Senior Medical Writer


Published
March 27, 2019
Location
Bethesda, Maryland
Job Type
Job Level
Other

Description

Position Overview:
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.
Principal Duties and Responsibilities (Essential Functions**):
  • 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.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.
  • Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Represents the department as a prime contact on projects including 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, Professional Skills & 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
  • 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.
  • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
Personal Skills & Competencies 
  • Aptitude to accurately work with, manipulate and format numbers, numerical information, and data of various types to provide evidence, information, and insights
  • Demonstrated ability to communicate and document information effectively in written English, including the ability to produce reports, documents, emails and other written pieces which are well-organized, free from errors, and are appropriately adjusted to the characteristics and needs of the audience
  • Able to analyze complex issues and evidence, identify cause-effect relationships, and generate effective solutions.
  • Able to create, communicate, and manage effective project plans that support the delivery of overall project objective(s); to identify, manage and guide project team members; to monitor and report on progress in an organized fashion; and to deliver the required results.
  • Demonstrates sound professional judgment in analyzing, responding to, and resolving enquiries, issues and escalations.
  • Able to facilitate the resolution of conflict among team members and clients, through listening and understanding the cause(s), gaining agreement on an appropriate course of action, and following up to ensure a successful outcome.
Company Summary
Evidera is a global research consulting group that partners with life sciences organizations worldwide to develop, capture, and communicate the clinical and economic evidence required to substantiate the value of their products and optimize their products’ market access and commercial success.  Our research and consulting services are driven by world-class science and thought leadership and leverage a unique combination of capabilities in health economics, outcomes research, market access, data analytics, and epidemiology.
 
Perks
Evidera offers a competitive salary and benefits package, with clear opportunities for growth and career progression. You will have the opportunity to work on multiple projects with some of the industry’s leading researchers. Our offices boast a fun and collaborative working environment, frequent social events and a robust support system. We are committed to providing training and professional development, with ample opportunity to advance, for all our staff.
How to Apply
Please complete your online profile by attaching your CV and covering letter addressing your suitability for the role.
Evidera, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, sexual orientation, gender preference, disability, or status as a qualified individual with a disability or protected veteran.
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