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Clinical Trials, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
The Emmes Company, LLC ("Emmes") is searching for a Director, Medical Writing located in our Rockville, Maryland, or Frederick, Maryland office. Emmes provides flexibility for office location preference, dependent upon position.
The Director will be a strategic, hands-on medical writing expert with responsibility for leading and managing a team of writers and for preparing high-quality clinical regulatory documents. The Director will contribute both strategic and operational perspectives. The Director will make significant contributions to department initiatives and will collaborate with key functions across the organization.
Act as the medical writing expert for assigned drug projects, and lead the planning, development, and implementation of the content strategy of clinical submission documents (with input from appropriate expert functions)
Drive the design of clinical submission documents in support of the Clinical Development Plan for assigned drug projects including: validating individual study protocol design and evaluating key messages of the clinical study report and other clinical submission documents
Lead the development of the project-level data presentation strategy and messaging standards
Maintain current knowledge on all regulatory agency medical review guidelines and drug approval requirements for assigned projects
Supervise Medical Writers and Senior Medical Writers in developing expertise in managing, writing and submission of documents
Use scientific expertise to write, review, and edit science-based reports such as the clinical protocol, Investigator’ s Brochure, clinical study report, informed consent, risk/benefit analysis and integrated summary, IND sections, Briefing Documents, annual reports, and verbal presentations and abstracts
Partner with the regulatory team to prepare other documents, as needed, for submission to Health Authorities
Must meet ICH, GLPs, and GCPs guidelines, develop and update submission writing style guide and review eCTD templates, as appropriate
Ensure continuous awareness of the medical writing activities, plans, scope(s) of work and ways of working across the organization
Contribute to medical writing proposals, bid defenses and monitor all medical writing budgets
Advanced degree (MS, PharmD or doctorate in a scientific or medical field) with at least 10 years in medical writing experience in the pharmaceutical/biotech/CRO industry
Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English
Experience writing, editing, reviewing, and formatting clinical regulatory documents; prior IND/NDA/BLA/MAA submission experience using eCTD
Understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, research methodology, the regulatory environment including FDA/ICH guidelines, and principles of GXP/ICH/CTD, and other global standards
Expertise in conducting focused literature searches on PubMed, Google Scholar and/or other similar medical literature databases
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Strong emphasis on medical terminology and/or research methodology
Ability to work collaboratively and coordinate the efforts of team members to resolve comments, and produce a final high-quality document
Experience managing direct and indirect reports, including medical writing contractors
Ability to plan, manage, and optimize resources
Strong leadership and influencing skills
Independently motivated with good problem-solving skills allowing analysis, synthesis and compilation of data from a broad range of disciplines
Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines without compromising document quality
Ability to work in a fast-paced, cohesive, collaborative team-oriented work environment
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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
Telecommuting is allowed.
Internal Number: 2469
About The Emmes Company
Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.