Analysis Group is seeking a senior medical writing professional who will function as a Senior Medical Communications Specialist to support development of market access documents that communicate unmet need as well as clinical and economic value for life sciences products. Examples include global value dossiers (GVDs), US formulary dossiers (Academy of Managed Care Pharmacy Format), and Health Technology Assessment (HTA) submissions. The successful candidate may also help with the preparation of advisory board materials, manuscript development and submissions to peer-reviewed journals, as well as the creation of abstracts, posters, and slide presentations for scientific conferences.
The Senior Medical Communications Specialist must be able to understand all areas of clinical and biomedical studies relevant to the life sciences industry, including study design (both interventional and observational), data analysis, and communication. In addition, the ideal candidate will also have demonstrated experience providing writing support for health economics and outcomes research (HEOR) studies. The position requires excellent writing skills, a working knowledge of statistics, and broad familiarity with compliance guidelines and best practices for scientific communication. The ideal candidate will be familiar with professional standards for conducting systematic and targeted reviews of the scientific literature, including standards for evidence grading and assessment.
Essential Primary Functions
- Produce strategic, high quality, and timely materials, including dossiers, literature reviews, reports, abstracts, manuscripts, and presentations
- Work unsupervised and smoothly as an integrated member of project teams with the ability to manage multiple projects simultaneously
- Assume primary responsibility for writing the burden of disease, product description, and clinical sections of dossiers, reports, as well as narrative communicating the value proposition to support a new product
- Support client calls, project management, business development, and mentor junior colleagues
Essential Secondary Functions
- Effectively edit, proofread and format all client deliverables as well as occasional internal documents
- Review, critique, and revise written summaries of analytical work prepared by consultant project teams
- Handle all aspects of submission and follow up with journal editors; manage publication projects to ensure that authors respect deadlines and respond to comments promptly and effectively
Additional Duties and Responsibilities
- Contribute to team meetings throughout the project life cycle to anticipate the final product and suggest avenues that will maximize the quality of the ultimate deliverable
- Contribute a reader's perspective and constructive criticism to analytical teams to optimize the quality of the written deliverable
- Participate in the development of standard approaches to manuscript writing and content development
- Seek to impart knowledge to those less experienced in areas of expertise. Act as a resource to colleagues to help them improve their writing and data presentation skills in the development of tables, graphs, and other material ultimately incorporated in client deliverables.
- Excellent technical writing abilities. Must be able to write clearly and concisely and have prior experience with narrative communicating clinical and economic value
- Ability to understand and synthesize large amounts of clinical, scientific, technical, and medical information in order to summarize the salient points against short deadlines
- Familiarity with professional standards for conducting literature reviews and data extraction, as well as evidence grading, and quality assessment
- Familiarity with professional publication practices, including GPP3 and ICMJE authorship criteria. CMPP designation and/or AMWA MWC/certificate(s) considered an asset.
- Familiarity with medical terminology, clinical trial design, and statistics. Knowledge of the pharmaceutical development and approval process such as the FDA, EMA, medical guidelines, etc.
- Extensive experience with standard MS Office Suite software, including Word, PowerPoint, and Excel (proficiency a plus). Advanced document design skills (e.g., style, page, and document design) preferred.
- Familiarity with reference manager software (EndNote, Reference Manager, Mendeley, Citavi, etc.). Must be able to produce fully referenced content and to adapt easily to new technologies and methodologies.
- Excellent time, project management, and teamwork skills. Must be able to prioritize and meet overlapping deadlines, take ownership of task schedules, and work well with multiple teams on separate projects.