Position Summary: The Senior Medical Writer/Principal Medical Writer will be responsible for leading the development of high-quality and on-time clinical study documents.

Responsibilities

include clinical document planning, writing, editing/formatting, and performing QC review.

Requirements

. The successful candidate has a clear understanding of content

for key clinical documents based on regulatory

for all phases of development and will complete MW activities with impeccable attention to detail.

based on regulatory guidance's Ensures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments Ability to independently formulate key messages from clinical study data Ability to author complex content using knowledge/skills and understanding of processes Ability to communicate clearly and concisely both in writing and verbally with internal and client teams Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents Excellent problem-solving skills Performing literature-based research to support writing activities Other duties as assigned

for all phases of development Impeccable attention to detail and ability to complete writing assignments in a timely manner Ability to work effectively in a fast-paced environment with multiple high-priority projects with no instruction on routine work and minimal instruction on new assignments Preferred: Advanced degree (MS/PhD) Oncology and/or rare disease experience (especially protocol and CSR development) Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer.

Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. com . Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers.

Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process.

Qualifications

: Minimum Required: BS degree or equivalent in a scientific or medical discipline with relevant writing expertise 5+ years of experience as a Sr. Medical Writer in the sponsor and/or CRO setting or 7+ years of experience as a Principal Medical Writer.

Requirements (Ie, EudraCT, CT.Gov)

, and eCTD