Meet Recruitment is partnered with a well-established Biopharmaceutical company who has been a global competitor in the industry for well over a century. This company is rapidly growing, and currently expanding their exciting pipeline of both specialty branded and generics products.
This client is now seeking a talented medical writer to join their team at the Associate Director level, and ideally someone who can make a weekly onsite commitment to their Central New Jersey office location. This individual will be heavily responsible for all clinical and regulatory document development and delivery, as well as the oversight and management of outsourced contract & vendor writers.
• Plan, write, edit, and review clinically focused regulatory documents including but not limited to: briefing documents, eCTD Module 2 clinical-focused documents, Module 5 integrated summaries, pediatric study plans, and Health Authority responses
• Collaborate with document authoring teams to establish document key messages, timelines, and priorities
• Develop processes and SOPs for Regulatory Writing
• Provide input into resource forecasting for projects; establish vendor requirements for regulatory writing needs, and oversees vendors as needed
• Minimum of a Bachelor’s degree with regulatory or medical writing experience in the pharmaceutical/ biotechnology/ medical device industry
• Minimum of 7 years of drug/biologics development experience with a minimum of 5 years’ experience in the development of regulatory documents
• Experience leading teams, fostering cross-functional collaboration, and managing complex projects with multiple inputs
Full job description and company details are available upon application. This position is being dealt with by Meghan McCann at Meet Recruitment, call on +1 646-810-6063 or email directly at firstname.lastname@example.org to discuss further and in confidence.
You can find out more about Meghan & Meet at www.peoplewithchemistry.com