Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
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We are looking for a full-time employee, remotely based within the UK.
Job Specific Skills:
Maintains a strong in-depth knowledge of applicable regulations and ICH guidances as well as regional specific guidelines where they exist.
Expertise with MS Office, Adobe Acrobat and SharePoint applications, SAS viewer and eCTD viewer.
Expertise tracking, reporting of central submission/approval progress, and archiving of all regulatory activity in applicable MMS systems.
Provides strategic input and technical guidance on regulatory requirements to project teams including oversight for the publishing of regulatory submissions according to ICH guidance and monitors the impact of changing regulations on submission strategies and updates, participating in implementation as applicable; Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
Reviews, develops, gives advice on, and/or writes regulatory documents, meeting requests and regulatory responses for Scientific Advice, CTAs, and/or MAA. Serve as the lead strategist for the original marketing application; Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs).
Understands the eCTD submission process and how to work with Reg Ops and can answer questions for internal and external stakeholders with regard to the eCTD submission process; Also, understands regional submission variation for marketing applications.
Knowledge and advisement of expedited approval applications, orphan drug designation, meeting requests, and briefing docs and regulatory responses.
Acts as POC for regulatory submissions and ex-US Competent Authorities and coordinates across multiple regions for investigative and marketing applications.
Manages regional label negotiation activities.
Advises on annual reports and coordinates multiple annual reports; also should have experience with post-approval safety updates.
Advises on harmonization of US and Global submissions (e.g., VHP, coordinated IND and IMPD writing, management of IB and Protocol amendments across regions, etc.); determines optimal regional submission strategy for marketing applications.
Coordinates with clinical CROs, local Authorized Agents and third party vendors on global regulatory submissions (overarching PM, managing versioning, coordinating responses to queries and information requests).
Can optimize a clinical trial submission or marketing application submission strategy based on regional knowledge.
Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
Project Management: Follows processes related to project management as appropriate for medical writing projects (e.g. close-out procedures etc.)
Manages project risks and timeline.
Effectively manages multiple projects and delegates as needed to complete…