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Senior Medical Writer (AMER)
Ref No.: 17-00061
Location: Morrisville, North Carolina
Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. Provides technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Effectively manages medical writing projects to deliver quality products in agreed timelines. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Independently researches, writes, and edits clinical study reports, study
protocols and standard response documents. Produces complex clinical or
scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and
dossiers. Provides senior review of documents and training/mentoring for other
writers.
-Manages all aspects of planning, organizing, and executing projects without
supervision including: developing project timelines, standards, budgets,
forecasts, and contract modifications. Liaises with other functional units as
necessary (i.e., project management, clinical, QA, data management,
biostatistics, regulatory). Identifies and escalates out-of-scope project activities
in a timely manner and proposes solutions.
-May manage several long-term projects concurrently.
-Represents Medical Writing in Project Launch Meetings, Review meetings, client
audits, bid defenses, and capabilities presentations.
-Establishes and develops client relationships; independently initiates and leads
interactions with clients.
-Assists with business development and development of budgets and proposals.
Education and Experience:
Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational
qualification; Advanced degree preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
5+ years') or equivalent combination of education, training, & experience.
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Knowledge, Skills and Abilities:
-Excellent data interpretation and medical writing skills, including grammatical, editorial, and
proofreading skills
-Strong project management skills
-Excellent interpersonal skills including problem solving
-Strong negotiation skills
-Excellent oral and written communication skills with strong presentation skills
-Significant knowledge of global, regional, national and other document development guidelines
-In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions,
communications, etc.
-Great judgment and decision-making skills
-Excellent computer skills and skilled with client templates; Good knowledge of document
management systems and other relevant applications (e.g. Excel, Outlook)
Working Conditions and Environment:
• Work is performed in an office environment.
• Exposure to electrical office equipment.
Physical Requirements:
• Ability to work in an upright and /or stationary position 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.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop
computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.