[Hiring] Senior Medical Writer @Precision for Medicine

Role Description

The Senior Medical Writer (MW) 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.

Essential functions of the job include but are not limited to:

• Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidances.
• Ensuring 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.
• Contributing 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.

Qualifications

• Minimum Required:
  • BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.
  • 5+ years of experience as a medical writer in the sponsor and/or CRO setting.
• Other Required:
  • 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).
  • Oncology and/or rare disease experience (especially protocol and CSR development).

Requirements

• Salary Range: $101,800 - 152,600.
• This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

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].

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.