Sr 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 in Bedford, MA.

Summary of role

The Senior 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 Medical Writing function and provide necessary Medical Writing capabilities for Lantheus.
• Prepare, edit, and finalize protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts; oversee other Medical Writers, as needed, to ensure high-quality Medical Writing deliverables.
• Participate in scientific communication planning, including development of strategic medical communication plans.
• Partner with the study biostatistician 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.
• Work closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
• Schedule and conduct 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.
• Manage the document review process ensuring conflicting comments are appropriately addressed.
• Complete 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.
• Understand the functions and roles within the study team and align with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations.
• Manage all aspects of outsourced or internal CSR production and ensure project delivery
• Ensure that medical writing deliverables conform to the International Conference on Harmonization (ICH) and other relevant regulatory guidelines.
• Create and maintain standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables.
• Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system.
• Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements.
• Suggest or identify changes, modifications, and improvements to the document preparation processes and templates to improve quality, efficiency, and productivity.
• Align 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.
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; 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.
• Effective collaborator with ability to foster strong working relationships and build consensus among colleagues on cross-functional 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 and Experience

• (BA/BS) +8 years, (MS) +6 years, (Ph.D. or PharmD) Doctoral degree +4 years of relevant corporate medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology, neurology, or rare diseases therapeutic areas.
• Minimum 6 years of regulatory writing and submission experience.
• An understanding of the drug development process.
• Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.
• Experience in interacting with cross-functional study team members.

Core Values

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.