Penfield Search Partners
Contact: Linda Aronova – laronova@penfieldsearch.com
Job Description: As a Senior Manager, in Global Regulatory Medical Writing, you will write and edit clinical regulatory documents, including submission summaries and other complex documents, provide intermediate-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.
Travel Requirements: International and Domestic Travel
Essential Duties & Responsibilities:
- Primarily work on the product/program level
- Write and edit clinical regulatory documents (all types)
- Possible to have direct reports; likely to oversee contingent workers and/or vendors; likely to provide training to others; and analyze needs to manage resources
- Offer leadership and fundamental accountability, provide strategic supervision, and planning assistance for clinical regulatory documents
- Ensure that documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
- Participate in the preparation/revision of document templates
Qualifications:
- Education/Experience: PhD or PharmD in life sciences (or other related field) with a minimum of 5 years of experience, or Master’s degree in life sciences (or other related field) with minimum of 7 years of experience
- Mastery of Microsoft (MW) Word
- Considered a competent manager with advanced regulatory medical writing expertise
- Possess advanced writing and editing skills and proficiency in using software, templates and other electronic formats
- Knowledgeable of government regulations pertaining to drug development, guidelines for document submissions, varied therapeutic areas, and statistical concepts
- Possess excellent written and oral communication skills
- Able to contribute to strategy under moderate supervision
- Able to tackle difficult problems; identify solutions and lead decisions to resolution
- Influence communication toward common understanding and actionable results
- Lead process development and improvement
- Manage and deliver assignments with quality and within timelines
- Provide input for budget planning