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Manager, CMC/ Nonclinical Writing

Location: Edinburgh
Company: MMS Holdings Inc.
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MM S is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency, 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 (https://www.linkedin.com/company/mms-holdings-inc-/) .
Roles & Responsibilities:
- Maintains a strong understanding of regulations and guidance as they pertain to CMC and/or nonclinical writing; mentors others; advises on MMS updates related to regulatory updates
- Understands styles of writing for various document types, including more complex document types and mentors others; is the document subject matter expert (SME)
- Experience with CMC and /or Nonclinical documents required
- Proficient with Medical Writing (MW) tools, training, and processes; provides mentorship to others; is the SME
- Proficient in understanding impact of updates in related deliverables and mentors others
- Proficient with managing client meetings and CRMs and provides mentorship to others
- Proficient with managing a project from start to finish and provides mentorship to others
- Proficient with identifying and mitigating project risk and provides mentorship to others
- Proficient with understanding client gaps as opportunities, and appropriate follow up and mentors others
- Proficient with handling client feedback with appropriate feedback and provides mentorship to others
- 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
- Demonstrate strong understanding of ICH guidelines, as applicable to medical writing
- Create medical training exercises, train new medical writers, and serve as a mentor
- 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:
- Graduate degree in scientific discipline or relevant work experience
- Minimum of 5 years' experience in Scientific, CMC or Nonclinical Writing (in a CRO or Pharma environment preferred)
- Familiarity with ISO 9001:2015 and ISO 27001:2013 standards preferred
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements
- Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process
- Strong understanding of clinical trial development and data
- Excellent scientific writing skills; willing to guide others in a variety of medical writing techniques
- Proficiency with MS Office applications
- Ability to anticipate and effectively resolve potential problems and client demands
- Excellent organizational and communication skills
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