Executive Director - Medical Writing

Position Location:  Jersey City, NJJob Summary:Responsible for all medical writing activities pertaining to clinical drug development, including documents for regulatory submissions to FDA.  Provide strategic guidance for medical writing and NDA submissions. Provide leadership on all departmental and company issues. Reports to Senior Vice President, Clinical Operations & Biometrics. Job Responsibilities:1. Manage overall functioning of Medical Writing (approximately 5 direct reports).2. Oversee coordination of medical writing activities with Biostatistics, Clinical Development, Clinical Pharmacology & Drug Dynamics, Regulatory Affairs, Statistical Programming, and Toxicology.3. Provide strategic guidance for medical writing and NDA submissions. 4. Actively participates on all submission teams.5. Appoint departmental representatives to clinical and study teams.6. Responsible for personnel decisions.7. Make decisions with respect to staffing assignments and requirements.8. Evaluate performance and set goals and objectives for reporting staff.9. Responsible for budgetary decisions.10. Implement company policies on employee relations.11. Assist and support the Senior Vice President, Clinical Operations & Biometrics (COB) in running COB. Additional Responsibilities:1. Works with Document Formats and Standards to ensure appropriate templates for protocols, protocol amendments, clinical study reports, and integrated summaries.2. Participating in vendor selection activities.3. Identify employee strengths and weaknesses and develop program for career development for all employees.4. Approves all departmental standard operating procedures, working documents, and job aids. Job Requirements:Education:  PhD, or equivalent required.Experience:  10+ years of relevant technical experience required.  Five (5) years of supervisory experience required.  Extensive experience in drug development and regulatory affairs, as well as budgeting and project management.Licensure/Credentials:  None.Knowledge, Skills, and Abilities:  1. Excellent verbal communication skills and a demonstrated ability to write effectively.2. Demonstrated leadership ability.3. Requires extensive experience with IND/NDA submissions, including eCTDs.4. Knowledge of Documentum and Microsoft Office.  If you are interested in this position, please apply directly at: http://www.frx.com/careers/job_description.aspx?number=92945 or you can review all of our open positions at:  www.frx.com/careers