Executive Director, Medical Writing

Role Summary

Executive Director, Medical Writing leads the medical writing function at Lantheus, collaborating with cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related documents within agreed timelines. The role oversees MW activities, ensures regulatory compliance (ICH, FDA), and shapes strategic medical communication plans. This position is primarily site-based and requires on-site presence three days per week.

Responsibilities

• Lead the MW function and provide necessary MW capabilities for Lantheus, including assessing need for additional medical and/or regulatory writing support
• Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts; oversee other MWs, as needed, to ensure high-quality MW deliverables
• Participates in scientific communication planning, including development of strategic medical communication plans
• Partners with the study biometrics team to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
• Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
• Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• Collaborate with clinicians, clinical scientists, biostatisticians, and pharmacokinetics to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
• Manages the document review process ensuring conflicting comments are appropriately addressed
• Completes documents according to agreed-upon timelines and follow-up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance and reach consensus on timelines for deliverables
• Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
• Manages all aspects of outsourced or internal CSR production and ensures project delivery
• Ensures that medical writing deliverables conform to the International Conference on Harmonization (ICH) and other relevant regulatory guidelines
• Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
• Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
• Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
• Suggets or identifies changes, modifications, and improvements to the document preparation processes and templates to improve quality, efficiency, and productivity
• Aligning with department management to set strategy for meeting department goals

Qualifications

• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
• Must have experience writing INDs, NDAs, MAAs, CSRs, protocols, IBs, briefing documents, and regulatory responses
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills and be attentive to details
• Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
• Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
• Read, write and speak fluent English, excellent verbal and written communication skills
• Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses
• Excellent writing skills coupled with knowledge of the drug development process and regulatory guidelines
• Strong cross-functional collaboration with clinical, regulatory, and biostatistics teams
• Initiative and ability to handle a variety of projects simultaneously
• Excellent interpersonal and communication skills
• Advanced knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT

Education

• BA/BS: 12+ years of relevant corporate medical writing expertise in the pharmaceutical/biotech and/or radiopharma industry; ideally writing in oncology, neurology, cardiology and/or radiopharma; diagnostic/imaging experience a plus
• MS: 10+ years; PhD or PharmD: 8+ years
• Minimum 5 years of leadership or team management experience
• A full understanding of the drug development process
• Broad experience managing the medical writing responsibilities associated with multiple studies at various stages and phases, and in managing the medical writing function
• Experience in interacting with cross-functional study team members