Nonclinical Medical Writer
33 Arch Street, 32nd floor Suite 3201 Boston, MA 02110 US
Job Description
For the expansion of their team, our client is looking for a medical/scientific writer to support nonclinical writing activities for regulatory submissions. The PharmTox BA group specializes in nonclinical toxicology and pharmacology, as well as bioanalytical support for nonclinical and clinical studies.
The role will report to the Global Head of Medical Writing. Remote working is possible, with a preference for this person to be located in the Central European Time (CET) zone.
Key Accountabilities/Responsibilities:
- Author the nonclinical parts of regulatory documents in collaboration with nonclinical SMEs (ie, toxicologist, clinical scientist, nonclinical PK scientist). Ensure the nonclinical sections of these documents are well-organized, accurate, up-to-date, consistent, compliant with applicable regulations, and written according to argenx medical writing standards
- Prepare timelines, lead drafting and review cycles of nonclinical regulatory documents (eg, Modules 2.4.x and 2.6.x, nonclinical briefing books)
- Attend PharmTox-BA meetings to understand the nonclinical problematics and have an overview of the ongoing nonclinical study timelines
- Participate in maintaining critical document timelines by working with the Project Manager, Regulatory Lead, Head of PharmTox-BA, and other medical writers to ensure project deadlines are met
- Collaborate with project teams to ensure project deadlines are met by providing content development support, research, and editing functions for each program
- Support the development and maintenance of nonclinical template documents
- Collaborate with RegOps and nonclinical SMEs to ensure the availability of nonclinical documentation before a regulatory submission (eg, support Module 4 preparation)
- Review and edit in-house nonclinical study reports that are intended for regulatory submission, to ensure quality of final documentation (non-GLP, toxicology, pharmacology, and pharmacokinetics where appropriate)
- Bachelor's degree in a scientific or medical discipline (PhD preferred)
- Minimum of 1-3 years of experience in a similar position, eCTD development experience preferred
- Proficiency in MS Office software applications such as Outlook, Excel, and PowerPoint, excellence in word
- Team player and good communication skills
- Understands FDA/international regulations, ICH guidelines (including expectations for CTDs), white papers detailing technical expectations
- Flexible attitude, able to manage multiple parallel tasks
- Knowledge of nonclinical safety is a plus
- Knowledge of GLP is a plus
- Excellent written and verbal communication skills (native/bilingual or fluent American English proficiency)
- Experience with Veeva vault and Please Review (or similar systems) preferred
- Experience writing for biologics preferred
- Basic understanding of scientific methodology, with the ability to understand clinical development and eCTD structure, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
- Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
- Ability to proofread documents for compliance with internal and external guidance documents
- Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion
- Ability to work precisely according to procedures and regulations
- Excellent written and verbal communication skills
- Ability to prioritize and multi-task successfully in a fast-paced environment
- Ability to work autonomously, as well as in a team
- Excellent time management skills and a proven ability to work on multiple projects at any given time
- Must be proficient in MS Office
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