[Hiring] Senior Medical Writer/Principal Medical Writer @Precision Medicine Group

Role Description

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

• Clinical document planning, writing, editing/formatting, and performing QC review.
• Developing documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements.
• Completing MW activities with impeccable attention to detail.
• Ensuring smooth and effective document management from start to finish in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments.
• Independently formulating key messages from clinical study data.
• Authoring complex content using knowledge/skills and understanding of processes.
• Communicating clearly and concisely both in writing and verbally with internal and client teams.
• Contributing to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents.
• Performing literature-based research to support writing activities.
• Other duties as assigned.

Qualifications

• 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.
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
• Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and eCTD requirements 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).
• Preferred: Oncology and/or rare disease experience (especially protocol and CSR development).

Company Description

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.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

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. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.