Grifols Shared Services North America, Inc Associate Director, Medical Writing in Durham, North Carolina
Manages the medical writing group that supports globally the Grifols Clinical Operations staff both in Spain and the USA. Requires an understanding of status of all medical writing projects both current and pending in order to be able to manage workload and distribution across resources. Oversee’s training, medical writing standards and operating procedures and tools for best practices. Oversees quality control across all documents produced by medical writing and for other documents produced by the clinical operations teams. Manages worldwide registration and results disclosure of clinical studies as required by Food and Drug Agency (FDA) and the European Union Drug Regulating Authorities Trials Database (EudraCT). Writes and functions as a Senior Medical Writer to produce documents such as protocols, clinical study reports, submission dossiers, investigator brochures.
● Supervises, manages, and provides training for medical writers (internal and external staff)
● Understands status of all medical writing projects both current and pending in order to manage workload and project resourcing needs. Able to adjust work assignments based on any changing priorities from the business.
●Reports on project status to management.
● Engages and supervises any contractor/contract research organization (s) (CRO) that may be required to support medical writing in document preparation, web registration and results disclosures or Quality Control and is accountable for their performance.
● Prepares annual budgets and tracks spend for external CROs against budget.
● Documents Quality Control (QC) program for both clinical regulatory submission documents and scientific publications.
● Manages Grifols Policy Standards for Disclosure of Grifols Clinical Trial and Results Information. Sets up and manages a system to meet FDA US, European, and global regulations requiring clinical trial registrations and study results disclosure.
● Oversees and supports processes with QA for creation of new or revision/update of existing SOPs relevant to medical writing that will support FDA or European and other global regulatory requirements for document submissions. Works with team to ensure tools available for best practices (templates, writing guides etc).
● Works with QA to respond to any audit findings on internal/external CRO audits to ensure regulations for Grifols SOPs up to date and best practices adopted.
●Implements electronic filing system for Medical Writing Team for Key documents and ensures process in place to move required documentation to the respective Trial Master File for a given Clinical Study Program.
●Tracks timeline requirements for Investigator Brochure updates and ensures all parties that need to participate in updates have been given advance notice.
●Assigns medical writers and or participates in some Clinical Project Team meetings to understand any ongoing needs of the department for medical writing.
● Writes and functions as a Senior Medical Writer to produce documents such as protocols, clinical study reports, submission dossiers, investigator brochures. Authors first and subsequent drafts of documents and obtains review and approvals from team and upper management.
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.
●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 regulators
● Organizes the material with co-authors, formats, and co-ordinates processes for internal review and prepares the document for final sign off. Ensures that the production of key document is according to departmental SOPs.
●Interacts with and provides editorial assistance to physicians and key opinion leaders that may be involved in preparing documents.
● Authors first drafts of documents or abstracts/posters from clinical study data or other sources, such as drug safety or published sources.
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, plan work flow, and communication skills to interact with medical writing group, clinical teams, management and other parties both internal and external.
Advanced degree: Master’s, PhD, or PharmD preferred.
Requires 8 Years Experience at Bachelors degree. Equivalent of 6 years for a Master's or PharmD. Equivalent of 4 years experience for a PhD. Experience consists 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. (If Bachelors degree, equivalency is 8 years direct experience in medical writing and supervisory experience required)
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 and stands. 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 information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Req ID: 209667