Mid-Size Pharmaceutical Company
Responsibilities will include, but are not limited to, the following:
Working with other relevant line functions, prepare phase 1 - IV clinical and regulatory documents and submissions, including Investigator Brochures, clinical study reports, integrated summaries of efficacy and safety, registration dossiers, package inserts, and responses to health authorities.
Participate in study and clinical team meetings and assist the teams in resolving issues related to document preparation.
Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
Prepare internal guidelines for document preparation.
Prepare templates for clinical documents that are consistent with FDA and ICH guidelines and with electronic submission guidelines.
Develop the strategy for document preparation, including time frames that meet or exceed company standards and the document review processes.
Facilitate document review meetings and discussions.
Participate in the development of outsourcing plans for medical writing
Manage outsourced medical writing projects
Review work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and stylistic requirements.
Train and guide other writers (in-house or contract) in company policies and procedures related to document preparation.
Assist with preparation of presentations for major external meetings.
Assist with transferring and presenting clinical / regulatory data to Marketing for journal submissions
Extensive experience writing all types of clinical & regulatory documents and with registration dossiers for worldwide use
Knowledgeable in preclinical development including discovery, toxicology etc.
Knowledge of FDA and ICH guidelines
Knowledgeable in industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD)
Ability to work with complex projects and within cross-functional teams
Experience working with CROs
Expertise in multiple therapeutic areas
Excellent grammatical and communication skills, both written and oral
Expertise in MS WORD, including the ability to solve technical problems with WORD templates
Previous leadership or supervisory experience
BS/BA degree in Biomedical Science (Ph.d preferred)
With 5+ years in the pharmaceutical industry or in a CRO
Iincluding 3+ years' writing experience