Principal Medical Writer

About the role

Principal Medical Writer ICON plc is a world-leading healthcare intelligence and clinical research organization. We are committed to supporting the development of innovative treatments for diseases with high unmet needs and ensuring timely, accurate communication of scientific information to key stakeholders.

Purpose of the Role

ICON is committed to supporting the development of innovative treatments for diseases with high unmet needs and ensuring timely, accurate communication of scientific information to key stakeholders.

Roles and Responsibilities

- Lead development of scientifically accurate, balanced slide decks and medical content for field medical teams based on strategic priorities and stakeholder needs, leveraging cross-functional expertise. - Ensure all medical materials are scientifically accurate, relevant, and aligned with published literature, internal scientific data, and company standards. - Develop project timelines and ensure timely delivery of resources while effectively communicating status updates to stakeholders. - Support localization of materials for the US affiliate, ensuring alignment with local labeling requirements. - Manage materials through medical, legal, and regulatory review processes. - Incorporate stakeholder insights into content development and ensure alignment with overall medical strategy. - Maintain broad knowledge of therapeutic areas, product labeling, and regulatory guidance. - Serve as a Medical Affairs liaison to cross-functional teams, integrating current scientific and medical information into departmental materials and processes. - Manage vendor relationships and oversee outsourced content development activities.

Skills and Competencies

- Ability to build strong partnerships with internal and external stakeholders and work effectively across functions. - Strong operational skills, attention to detail, and commitment to established processes. - Demonstrated project management experience. - Commitment to providing exceptional customer service and supporting business objectives. - Excellent written, verbal, and presentation communication skills. - Ability to work independently and collaboratively within a team environment. - Proven track record of delivering results that meet or exceed objectives. - Strong understanding of industry regulations and Medical Affairs best practices.

Education, Experience, and Qualifications

- Advanced degree (MD, PhD, PharmD, or equivalent) in a scientific discipline. - 3+ years of industry experience, preferably within Medical Affairs. - Experience managing vendors and external content development partners. - Experience with componentized content creation preferred. - Experience with content management systems such as Veeva Vault preferred. - Significant pharmaceutical or biomedical writing and communication experience, including facilitating discussions and presenting to diverse audiences.