Medical Writer Ii

2 weeks ago

Toronto, Canada Fortrea Full time

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.

The Medical Writer II (Sponsor dedicated) in Canada will serve as Lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed. Provides support to more experienced writers with the preparation of complex clinical documents. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Production of scientific publications and other documents (e.g., abstracts, posters, manuscripts, etc.). Oversees and coordinates other writers on CSR appendices compilation and narrative projects. Prepare and review patient safety narratives and CSR appendices. Ensure timely delivery of high-quality documents to internal customers and Sponsors. Works with the management team to provide training to Medical Writers to ensure best working practices are maintained. 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- Prepares protocols and CSRs, including interpretation of clinical data and statistical results as appropriate.- Work under guidance from colleagues to assist development of protocols, CSRs and other clinical documents on complex studies and programs.- Prepare and review patient safety narratives.- Leads project management and coordination of narrative projects.- Oversee and coordinate other writers on CSR appendices compilation.- Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.- Participate in 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.- Incorporates internal and/or external review comments on clinical documentation.- Prioritize and forward plan workload to a high standard; to advise Management of problems promptly.- Participate independently in internal and external client meetings. Lead meetings as appropriate.- Responsible for project coordination and adherence to project timelines and budget- Identify ways to improve the efficiency and quality of work processes.- Mentor Associate Medical Writers and Medical Writer I, as appropriate.- Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience.- Provide training to Medical Writers and other staff as appropriate.- Represent department in audits and inter-department working groups.- Comply with Fortrea internal processes and procedures.- Performs all other duties as needed or assigned.

Education / Qualifications- First degree in life sciences (or equivalent).- Fortrea may consider relevant and equivalent experience in lieu of educational requirements_.- Excellent command of written and spoken English.- Good written and verbal communications skills.- In-depth knowledge of MS Word.- Good organizational and time management ability.- Excellent interpersonal skills.- Knowledge of ICH guidelines applicable to medical writing.- Good understanding of medical/scientific terminology and experience in data analysis and interpretation.

Preferred Qualifications- Advanced degree (PhD or Masters)

Experience- Minimum 3 years medical writing experience, including 1 year as medical writing project lead.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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