Senior Specialist, Non-Clinical Pharmacology Document Writing Job...
MSD - South San Francisco, CA, United States, 94083
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Overview
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Overview
Job Description
We are currently hiring an experienced document writer to join our team in South San Francisco, CA.
The nonclinical pharmacology writing group prepares reports and submission modules to support development programs. The work covers all therapy areas and modalities from preparation for FIH through licensure. The role involves verifying data, writing pharmacology study reports, written summaries, and related documents, managing author/management reviews, ensuring documents meet regulatory compliance requirements, and ensuring documents and document packages are ready per the team’s planned submission dates.
Qualifications:
Education:
- Master's in biology, pharmacology, medicine or related fields with four (4) years of relevant experience listed below
- Ph.D. or MD in biology, pharmacology, medicine or related fields with two (2) years of relevant experience listed below
Required Experience and Skills:
- Strong writing skills and experience drafting study reports, scientific manuscripts, or scientific documents
- Experience with laboratory operations and data collection process
- Strong computer skills, especially MS Word
- Clear written communication
- Critical analytical skills
- Detail-oriented
Preferred Experience and Skills:
- A good understanding of therapeutic (small molecules, biologics, etc.) and/or vaccine development, including an understanding of the nonclinical aspects, e.g., pharmacology.
- Knowledge of pharmaceutical drug development with industry experience
- Proficient in Microsoft Office and GraphPad Prism
- A good understanding of the content of regulatory filings for nonclinical pharmacology in the context of CTD, IND, IMPD, NDA/BLA/MAA.
- American Medical Writers Association certification
Employee Status: Regular
Relocation: Domestic
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: 1st - Day
Valid Driving License: No
Hazardous Material(s): No
Job Posting End Date: 02/28/2025
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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