at Certara USA, LLC in Wilmington, Delaware, United States
The Senior Medical Writer (SMW) will support our clients by drafting medical publications with knowledge of publications processes and requirements. The SMW will be client facing and have the opportunity to work collaboratively across our team. SMWs will lead projects, write publications, collaborate with experts and mentor more junior colleagues.
Create documents for all phases of drug development, including manuscripts, abstracts, posters, oral presentations and slide sets through their lifecycle
Independently write first drafts with input from lead author from CSR and/or TFLs
Coordinate or complete journal/abstract submissions adhering to journal and congress requirements
Perform Project Management responsibilities including: managing specific details of a project, coordinating with the authors, scheduling and participating in meetings, showing excellent interpersonal skills and flexibility
Coordinate with lead author to prepare outlines and timelines
Manage and drive document reviews and address comments. Facilitate comment resolution discussions with internal client authors and external KOLs.
Obtain and retain required documentation for publication per client policies.
Understand and follow all client publication policies and procedures, including confidentiality, secure file transfer, copyright law and privacy protection
Education, Experience, Training, and Knowledge:
BS/BA degree in relevant field or equivalent experience required; PhD, MD or PharmD preferred
3+ years of experience as a professional medical writer who has contributed or written many medical publications, manuscripts, presentations, posters and letters across therapeutic areas
Advanced graphics capabilities to produce publication quality figures
Experience with developing social media summaries and video abstracts a plus
Knowledge of the regulatory industry in the US and abroad, remaining up to date with changes in different therapeutic areas
Skills & Abilities:
Proficient in MS Office Suite (MS Word, PowerPoint and Excel); Adobe Acrobat for developing and editing poster slides, pdf poster layouts and slide sets
Knowledge validating publication guidelines and specifications, client publication policies and procedures, confidentiality, secure file transfer, copyright and privacy protection.
Excellent oral and written communication skills to work across an organization, facilitate discussions with clients and client authors and key opinion leaders within an industry
Strong analytical skills to anticipate client needs within a client engagements, identify where improvements can be made and offer suggestions for making work more efficient
Maintain industry knowledge, identify and adopt work practices that are the most effective to ensure consistency in performance for self and the team
Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. The well-being of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:
Financial - competitive pay, incentives, retirement plans, income security programs
Health and Wellness - comprehensive benefit package, wellness programs, healthy lifestyle office environments
Work/Life - unlimited paid time off and an employee assistance program
Growth & Development - performance driven environment
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.