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Manager, Regulatory & Medical Wri...

This listing was posted on The Resumator.

Manager, Regulatory & Medical Writing (South Africa)


About MMS Holdings MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry background 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 4 continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards.For more info, visit or follow MMS on LinkedIn. About the position: Manager I, Regulatory & Medical Writing We are recruiting for an experienced medical writing manager to take on a newly-created management position in our South Africa team. This is a pivotal role for the MMS SA Medical Writing Group and will involve the direct line management of a number of experienced and junior medical writers within the team, as well as working closely with the existing medical writing leadership group in the US, Europe and India. We are looking for a motivated self-starter with existing medical writing managerial background who is looking for a fresh challenge. This position is an office-based role out of our Bloemfontein location. Roles & Responsibilities: Provide leadership, mentor, and develop personnel by maintaining a positive workplace atmosphere Direct, manage and oversee the activities of direct reports; responsive to global needs 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 qualifications, 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 teammates and independent coordination with client Demonstrate excellent internal and external leadership skills for projects Job qualifications Previous line-management experience gained within the pharmaceutical or CRO industry University / College graduate in scientific, medical, clinical discipline or related position, or related experience Has high-level knowledge of drug development as it pertains to medical writing; has the expertise to apply drug development knowledge during production of high-quality documents Background in the pharmaceutical or CRO industry Expertise to anticipate and effectively resolve potential problems and client demands Excellent scientific written correspondence skills; willing to guide others in a variety of medical writing techniques Proficiency with Microsoft office suite Applications and Technological Literacy Excellent organizational and communication abilities Must be collaborative and comfortable embracing Global Thinking Effective communication, Critical Thinking and Problem-Solving skills Demonstrates Flexibility, Adaptability and strong Personal Accountability Familiarity with ISO 9001:2015 qualifications
MMS Holdings
April 16 on The Resumator
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