Director of Regulatory Medical Writing
Planet Pharma - MA, United States
Work at Planet Pharma
Overview
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Overview
2 weeks ago Be among the first 25 applicants
This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$250,000.00/yr - $270,000.00/yr
Additional compensation types
Annual Bonus, RSUs, and Stock options
Direct message the job poster from Planet Pharma
Trusted Recruitment Leader | Strategic Workforce Planner | Delivering Tailored Hiring Solutions for Clinical, Pharma, Biotech and Med Device…
Roles and Responsibilities:
- Managing focus
o Manage (80%) medical writers (in-house FTEs, contractors, and external vendors) who are contributing to MW activities for regulatory documents.
o Author (20%) content and project manage SME contributions for regulatory submissions, ensuring content is well-organized, consistent, accurate, and compliant with MW standards, SOPs, style guides, lexicons, templates, and libraries.
OR
- Writing focus
o Manage (20%) medical writers (in-house FTEs, contractors, and external vendors) contributing to MW activities.
o Author (80%) content and project manage SME contributions for regulatory submissions, ensuring quality and compliance.
Desired Skills and Experience:
- Bachelor’s degree in a scientific or clinical discipline; Ph.D. preferred.
- Minimum 7 years of sponsor-level pharma or biotech medical writing experience; CRO experience considered.
- Fluent in American English.
- Creative, effective problem-solving skills.
- Experience with eCTD Module 5 and 2 for global MAAs.
- Understanding of interdisciplinary organizational relationships.
- Leadership experience managing teams and direct reports.
- Basic scientific methodology knowledge applicable to drug development.
- Knowledge of regulatory guidance documents.
- Proficiency in proofreading for compliance.
- Strong analytical, summarization, and communication skills.
- Ability to prioritize, multitask, and work autonomously or collaboratively.
- Excellent time management and proficiency in MS Office.
Seniority level
- Director
Employment type
- Full-time
Job function
- Marketing, Health Care Provider, and Customer Service
Industries
- Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Biotechnology Research
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