Associate Principle Scientist Medical Communications

Gaithersburg, MD or Durham NC, or remoteContract Duration: 12-36 monthsRate: NegotiableSalary: NA, $1.00Responsibilities:Excellent employment opportunity for an Associate Principle Scientist Medical Communications in Gaithersburg, MD or Durham NC, or remote.Lead the development of clinical documents for marketing authorization submissions (NDAs, BLAs, MAAs, JNDAs etc).Provide expert communications leadership to drug projects and drives strategic medical writing activities, i.e., 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.Recognized expert in submission preparation and typically authors the most complex and critical documents (e.g., Clinical Overviews).Also oversee internal or vendor medical writers who author other submission documents.May 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 teamEnsure 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.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.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.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 defenseLead a team of authors (internal and external) to deliver clinical contribution to a submissionRepresent Medical Communication Science on the high-level, cross-functional submission teamAuthoring documents that facilitate efficient evaluation and approval by health authorities: Author the most complex and important documents (e.g., Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees)Train and develop less experienced Medical Communication Science staffExperience:Bachelor's degree in the life sciencesMSc 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.Consistent display of ability in project management, thinking (conceptual, analytical and integrative), influencing and team working.Willingness to undertake domestic and international travel as required by the project.