Product Features
Blog
Contact Us
Sign In
Certara
,
London, Greater London
Senior Medical Writer - UK Locations
Overview
Job Description
Certara company overview: Certara is the global leader in advancing modern, efficient drug development. We provide proven modeling & simulation, regulatory and real-world value assessment software platforms and services. In partnership with our clients, we help reduce clinical trial burden, accelerate regulatory approval and increase patient access to medicines. Synchrogenix, A Certara Company overview: Achieving Regulatory Success As Certara's Regulatory Science division, Synchrogenix accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Synchrogenix is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are talented, quality-minded, and client and stakeholder-oriented. Synchrogenix's people are at the core of our success, and our most successful people are: * collaborative and value being part of a team * experts with a thirst for continued learning * consultative with an ability to articulate process and expertise * deadline-driven and able to operate in a fast-paced environment Job Overview: The Senior Medical Writer will support our clients by drafting medical publications. SMW will be client facing and have the opportunity to work collaboratively across our team. Leading projects, authoring publications, partnering with experts and mentoring more junior colleagues are all responsibilities of the SMW. Responsibilities: * 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 * 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 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 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.