Manager, Medical Writing and Scientific Communications for i3

UnitedHealth Group is an innovative leader in the health and well-being industry, serving more than 55 million Americans. Through our family of companies, we contribute outstanding clinical insight with consumer-friendly services and advanced technology to help people achieve optimal health.

i3 Statprobe provides a full range of data management and biostatistical services for the pharmaceutical and biotechnology industries. We not only pay relentless attention to the details, we also lend a broader perspective to a client's data management needs. We realize that strategy is just as important as process, and we provide a higher level of thinking for data management and biostatistics.



As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Statprobe can provide.



i3 Statprobe is seeking an experienced Manager, Medical Writing and Scientific Communications, to provide overall management/supervision of assigned direct reports, oversees medical writing and report processing, assures compliance with regulations and timely completion of deliverables to clients, and consults with internal and external customers, as needed.



Major Responsibilities

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.




Ensures timely completion and delivery of work product to clients.


Ensures quality of work product delivered to clients.


Documents quality findings in written monthly summary reports to Global Director of Medical Writing and Scientific Communications.


Develops and maintains departmental Standard Operating Procedures (SOPS) for medical writing and report processing services.


Works with other relevant line functions to prepare documents, including Phase I- IV clinical study reports, Investigator Brochures, eCTD modules, protocols, and informed consent documents.


Provides technical review of documents, including Phase I- IV clinical study reports, Investigator Brochures, eCTD modules, protocols, and informed consent documents.


Actively supports ongoing business development efforts related to medical writing and report processing services.


Participates in presentations to clients for general capabilities as well as specific project proposals as needed.


Participates in professional meetings to enhance and maintain industry recognition of i3 Statprobe's medical writing and report processing capabilities.


Assesses departmental resource needs, collaborating with Human Resources on hiring, retention, and termination activities.


Ensures departmental adherence to agreed upon standards, templates and formats and document management procedures, including training of writers.


Mentor medical writers and other members of the project team who contribute to report preparation.

Job Requirements:

Education:

A minimum of a bachelor's degree in a health- or scientific-related related field with 2-3 years relevant management experience and +5 years experience in medical/technical writing within the pharmaceutical or biotechnology industry. M.S. M.A. MPH, PharmD, or Ph.D is preferred.



Work Experience and Skills:


Excellent verbal and written communication skills, interpersonal skills, team skills, and presentation skills.


Understanding of the drug development process required.


Familiarity with regulatory clinical trial reporting guidelines, particularly ICH E3, required.


Strong management and independent work skills.


Medical writing experience in the preparation of Phase I through Phase IV clinical study reports and in the summarization and reporting of efficacy and safety data for regulatory filings (NDA/CTD).


Experience in the analysis, summarization, and interpretation of scientific data and an ability to communicate clinical data succinctly, clearly, and accurately in writing.