Lantheus is hiring : Executive Director, Medical Writing in Bedford

Overview 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 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 & Experience BA / BS) 12+ years, (MS) 10+ years, (Ph.D. or PharmD) Doctoral Degree 8+ years of relevant corporate medical writing expertise in the pharmaceutical / biotech and / or radio pharma industry, ideally writing in oncology, neurology, cardiology and / or radio pharma; diagnostic / imaging experience a plus

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

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.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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