Submission Medical Writers – Director and Manager/Senior Manager levels
Pfizer’s Clinical Science Medical Writing group provides end-to-end medical writing support engaged in the early design, protocol authoring, development of key messages, shepherding the storyboard as a dynamic document, analysing data and proceeding through study and submission reporting and beyond. The group provides authoring expertise across a broad range of therapeutic areas including Pfizer Consumer Healthcare, Anti-infectives, Vaccines, Cardiovascular, Metabolic Diseases, Rare Diseases, Inflammation and Immunology, Neuroscience, Pain and Oncology.
As a Submission Medical Writer, you will create documents relating to clinical data and post-marketing safety data to support product development, license application and post-marketing maintenance. These will include briefing documents to support meetings with regulatory agencies, clinical documents for marketing authorisation applications and responses to clinical and safety questions from regulatory authorities. You will also work in collaboration with project teams, providing expertise and strategic guidance on regulatory requirements and the presentation of clinical and safety data.
We have two opportunities: one at Manager/Senior Manager level and one at Director level. Both call for a master’s degree or PhD (preferably in life sciences), or a bachelor’s degree in a life sciences field and pharmaceutical industry experience, ideally in the safety, regulatory or clinical areas. Excellent communication, analytical and writing skills are also essential.
For the Manager/Senior Manager role, you should bring the ability to interpret analyses of data supporting regulatory documents, as well as an understanding of relevant regulatory guidance. In addition, you are able to synthesize analyses of aggregate or individual patient data into clearly written text.
For the Director level role, you will have the ability to act as an authority on the interpretation of regulatory guidance and its significance in a broad range of situations. Experience of interpreting complex analyses of data supporting regulatory submissions is also important, along with expertise in synthesizing analyses of integrated patient data from single pivotal and multiple studies into clearly written text.
How to apply
Please apply online at www.pfizercareers.com and search for job ID number 1052486 for the Director level and 1602201 for Manager/Senior Manager level.Closing date: 22nd October 2017 2017.