Shire R&D QA & Compliance Communication and Training Lead in Lexington, Massachusetts
Communications & Training
Successfully design communication strategies and tactics which promote and educate employees on R&D QA&C programs, organizational needs, regulatory standards, and other related business needs.
Develop, implement, and evaluate the R&D QA&C annual communications plan
Lead the generation of online content that engages various audience segments
Put communications vehicles in place to create momentum and awareness as well as to test the effectiveness of communications activities
Manage the development, distribution, and maintenance all communication material
Mentor and provide best business practices related to communication to R&D functions
Leverage the various Shire communication platforms
Leading stakeholder and cross functional needs, tasks, processes, and/or audience analysis sessions
Support the training team in the development of learning materials and curricula
Process & Standards
Ability to deliver consistent and standardized outcomes that aligns with the R&D QA&C personnel qualification strategy by:
Assisting in developing and implementing the R&D QA&C personnel qualification, performance support and communication strategy and platform;
Collaborating with the R&D QA&C Training team to create comprehensive training, performance support and communication design documents and curricula plans;
Performing quality checks to ensure personnel training requirements are in alignment with the R&D QA&C personnel qualification
Working in partnership with R&D QA&C, other R&D functional/training teams, and SMEs to identify needs and implement programs/initiatives by:
Collaborating on communication approaches, templates, program design and integration with the R&D QA&C training initiatives;
Being accountable for the success of the R&D QA&C program by helping and assisting others implement and align to the R&D QA&C personnel qualification, performance support and communication strategy
Key Skills, Abilities and Competencies
Strong writing skills
Knowledge of communication strategies and tactics;
Experienced at leveraging technology and content design to deliver “just in time” communications in new ways;
Capable of message simplification and strong writing skills;
Familiar with and/or awareness of applicable regulations and guidance governing our business i.e. GxPs, FDA, EMA, MHRA, ICH Guidelines and European Clinical Trials Directive;
Strong project management and decision making skills;
Excellent communicator and collaborator;
Process and compliant mindset;
Strong knowledge of evaluation principles and techniques;
Detail-oriented and task-driven when appropriate, yet also strategic, open and excited by change and re-invention;
Strong interpersonal, client consultation and problem-solving skills;
Proactive – sees trends and best practices to get ahead of issues;
Strong computer skills in PowerPoint and Word. Can work in SharePoint and other online software.
Education and Experience
Bachelor’s degree required;
At least 4 – 10 years of communication and/or instructional design experience
At least 3-6 years of pharmaceutical experience;
Track record in designing successful communication programs
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.