6 months ago
My client is a well-established biotechnology company with an international presence. Focused in developing cancer treatments, they successfully launched products globally and have an expansive pipeline of candidates in all phases of drug development. Currently seeking an 'Senior Manager, Medical Writing' to prepare high quality medical writing deliverables that support the company's clinical programs. Offering an exceptional benefits package and the opportunity to work in an entrepreneurial environment.
· Develop and prepare documents to be submitted to the FDA and EMA including Protocols, Investigator Brochures, Clinical Study Reports, Briefing Documents, and clinical summary sections of CTDs
· Work cross-functionally with members of Clinical Development teams to maintain consistent messaging strategy
· Oversee medical writing deliverables completed by third party vendors
· Review statements in deliverables to ensure they are accurate and supported by appropriate data
· Establish and maintain Best Practices and SOPs
· 3+ years writing experience in academic, clinical, or industry setting
· Experience writing protocols, IBs, and CSRs, submissions experience (IND and NDA) preferred
· Demonstrated understanding of the clinical development process and the documents required in each phase
· Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
· Experience in oncology preferred
This is a great opportunity to take on greater responsibility and advance your career in an organization that values your opinion.