Senior Medical Writer

Job#: 2042862

Job Description:

Job Title: Senior Medical Writer

Location: Remote

Job Summary: The Senior Medical Writer (SMW) will work independently and collaboratively with team members to write and review various regulatory and clinical documents. These documents include Clinical Study Reports (CSRs), protocols, protocol amendments, Informed Consent Forms (ICFs), narratives, Investigator’s Brochures (IBs), and IB updates across multiple therapeutic areas. The SMW is responsible for driving document development, managing timelines, and ensuring adherence to regulatory guidelines and document standards.

Key Responsibilities:

• Independently and collaboratively create and review content for within-scope documents, including CSRs, protocols, protocol amendments, ICFs, narratives, IBs, and IB updates.
• Write or contribute to other regulatory documents such as Clinical Summaries and Briefing Documents.
• Represent Medical Writing at project meetings, driving document development, articulating document strategy and timelines, and synthesizing key messages.
• Resolve issues, foster collaboration, and manage conflicts as necessary.
• Track project deliverables and ensure timely document completion.

Qualifications:

• Experience: Minimum of 12 years of industry experience.
• Skills:
  • Strong knowledge of the clinical research process and regulatory guidelines.
  • Proficient in scientific and technical reading, writing, and editing.
  • Well-developed organizational, interpersonal, and communication skills.
  • Ability to develop and present varied and unique ideas.
  • Proficient in MS Word, Adobe Acrobat, Project, PowerPoint, and electronic document management systems.
• Education: BA or BS degree required; advanced degree preferred.
• Languages: Proficiency in English (speaking, reading, writing).

Skills and Experience:

• Clinical Research
• Therapeutic Areas
• Acrobat
• Document Management
• Regulatory Documents

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.