similarly protected status in accordance with federal, state and local laws. Hence, we strongly encourage applications from people with these identities or who are members of other marginalized communities.

Medical writer12 days ago
Full TimeRemoteTeam 10,001

This role is responsible for reviewing and ensuring the accuracy, timeliness, and compliance of OASIS documentation for Start of Care, Recertification, and Discharge assessments. Key duties include validating 485 plans of care, scrubbing OASIS items, conducting medication reconciliation, and providing targeted education to clinical staff.

United States
$40 - $43 / hour
UW Health logo

RN - Outpatient Clinical Documentation Specialist

UW Health

UW Health is committed to fostering a workplace that creates belonging for everyone and is an Equal Employment Opportunity (EEO) employer. Our respect for people shines through patient care interactions and our daily work practices as we work to embrace the knowledge, unique perspectives and qualities each employee and faculty member brings to work each day.

Medical writer12 days ago
Full TimeRemoteTeam 5,001-10,000

The Registered Nurse will advise clinicians on complete and accurate Outpatient/Clinic documentation, focusing on HCC capture, and function as a liaison between clinicians and coders. This role involves conducting pre and post-visit reviews of medical records to seek documentation clarification, serving as an expert source on documentation impact on patient care and reimbursement.

United States
Full TimeRemoteTeam 5,001-10,000H1B Sponsor

The specialist supports the delivery of Clinical Trial Transparency activities for assigned studies, managing compliant disclosure of registration and results information on public registries. This includes contributing to process improvement, maintaining standard operating procedures, and supporting vendor oversight for timely and high-quality disclosure activities.

United States
$84K - $110K / year