R&A Associate Principal Medical Writer

Certara

16d

About The Position

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization. Job Overview: The Associate Principal Medical Writer (APMW) will support clients by drafting medical publications with knowledge of publications processes and requirements. The APMW will be client facing and work collaboratively with the Medical Publications and Communications team and across Certara. APMWs will lead projects, write publications, collaborate with experts, and mentor more junior colleagues.

Requirements

PhD, MD, or PharmD, or equivalent experience required
7+ years of experience as a professional medical writer who has written 25+ primary and secondary manuscripts, 25+ abstracts, and 25+ posters or oral presentations across all phases of drug development and a variety of therapeutic areas; expertise in chronic, inflammatory dermatology, rheumatology, and gastroenterology diseases a plus
Expert knowledge of drug development and pharmaceutical product life cycle in the US and abroad, Good Publication Practices, ICMJE guidelines, and CONSORT and other major scientific reporting guidelines
Proficient in MS Office Suite (MS Word, PowerPoint, and Excel) and Adobe Acrobat
Excellent oral and written communication skills
Strong interpersonal and critical thinking skills to anticipate client needs within client engagements
Analytical skills and ability to understand and summarize a variety of data, including preclinical, clinical (phase 1-4), pharmacokinetic (PK), and pharmacodynamic data, experience with population PK and modeling data a plus

Nice To Haves

Advanced graphics capabilities to produce publication-quality figures a plus
Experience with developing graphical abstracts and lay summaries
Experience conducting quality control reviews for medical publications a plus

Responsibilities

Create medical and scientific publication documents for all phases of drug development, including manuscripts, abstracts, posters, oral presentations, and slide sets from outline through submission
Review data and lead kick-off meetings 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 detailed outlines/first drafts with input from core publication team for both primary and secondary abstracts, posters, or manuscripts from statistical data output
Manage and drive draft reviews, document and address all reviewer comments, and schedule and facilitate comment resolution discussions with core publication team as necessary
Coordinate or complete journal/congress submissions adhering to client and venue requirements
Perform Project Management responsibilities including logging of hours and documentation of milestone deliveries
Obtain and retain required documentation for publication per client and venue policies
Understand and follow all industry, company, and client publication policies and procedures, including confidentiality, secure file transfer, copyright law, and privacy protection
Maintain industry knowledge and identify and adopt effective work practices to ensure efficiency and consistency in personal and team performance