Senior Medical Regulatory Writer

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know?

Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit [Register to View] .

The Senior Medical Regulatory Writer will be responsible for the preparation and coordination of clinical study protocols and clinical study reports (CSRs), and other documents as needed. Provide support for and participate in development of submission level documents under guidance of senior staff. Production of scientific publications and other documents (e.g., abstracts, posters, manuscripts, etc.). Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Oversees and coordinates activities of other writers on higher complexity narrative projects. Ensure timely delivery of high quality documents to internal customers and Sponsors. Provision and development of intra- and inter-departmental training. Works with the management team to provide guidance and mentoring to Medical Writers to ensure best working practices are maintained. Scientific presentations both internally within Fortrea and externally (e.g., conferences). Represents the company at scientific meetings and meetings with clients. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

What to Expect

• Write and coordinate the development of protocols, CSRs or other clinical documents including those of a more complex nature

• Provide support in development of submission level documents under guidance of senior staff

• Oversees management and coordination of complex narrative projects

• Produces scientific papers, abstracts and/or posters, and presentations.

• Responsible for all medical writing aspects of project development and coordination, adherence to timelines and budget

• To prioritize and plan workload to a high standard. Effectively manage multiple assignments in parallel

• Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines

• Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.

• Act as medical writing contact for major clients and partners

• Keep up to date with developments in Medical Writing

• In consultation with more experienced staff, show initiative and ability to deal with complex project situations

• Inform management of medical writing problems promptly and propose solutions

• Provide advice on Medical Writing issues to project team members (internal and external) and help to resolve problems

• Contribute to Medical Writing initiatives to develop and improve processes

• Mentor and provide guidance and training to other medical writing staff

• Provide peer review and input on deliverables prepared by colleagues

• Provides scientific leadership and support to colleagues in the data management and reporting team

• Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences

• Review Fortrea SOPs and associated documents

• Represent department in audits and inter-department working groups

• Comply with Fortrea internal processes and procedures

• Performs other duties as assigned by Management

Education / Qualifications

Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred

Experience

• Minimum 4 years medical writing experience including 2 years as medical writing project lead

• Excellent command of written and spoken English

• Excellent written and verbal communication skills

• In-depth knowledge of MS Word

• Excellent organizational and time management ability

• Detailed knowledge of ICH guidelines applicable to medical writing

• Good understanding of medical/scientific terminology and experience in data analysis and interpretation