Shire Regenerative Medicine's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
The Manager, Medical Communications duties and responsibilities will include the following (Other duties may be assigned):
• Provide verbal and written clinical and technical responses to inquiries from the health care professionals, patients and internal customers as it relates to Shire RM products;
• Write and update standard and custom response documents and product profiles;
• Review clinical and scientific data in terms of potential impact to the business and stay abreast on emerging scientific literature and clinical trial data as it relates to Shire RM products and their disease states;
• Conduct literature reviews and provide written analysis of the impact to the business;
• Present publication topics under their area of responsibility to the Shire RM Publications Team and participate in discussions
• Plan, organize and set priorities and timelines for publications and track and report on publications in development
• Coordinate the development of scientific, technical and medical publications (journal articles, abstracts, and medical congress abstracts/posters)
• Manage work with outside publications agencies and oversee the development of the draft publication strategy, track progress and coordinate the review and approval of publications
• Work with internal and external authors, securing appropriate agreements and coordinating the development of content based on author input
• Review draft abstracts, posters, slides, and manuscripts for content
• Ensures development of publications is in compliance with Shire RM’s publications policy and procedures
• Oversee the development and revision of statements of clinical relevance for Shire RM products and related disease states
• Develop materials to support the Medical Science Liaison team; and
• Work with Marketing, Sales, Clinical, Compliance, Legal and Regulatory and provide medical/technical support of corporate initiatives
Education and Experience Requirements:
PharmD, PhD, or MD degree with a minimum of 5 years of biotechnology or industry experience.
At least 1-2 years’ experience in the field of medical information is preferred.
At least 1-2 years’ experience in publication planning is preferred.
Key Skills, Abilities, and Competencies:
• Demonstrated ability to accurately and effectively evaluate medical/scientific literature
• Strong medical writing and communication skills
• Understanding of the regulatory/compliance requirements as it pertains to Medical Information/Medical Affairs and publication activities
Complexity and Problem Solving:
The candidate will be required to use their regulatory/compliance knowledge as well as their clinical expertise to appropriately address medical information questions verbally and/or in writing. The candidate must understand how to cater the response dependent on the requestor’s background (eg. external customer, internal customer,).
Shire is an Equal Opportunity and Affirmative Action Employer
Shire plc (Shire) is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its...