US-TX, Senior Medical Writing Group Lead 212022BR-MZ
212022BR
Senior Medical Writing Group Lead
Global Drug Development
GDO GDD
USA
Fort Worth, TX
Novartis Pharmaceuticals
Research & Development
Full Time
Regular
The Senior Medical Writing Group Lead manages and leads the medical/science/technical writing team(s) in one or more franchise groups; focuses on production of clinical study reports, investigator s brochures, clinical evaluation reports (CERs) (including all components), and ancillary technical documents supporting global submissions and filings; responsible for developing writing initiatives and training of Document Excellence (DE) organization producing high quality documents.
Responsibilities:
1.Primary:
Ensure quality and timely development of clinical study reports and/or CERs
Responsible for multiple initiatives and training to further promote quality documentation
2.Secondary:
Facilitate harmonization of technical documentation (templates)
Typically manage medical writers (5-10) to meet resource demands
Review protocols and MOPs to assure compliance with external standards
Facilitate workflow and timely completion of Investigator s Brochure
Integration of study reports into submission documents
Provide writing support for additional regulatory documents (eg, technical reports, and other relevant submission documents)
Lead Process
Establish standards of writing for responsible business area
Ensure Novartis compliance to internal and external guidance for technical documentation
Establish templates to ensure consistency of quality documentation
Ensure harmonization and transparency of processes for assigned business areas
Recruit medical writers, manage performance, set direction, align and motivate team members to achieve set goals and objectives
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Education:
PhD, MD, OD, PharmD (or equivalent)
Language:
Fluent in English is essential
Experience/Skills:
Excellent written and oral skills
Knowledge of ophthalmic medical devices preferred
The individual must have strong understanding of study design, analytical and data interpretation, and reporting skills
In-depth knowledge of clinical regulatory requirements for clinical regulatory documentation
Minimally 5-10 years medical writing experience or other relevant Device industry experience.Exhibits skills for supervising medical writers
Ability to coach, mentor, and lead global cross-functional teams, strong leadership skills and previous line management experience
Extensive experience of data interpretation and presentation of regulatory documents for clinical development programs
Expertise in the preparation of documents for submission to health authorities in support of marketing applications
Excellent knowledge of regulatory document requirements, creation, management and publishing processes and tools
Experience with matrix management and global environment
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