Grifols Shared Services North America, Inc Associate Director, Medical Writing in RTP, North Carolina
Associate Director, Medical Writing
Manages the medical writing group workload, resources, budget planning, and personnel. Oversees non-writing functions assigned to the medical writers including, quality control of all documents and worldwide registration and results disclosure of clinical studies. Writes and functions as a medical writer. Leads various teams (both internal and external) involved in the clinical study or group generating the data to engage all parties who may contribute to writing sections of documents.
Responsibilities for the Role:
Supervise and Manage Medical Writers and other Staff.
Prepare annual budgets and allocate the group’s resources
Document Quality Control (QC) program for both clinical regulatory submission documents and scientific publications.
Manage GRIFOLS Disclosure of Clinical Trial and Results Information. Set up and Manage a system to meet FDA US, European and Global regulations requiring clinical trial regulations and study results disclosure.
Oversees and supports processes for review and approval of new or update of existing SOPs relevant to medical writing and quality.
Authors the first and subsequent drafts of clinical study reports from data generated from clinical studies. Authors first drafts of documents or abstracts/posters from clinical study data or other sources, such as drug safety or published sources.
Utilizes statistical and medical literature evaluation skills to compare data and potential citations for generation of these documents. Uses appropriate style, grammar, and flow and assumes responsibility for completeness, accuracy, and content of the prepared document.
Organizes the material with co-authors, formats, and co-ordinates processes for internal review and prepares the clinical report for final sign off. Ensures that the production of final report is according to departmental SOPs.
Supervises medical writing aspect of the contract research organization (CRO) and is accountable for their performance.
Provides authorship support to medical directors for protocol shells annual safety reports, updates the investigator brochures, and regulatory documents such as sections of Biological License Applications to FDA and other regulatory agencies.
Interacts with and provides editorial assistance to Physicians and key opinion leaders that may be involved in preparing documents.
Advanced scientific, technical and clinical studies knowledge. Advanced knowledge of MS Office, Viso, ISI Writer, Reference Manager, and medical/scientific search/retrieval tools. Advanced analytical, organizational, project management and communication (oral and written) skills. Ability to multi-task.
SALARY GRADE: E02
LOCATION: RTP (OFFICE) Not a REMOTE Position
PhD, MD, or PharmD degree, plus 5 years of high-level pharmaceutical experience in clinical research and regulatory document medical scientific writing. Project or technical leadership experience required. Supervisory or management experience preferred.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
Req ID: 123427