Executive Director, Medical Writing

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden.  For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. 

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.  At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.  Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands.  We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. 

This position is primarily site-based and requires a presence on-site three days per week. 

Summary of Role

The Executive Director, Medical Writing collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.

Key Responsibilities/Essential Functions

• 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
• Suggests 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 pr