Clinical & Regulatory Medical Writer II

Planet Pharma; Aliso Viejo (CA); Sur place; USD 47 000 - 61 000; Plein temps

Résumé du poste

Planet Pharma in California is seeking a Medical Writer II to produce high-quality clinical and clinical regulatory documentation, translating complex data into clear reports. You will collaborate across departments, ensure adherence to regulatory guidelines, and develop conference abstracts, posters, and publications for internal and external stakeholders.

Requires 2–5 years of relevant experience, strong writing/editing skills, and a life sciences degree; ophthalmology experience preferred.

Qualifications

• 2–5 years of experience in clinical research, medical writing, or related life sciences fields.
• Strong knowledge of clinical research methodologies and medical terminology.
• Familiarity with regulatory requirements for clinical/regulatory documentation.
• Experience supporting CSRs, protocols, publications, abstracts, or posters preferred.
• Ophthalmology experience preferred.

Responsabilités

• Prepare CSRs under supervisor direction and ensure data consistency.
• Translate clinical study synopses into full clinical study protocols with input from teams.
• Interpret data and apply regulatory and scientific requirements to docs.
• Review, edit, and cross-check documents for accuracy.
• Stay current with industry trends and regulatory guidance.
• Coordinate with Clinical and R&D teams for abstracts and conferences.
• Create figures, tables, and visuals for publications and presentations.
• Manage multiple writing assignments and prioritize deliverables.

Connaissances

Strong writing

Editing

Proofreading

Organizational skills

Communication skills

Independent work

Formation

Bachelor’s degree in Life Sciences or related field

Advanced degree preferred

Outils

Microsoft Office

Adobe Acrobat

Document management systems

Description du poste

Planet Pharma in California is seeking a Medical Writer II to produce high-quality clinical and clinical regulatory documentation, translating complex data into clear reports. You will collaborate across departments, ensure adherence to regulatory guidelines, and develop conference abstracts, posters, and publications for internal and external stakeholders.

Requires 2–5 years of relevant experience, strong writing/editing skills, and a life sciences degree; ophthalmology experience preferred.