Associate Director/Director, Medical Regulatory Writing

BioCor is a benchmark Clinical Research Organization specializing in clinical data services and consulting to support Phase I ? IV programs from clinical plan design to defense of global regulatory submissions. We serve pharmaceutical, biotechnology, medical device and venture capital companies worldwide.

At BioCor, our people have and continue to be our most important asset. We recruit outstanding individuals, exceptional in their field, who thrive working in or leading a team but are independent thinkers. Although diverse in our backgrounds, we are all dedicated, highly skilled professionals who share a common passion for excellence. We derive tremendous satisfaction from working together and from being a part of a fun, energetic and productive company environment in the exciting field of clinical development. The company offers competitive salaries and a comprehensive benefits package.  BioCor does not offer relocation packages.

BioCor is a company where all individuals have the opportunity to thrive and succeed, regardless of their background, ethnicity, gender, religion, or sexual orientation. This makes BioCor an equal opportunity employer and a better place to work and express individual talents.

We are seeking a full time Associate Director/Director of Medical Regulatory Writing with at least 9+ years experience who would like to join a growing, vibrant company.

 

General Job Description:

Management of medical writing activities for Medical Writing projects; supervision of Medical Regulatory Writing personnel

 

Essential Duties and Responsibilities:Supervise preparation of clinical protocols, clinical trial reports, IND, NDA and CTD summary documents, and manuscripts for publicationParticipation on BioCor and client project teams for project planning and development of timelinesCoordination/consultation with BioCor clinical data services (Data Management, Programming, Biostatistics) and Quality Assurance on Medical Writing projectsDevelopment of proposals and cost estimates for Medical Writing contracts

 

Qualifications:Bachelor's degree in biological sciences or equivalentAt least 9+ years experience in medical regulatory writing in pharmaceutical or biotechnology industry or clinical research organization; experience with oncology products highly desiredAt least 3 years experience supervising medical writersExpertise in word processing; familiarity with document management software, authoring and publishing toolsStrong organization and prioritization skillsStrong communication and interpersonal skills