Senior Medical Writer, Publications

AIM OF THE POSITION

The Senior Medical Publications Writer is an expert in publication writing and performs work independently. Reporting to the VP, Clinical Development, the Senior Medical Publications Writer will play a pivotal role in the development and execution of publication plans and lead scientific communication efforts by developing high-quality, evidence-based publications and congress materials, ensuring alignment in company objectives and adherence to good publication practices. This role will work cross-functionally with Medical and Clinical Affairs, Commercial, and with external investigators.

POSITION WITHIN THE ORGANIZATION

1. Reports to Vice President, Clinical Development

2. Cooperates with all departments

3. Participates in:

- Cross-functional projects and meetings

ESSENTIAL DUTIES AND RESPONSIBILITIES

Publication Planning and Execution:

* Lead the development and execution of scientific publication plans for clinical trials, real-world evidence studies, and translational research findings within pre-established timelines

* Develop high-impact manuscripts, abstracts, posters and presentations for peer-reviewed journals and scientific congresses in collaboration with cross-functional teams.

* Ensure alignment of publication strategies with the company's medical and clinical objectives, supporting evidence generation and dissemination initiatives

* Maintain a thorough understanding of the competitive landscape, identifying key areas for publication and differentiation in the oncology space.

* Participate in and assist with meetings and discussions with cross-functional teams to develop a publication strategy and ensure all stakeholders are involved in the publication process.

Scientific Writing and Data Interpretation:

* Translate complex clinical and scientific data into clear, compelling, and scientifically accurate publications tailored to diverse audiences, including oncologists, researchers, and regulatory bodies.

* Collaborate with biostatisticians and data scientists to analyze and interpret clinical and real-world evidence, ensuring statistical accuracy and clinical relevance.

* Perform literature reviews and competitive analyses to support publication development, ensuring manuscripts are well contextualized within the existing body of evidence.

* Assist in the development of scientific communication materials, such as educational slide decks, white papers, and executive summaries, to support internal and external stakeholders.

Project and Publication Management:

* Manage multiple concurrent publication projects, ensuring timelines, and deliverables are met with scientific rigor and operational excellence.

* Oversee the manuscript review process, coordinating with authors, internal teams, and journal editors to ensure timely submission and publication

* Helps coordinate publications/presentations/congress events with marketing for appropriate visibility (i.e. press releases, poster and presentation summaries)

* Maintain publication libraries, reference databases, and literature repositories for streamlined access and organization.

Compliance and Ethical Standards:

* Ensure publications comply with AMA writing style, Good Publication Practices (GPP), ICMJE guidelines, and Agendia-specific SOPs.

* Participate in post-market surveillance efforts by evaluating new literature, summarizing emerging data, and contributing to updates on clinical and scientific positioning.

Cross-Functional and External Collaboration:

* Work closely with internal stakeholders (Medical Affairs, Clinical Development, R&D, and Marketing) and external authors (Key Opinion Leaders, investigators, and collaborators) to develop impactful scientific communications

* Partner with the Medical Science Liaison (MSL) team, Marketing, and other stakeholders to ensure publications align with field insights and unmet medical needs

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

KEY CONTACTS

Internal

o Medical and Clinical Affairs teams, Marketing and R&D

External

o Works closely with external collaborators (i.e. KOLs, investigators, physicians and researchers)

EDUCATION AND EXPERIENCE REQUIREMENTS

EDUCATION

* PhD, PharmD, or MD in Biomedical Sciences, Oncology, Molecular Biology, or a related field.

* Master's degree with significant publication experience may be considered

EXPERIENCE

* 5+ years of experience in medical writing, publication planning, or scientific communications within oncology, diagnostics, or the pharmaceutical/biotech industry.

* Proven track record of first-authorship in peer-reviewed journals and scientific congress presentations.

* Strong understanding of oncology research, biomarker-driven therapies, and precision medicine approaches.

* Experience working with real-world evidence, translational research, and clinical trial publications is highly desirable.

* Proficiency with publication management software, reference management tools (EndNote, Mendeley), and literature databases (PubMed)

KNOWLEDGE, SKILLS AND ABILITIES (KSA'S)

Specific Knowledge Required:

Knowledge: Comprehension of a body of information acquired by experience or study.

Skill: A present, observable competence to perform a learned activity.

Ability: Competence to perform an observable behavior.

* Expert-level scientific writing and editing skills, with the ability to synthesize complex data into compelling narratives.

* Strong analytical skills, with a deep understanding of biostatistics, data visualization, and clinical study design.

* Demonstrated ability to manage multiple high-priority projects in a fast-paced environment.

* Exceptional stakeholder engagement and project management skills, with experience leading cross-functional teams.

* High level of attention to detail, scientific integrity, and commitment to excellence in publication development.

* Proficiency in the following tools:

o Data Visualization software (i.e. Adobe Illustrator, PowerPoint, Microsoft Excel, GraphPad Prism)

o Manuscript development tools (Microsoft Office Word).

o Reference managers (Endnote, Mendeley)

* Knowledge and experience in performing data analysis a significant plus

* Preferably, experience with reference management software such as EndNote, Mendeley

BEHAVIOURAL COMPETENCIES/DESIRED SKILLS

o Ability to multi-task

o Result - and customer orientation

o Self-organization

o Quality oriented and results focused

o Initiative

o Flexibility

o Can do-attitude

* PRIVACY NOTICE: To review the California privacy notice, click here: https://agendia.com/privacy-policy/

* Employees must not be classified as an excluded individual who is prohibited from participation in any Federal health care program.

WORKING ENVIRONMENT

Establishes ADA (Americans with Disabilities Act) requirements

ENVIRONMENT/SAFETY/WORK CONDITIONS

Working conditions (inside or outside the office).

General office environment. Adheres to Department Specific Safety Guidelines.

TRAVEL

o Ability to drive/fly domestically up to 10%

OTHER DUTIES

Other duties as required.