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About our client
Our client has pioneered a company focused on meeting the growing demand for credible evidence as it believes that this evidence can make a difference when trying to bring a drug to market and that it can enhance healthcare by defining patient requirements, clarifying therapeutic options, and providing patients with appropriate access to the medicines that they need. The company’s comprehensive services cover early-stage product planning through post-approval development. Its depth of industry expertise and a unique operational capability enables the company to demonstrate clinical benefit, manage safety, and minimize risk. The company helps document the economic value of medicines, and develop the evidence that is necessary to secure appropriate coverage and reimbursement.
Position	Location
Associate Director/Director, Medical Regulatory Writing	Pennsylvania
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Supervise preparation of clinical protocols, clinical trial reports, IND, NDA, CTD summary documents, and manuscripts for publication 2) Participate on recently acquired company’s and client project teams for project planning and development of timelines 3) Coordinate/consult with recently acquired company's clinical data services (data management, programming, biostatistics) and quality assurance on medical writing projects 4) Develop proposals and cost estimates for medical writing contracts
Requirements
1) Bachelor’s degree in Biological Sciences or equivalent 2) 9+ years' experience in medical regulatory writing in pharmaceutical/ biotechnology industry or clinical research organization 3) 3 years' experience supervising medical writers 4) Experience with oncology products a plus 5) Expertise in word processing 6) Familiarity with document management software, authoring, and publishing tools 7) Strong organizational and prioritization skills 8) Excellent communication and interpersonal skills