Associate Director/Director - Medical Writing - GROWING COMPANY!

Associate Director/ Director - Medical Writing - GROWING COMPANY!

 

We have a great client, located in Bucks County, PA, that is growing at a very rapid pace.  If you are looking for an organization that has the potential to double in size within the next 1-2 years, while still maintaining a relaxed, casual, family-oriented type of environment, then look no further.  Why work for a huge company and become a "number" when you can become part of a "family."  Due to recent growth, my client is currently seeking someone to oversee their Medical Writing department - a group of approximately 6 people - and expanding!  This person will not only contribue as a Sr. Medical Writer themselves, but will also have the ability to supervise the Medical Regulatory personnel, while also managing the medical writing projects in general. 

 

Responsibilities will include: 

 

? Supervise preparation of clinical protocols, clinical trial reports, IND, NDA and CTD summary documents, and manuscripts for publication

? Participation on client project teams for project planning and development of timelines

? Coordination/consultation with clinical data services (Data Management, Programming, Biostatistics) and Quality Assurance on Medical Writing projects

? Development of proposals and cost estimates for Medical Writing contracts

 

Qualifications should include, but not be limited to:

? Bachelor?s degree in biological sciences or equivalent

? At least 9+ years experience in medical regulatory writing in pharmaceutical or biotechnology industry or clinical research organization; experience with oncology products highly desired

? At least 1-3 years experience supervising medical writers

? Expertise in word processing; familiarity with document management software, authoring and publishing tools

? Strong organization and prioritization skills