We are seeking a highly skilled Medical Writer II to join our team. This role requires an experienced professional with a strong background in writing, compiling, and editing medical documents. The ideal candidate will have expertise in writing Clinical Study Report (CSR) Narratives and a proven ability to mentor less experienced writers.

Roles and Responsibilities

Mentor less experienced medical writers on projects.
Compile, write, and edit medical writing deliverables with minimal supervision.
Develop or support a variety of documents, including Clinical Study Protocols, Clinical Study Reports (CSRs), Patient Narratives, and Investigator Brochures.
Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, and consistency.
Interact with various departments such as data management, biostatistics, and regulatory affairs to produce deliverables.
Serve as a peer reviewer on internal teams, ensuring document scientific content, clarity, and proper formatting.
Adhere to established regulatory standards, including ICH-E3 guidelines, and company SOPs.
Perform online clinical literature searches as applicable.
Maintain awareness of project budget specifications and communicate changes to leadership.
Stay updated with regulatory guidance and client expectations in medical writing.

Skills Required

Strong experience in medical writing, with a minimum of 3 years of relevant experience in Narrative writing.
Proven experience in independent authoring and reviewing CSR Narratives.
A Bachelor of Science or a Bachelor of Arts degree (Social Sciences, English, or Communications preferred) with relevant scientific and/or medical knowledge.
Extensive knowledge of English grammar and FDA and ICH regulations and guidelines.
Familiarity with AMA style guide.
A high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills.
Strong proficiency in Word, Excel, PowerPoint, email, and the Internet.
A working knowledge of the drug development process and regulatory guidelines.
The ability to interpret and present clinical data and other complex information.

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