Director of Regulatory Writing

Director of Regulatory Writing
Position Summary
The Director of Regulatory Writing is a managing professional responsible for the creation of regulatory materials for investigation and marketed products. The individual will also implement and manage regulatory writing projects and supervise Regulatory Writing Specialists in the completion of these projects. The individual also participates in the strategic planning of the Regulatory Writing department.
Essential Functions
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Essential Functions Statements
Leads the Regulatory Writing staff in the development of clinical study protocols, clinical study reports, briefing documents, and IND, NDA, and MAA components across a variety of therapeutic areas and other writing projects.
Maintains active and ongoing contact with existing clients regarding regulatory and clinical trial project work.
Acts as a primary writer and/or project manager for key documents and projects.
Works with global Medical and Regulatory experts to understand, interpret, and apply the clinical considerations and regulatory strategies pertinent to document development.
Works with clients and internal departments to develop timelines for regulatory writing projects.
Involved in determining and presenting the scope of work with the business development staff and potential clients when appropriate.
Supervises the daily activities and performance of the Regulatory Writing Specialists.
Serves as key contact for communication between the clients and each of the Med Communications teams.
Supports Quality Assurance activities.
Takes action to include self-training, creating or revision of new work instructions, or other measures to ensure Med Communications compliance with Client quality guidelines and key performance metrics.
Identifies, initiates, and monitors to completion, any regulatory and related writing projects.
Coordinates the work schedule for existing clients, the scheduling of meetings and training sessions, and ensures that all required training requirements are met by all team members.
Coordinates the schedule of Regulatory Writing Specialists.
Plans and monitors the resource allocation for team members.
Provides key input related to the hiring of new Professional Staff.
Identifies new opportunities for client-related services.
Supports Business Strategies, including attendance at conferences and travel in the development of new services and sales related to existing services.
Position Qualifications
Competency Statements
Ethical - Ability to conform to a set of values and accepted standards.
Accountability - Ability to accept responsibility and account for his/her actions.
Accuracy - Ability to perform work accurately and thoroughly.
Analytical Skills - Ability to use thinking and reasoning to solve a problem.
Detail-Oriented - Ability to pay attention to the minute details of a project or task.
Self -Motivated - Ability to be internally inspired to perform a task to the best of ones ability using his or her own drive or initiative.
Organized - Possesses the trait of being well organized or following a systematic method of performing a task.
Tactful - Ability to show consideration for and maintain good relations with others.
Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
Project Management Ability to develop and complete a project in a timely manner.
Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
Customer-Oriented - Ability to take care of the client needs while following company procedures.
Communication, Written - Ability to communicate clearly and concisely in writing.
Communication, Oral - Ability to communicate effectively and professionally with others using the spoken word. Ability to present information to clients and potential clients via in-person, videoconference or phone presentations.
Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience.
Working Under Pressure - Ability to complete assigned tasks under stressful situations.
Regulatory Understanding Ability to apply regulatory and compliance guidelines to drug information industry.
Drug Information Proficiency in drug information communication and management.
Sales and Marketing Ability to identify and actively pursue new business relationships for Med Communications through interpersonal communication and development of marketing materials.
Skills and Abilities
Education: Advanced degree in Pharmacy or relevant work experience; or equivalent combination of education, training and experience.
Experience: Ten years of related experience preferred.
Computer Skills: Prefer proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
Work Environment
Remote / Teleworking or Med Communications, Inc.
Memphis, TN
The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.
Disclaimer
By attaching your Curriculum Vitae (RESUME), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. . Please read this policy carefully for more information on your rights regarding personal data protection. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.
Recruitment Agency Notice:
Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes. Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy. Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.