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Manager, Regulatory and Medical Writing (Homebased) - South Africa - Fichardt Park

MMS

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn . Manager, Regulatory and Medical Writing Roles and Responsibilities: Provide leadership, mentor, and develop personnel by maintaining a positive work environment Direct, manage and oversee the activities of direct reports Responsible for development of colleagues Provide training, feedback, direction and ensure quality of deliverable Suggest and implement process improvements Responsible for planning and resourcing for on-time delivery of project deliverables that meet quality objectives Interact with clients on matters relating to contractual requirements, deliverable changes, timelines, and document content Practice good internal and external customer service Responsible for scientific medical writing and producing high quality documents Demonstrate strong understanding of ICH guidelines, as applicable to medical writing Create medical training exercises, train new medical writers, and serve as a mentor Proficient with styles of writing for various document types Interact directly and independently with clients to coordinate all facets of projects; competent communicator Lead projects, including complex projects with multiple team members and independent coordination with client Demonstrate excellent internal and external leadership skills for projects Requirements: University graduate in scientific, medical, clinical discipline or related field, or related experience Has high level knowledge of drug development as it pertains to medical writing; has the ability to apply drug development knowledge during production of high quality documents Experience with management in the pharmaceutical or CRO industry Ability to anticipate and effectively resolve potential problems and client demands Excellent scientific writing skills; willing to guide others in a variety of medical writing techniques Proficiency with MS Office Applications Excellent organizational and communication skills Familiarity with ISO 9001:2008 requirements If you have not received a response within 14 days of your application, please consider your application unsuccessful. Powered by JazzHR Apply Now

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