Job Information
MMS Holdings Inc. Senior Drug Safety Writer in Canton, Michigan
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 (https://www.linkedin.com/company/mms-holdings-inc-/) .
Roles and Responsibilities
Responsible for writing safety documents intended for submission to regulatory agencies.
Responsible for writing patient CSR narratives and producing high quality documents
Practices excellent internal and external customer service
Good understanding of MS Word for advanced writing techniques
Address client comments during document lifecycle, manage revisions, and review deliverables with limited mentor oversight prior to releasing to client
Ensure documents comply with appropriate ICH and regulatory guidelines
Interact directly and independently with client
Ability to follow MMS and sponsor processes
Practices internal and external leadership skills
Requirements
Experience in aggregate reports (DSURs, PBRER/PSUR) and RMPs
College graduate in scientific, medical, clinical discipline or related field, or related experience
Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing
Master?s or PhD in a scientific, medical, or clinical discipline preferred
1-3 years? experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment
Understands ICH guidelines, as applicable to medical writing for clinical studies
Excellent written English skills
High degree of organization and able to manage multiple projects at any given time
Attention to detail and committed to excellence in all aspects of their work
Excellent communication and interpersonal skills
Proficient in Microsoft Word and Adobe Acrobat
Experience in the use of an Electronic Document Management system