Senior Medical Writer/Principal Medical Writer

Title: Senior Medical Writer/Principal Medical Writer

Company: Precision for Medicine
Location: Canada
Job Type: FullTime

Description:

The Senior Medical Writer/Principal Medical Writer is responsible for leading the development of high-quality clinical study documents, ensuring compliance with regulatory guidelines and internal standards. Key responsibilities include planning, writing, editing, and performing QC review of clinical documents, as well as managing document processes effectively.

Qualifications:

BS degree or equivalent in a scientific or medical discipline

5 years of experience as a Sr. Medical Writer or 7 years as a Principal Medical Writer

Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint

Clear understanding of regulatory guidelines and clinical trial transparency requirements

Impeccable attention to detail and ability to work in a fast-paced environment

Preferred: Advanced degree (MS/PhD) and experience in oncology or rare diseases

The compensation range for this role is $101,800 - $184,700, with additional benefits such as a discretionary annual bonus, health insurance, retirement savings, parental leave, and paid time off. Precision Medicine Group is an Equal Opportunity Employer and values diversity in its workforce.

If you require a reasonable accommodation during the application process or have concerns about recruitment fraud, please contact Precision Medicine Group at myHR@precisionmedicinegrp.com.

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Title: Senior Medical Writer/Principal Medical Writer
Company: Precision for Medicine
Location: Canada
Position Summary:

The Senior Medical Writer/Principal Medical Writer will be responsible for leading the development of highquality and ontime clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete 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 highquality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements 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 problemsolving skills
 Performing literaturebased 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 Sr. Medical Writer in the sponsor and/or CRO setting or 7 years of experience as a Principal Medical Writer.

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 fastpaced environment with multiple highpriority 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)

Precision is required by law in some states, cities and or countries to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. 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.

Salary Range: 101,800  184,700

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.

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 myHR@precisionmedicinegrp.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. 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 myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

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