Associate Principal Scientist Medical Communications - 8235

Responsibilities:The Associate Principal MCS (APMCS) is a strategic regulatory medical writing role.The role focuses on leading the development of clinical documents for marketing authorization submissions (NDAs, BLAs, MAAs, JNDAs etc).The APMCS provides expert communications leadership to drug projects and drives strategic medical writing activities, ie, ensures the development of a coherent messaging strategy for a submission, aligns document content to that strategy, and leads efficient planning and authoring of the submission documents.The APMCS is a recognized expert in submission preparation and typically authors the most complex and critical documents (eg, Clinical Overviews). APMCSs also oversee internal or vendor medical writers who author other submission documents.They build strong partnerships with their internal drug project teams and with vendor medical writers to ensure delivery of submissions to time, cost and quality.The APMCS role is one that has moved on from writing study-level documents to authoring more complex documents and submissions, taking on more strategic responsibilities and leading global authoring teams.Person to sit on site in Gaithersburg, or Durham NC, or remote - with the ability ot travel to key meetings.Medical Communication Scientists (MCS) ensure that NDA/BLA/MAA/JNDA/CN/ROW clinical documents align with project strategies, meet regulatory requirements and adopt best communications practices. The group has a clear vision to expertly drive strategic communications excellence to achieve successful submissions and approvals.The Associate Principal MCS provides expert communications leadership to drug projects and drives strategic medical writing, advocating communications excellence and leads the efficient planning and authoring of clinical submissions. The role provides direct support and advice to teams as an expert or through oversight of internal or vendor staff. They are a recognized expert in the field and often the first point of contact for related queries. They prepare clinical regulatory documentation and provide support across programme and strategy level. They provide strong partnership with vendor medical writers to ensure delivery to time, cost and quality.The Associate Principal MCS role is one that has moved on from writing study-level documents to authoring more complex documents and submissions, taking on more strategic responsibilities and leading global authoring teams.Lead development of the clinical submission communication strategy for a new product, liaising with senior project staffProspectively develop a storyboard for the submission and identify how the proposed prescribing information will be supportedBuilding and delivering clinical-regulatory submissions and defence o Collaborate with the TA Head and MCS authoring team leader to develop resourcing strategiesLead a team of authors (internal and external) to deliver clinical contribution to a submissionEnsure alignment of clinical submission documents with the proposed prescribing informationAuthoring documents that facilitate efficient evaluation and approval by health authorities: o Author the most complex and important documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees)Driving continuous improvement and operational excellence from a communications leadership perspective: Develop and implement new best practices in communication and submission developmentTrain and develop less experienced Medical Communication Science staffExperienceBachelor's degree in the life sciences requiredMSc or PhD in the life sciences desiredMinimum of two years' experience within the pharmaceutical/medical industry/CROBroad working knowledge of the clinical drug development process with experience in integrating information from all phases of clinical development into clinical-regulatory documents/submissions.Comprehensive knowledge of current regulatory guidelines relating to regulatory communications.Excellent communication skills.Flexibility in adapting to changing circumstances or new information.Contribute to the development of the discipline internally and stay well informed about the external disciplineMay act as a global lead, authoring complex documents, coordinating authoring teams to deliver in line with project strategy, ensuring quality and efficiency in delivery, establishing communication standards and best practice within a project teamWillingness to undertake domestic and international travel as required by the project.