Job Description

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 experience 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 was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Roles & Responsibilities

• Confidently displays excellent internal and external customer service
• Responsible for implementation and execution of high quality medical writing
• Substantive knowledge of ICH guidelines, as applicable to medical writing
• Creates and presents medical writing training exercises, trains new medical writers, and serves as mentor
• Trains via self-study and self-practice independently and explores advanced topics related to MW and/or drug development
• Interacts directly and independently with client to coordinate all facets of projects; expert communicator who has developed strong relationships with clients
• Develops data and medical writing specifications jointly with other leads and managers
• Designs specific data presentations including creative summary tables, graphs, and patient listings
• Independently implements and validates QC findings in compliance with NC Handling Procedure
• Conducts thorough self-review of deliverables prior to releasing to client; serves as expert reviewer for others
• Follows processes related to project management as appropriate for medical writing projects (e.g. updating Mdoc, updating PSS, PWA etc)
• Demonstrates extensive knowledge of departmental processes
• Demonstrates complete proficiency in client interactions
• Takes initiative to suggest and implement medical writing improvements and follows through to completion
• Leads projects, delegates tasks, and manages timelines, resources, budgets, clients, internal team, and deliverables independent of management
• Demonstrates excellent internal and external leadership skills for projects
• Fully accountable for providing highest quality deliverables to satisfy or exceed client requirements
• Functions as a highly technical resource to the organization
• Produces and presents external company presentations providing industry visibility for the organization
• Builds and maintains strong client contacts and relationships
• Continually suggesting solutions to solve issues in tune with organizational direction
• Complies with Document Control Procedure
• Complies with Record Control Procedure

• Post graduate in Life science or related field, or related experience
• Experience of minimum 10 years in the medical writing field or CRO industry
• Expertise in drug development as it pertains to medical writing; has the ability to apply drug development knowledge during production of high quality writing projects or QC projects
• Extensive hands-on experience with clinical trials and pharmaceutical development
• Excellent medical writing and logic skills
• Extensive experience in pharmaceutical or CRO industry
• Thorough and extensive knowledge of clinical database structures
• Strong capabilities in medical writing data presentations
• Subject matter expert in medical writing skills; willing to guide others in a variety of medical writing techniques
• Expert proficiency with MS Office applications
• Excellent organizational and communication skills
• Strong familiarity with ISO 9001:2015 requirements

MMS Holdings Inc.