- Opportunity to work collaboratively across a Global team
- · Offers career growth and competitive compensation and benefits
Promotes Work-Life balance
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 the 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 the 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
- Experienced 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 is 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 engagement, 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 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, gender, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
At Certara, we accelerate medicines to patients by partnering with life science innovators.
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:
- informed decision-making & reduced clinical trial burden
- higher R&D productivity
- improved patient outcomes & increased patient access to medicines
- accelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.