Sr Medical Writing Associate

Job Description

This role is located in Santa Monica CA.

As Sr Medical Writing Associate you will be responsible for the following.

Key Responsibilities:

• Prepare regulatory documents such as Phase 1 and Phase 2 Clinical Study Reports (CSRs) and Investigator’s Brochures (IBs) in compliance with regulatory requirements and internal standards.
• Work under the guidance of senior medical writers while independently managing projects of limited complexity.
• Assist in the development of additional document types, including Phase 3 CSRs, pediatric investigation plans, and regulatory response documents, under close supervision.
• Contribute to non-regulatory medical writing activities as needed.
• Represent the medical writing function on product or project teams with oversight from senior staff.
• Participate in submission teams, offering guidance on data presentation to meet document objectives.
• Support planning and resource allocation for assigned documents, including timeline reviews.
• Collaborate with cross-functional teams (e.g., Clinical Research, Biometrics, Virology) to ensure accuracy, completeness, and scientific integrity of source data.
• Coordinate final document compilation, ensuring all functional area contributions are complete and integrated.
• Contribute to the development and maintenance of document templates, standards, and medical writing processes.
• Build expertise in regulatory document preparation, particularly at the individual study report level.
  

Basic Qualifications:

• Bachelor’s degree required; advanced degree in life sciences preferred.
• 5+ Years with BS/BA
• 3+ Years with MS/MA
  

Preferred Qualifications:

• Bachelor’s degree (BS) in a relevant scientific discipline.
• Minimum of 3 years of experience in clinical research and development (R&D) or regulatory affairs within the pharmaceutical or biotechnology industry.
• At least 1 year of direct experience in medical writing or clinical submissions, including preparation of documents for regulatory submissions.
• Strong verbal communication skills and meticulous attention to detail.
• Adaptable communication style to effectively engage with diverse team members.
• Solid understanding of regulatory document requirements and industry guidelines.
• Proficiency in Microsoft Word, Adobe Acrobat, Excel, and document management systems (e.g., RDMS).
• Active participation in departmental meetings and collaborative initiatives.
  

People leader accountabilities

• Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.