About Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries
Job Overview:
The Principal Medical Writer (PMW) will support our clients by drafting medical publications with knowledge of publications processes and requirements. The PMW will be client facing and have the opportunity to work collaboratively across our team. PMWs will lead projects, write publications, collaborate with experts and mentor more junior colleagues.
Responsibilities
Responsibilities:
- Create medical and scientific publication documents for all phases of drug development, including manuscripts, abstracts, posters, oral presentations and slide sets through their lifecycle
- Review data and prepare high level outline with input from client lead author
- Lead kick-off meeting with authoring team to align on target venue, author byline, key concepts, timeline, and authorship responsibilities
- Provide publication strategic and tactical planning and execution guidance and consulting
- Independently write first drafts with input from lead author for both primary and secondary manuscripts from statistical data output to address specific unmet medical questions
- 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
- 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 adhering to Good Publication Practices (GPP3), ICMJE guidelines and other industry standards.
Qualifications
Education, Experience, Training, and Knowledge:
- PhD, MD or PharmD, or equivalent experience required
- 7+ years of experience as a professional medical writer who has written many primary and secondary manuscripts, abstracts, posters, and oral presentations across all phases of drug development and therapeutic areas, particularly with expertise in auto-immune diseases specific to dermatology, rheumatology, and gastroenterology diseases
- Advanced graphics capabilities to produce publication quality figures a plus
- Experience with developing lay summaries and video abstracts a plus
- Knowledge of drug development and pharmaceutical product life cycle in the US and abroad, remaining up to date with changes in Good Publication Practices (GPP3) and other Industry standards
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 publication guidelines and industry standards, adherence to 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 internal and external authors
- Strong analytical skills to anticipate client needs within 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
OTHER INFORMATION:
Number of Employees Supervised: none
Percentage of Travel Required: 0%
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.