Publication Lead

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:

To fulfill Japan Medical Affairs' (J-MA's) Value Proposition of "realizing a desirable healthcare environment," the following roles are undertaken:

'Publication Lead' plays a crucial role within the VEO & Publication Team in J-MA. Publication Lead is responsible for planning and executing of a comprehensive Japan Publication Strategy, ensuring the development of meeting-to-unmet medical needs (UMNs), feasible, ethically compliant that align with Insmed business including strategic imperatives and Strats/Brand Plan, Global publication strategies/plans, and Japan medical strategies/plans of Insmed portfolio.

Publication Lead collaborates closely with various cross-functional teams within Insmed, including, but not limited to, the Global Publication Team, Global Clinical Development (CD), each function of MA, CD, DSPV, Commercial, and Market Access & Pricing/Patient Advocacy of Insmed GK, as well as external stakeholders and venders.

This position reports to the Director, VEO & Publication in Medical Affairs of Japan.

What You'll Do:

Publication Lead will:

Lead to Develop J-Publication Plans: Lead the development of comprehensive Japan Publication Plans covering the outcomes of a broad range of studies and evidence-generation approaches. Consider feasibility, budget, and publication timing while ensuring alignment with Insmed's strategic imperatives, brand plans, Global Publication Strategies and Plans, and Japan Medical Strategies and Plans across the Insmed portfolio.

Integrate local publication plans developed for each brand and therapeutic area into the relevant Global Publication Plans. Collaborate closely with the Global Publications Team to obtain endorsement from the IET and GPT.

Publication Plans include, but are not limited to, presentations at international and local congresses, original research articles, brief communications, case reports and case series, review articles, meta-analyses, and lay summaries.

Publications may cover, but are not limited to, results from clinical trials (Phases I-III) and post-marketing surveillance, epidemiology, real-world evidence, and patient-reported outcomes. Examples include patient and disease burden, adherence, treatment patterns, clinical practice, effectiveness, quality of life, cost analyses, expert consensus, diagnostic and disease-progression algorithms, and lay summaries.

Lead to Implement Publication Activities: Lead the implementation of day-to-day activities related to publications. Ensure that all activities are executed in compliance with the latest GLs of International Committee of Medical Journal Editors (ICMJE)/Good Publication Practice (GPP), company policies and SOPs, and applicable ethical standards and guidance/GLs for pharmaceutical industries:

• Propose each publication for Global Reviews and Approvals

• Provide publication needs and objectives, develop manuscript/abstract concepts, identify author groups, select service vender, target journals/congress and estimate timelines and budgets.

• Obtain publication endorsement by the Integrated Evidence Team (IET) if original researches/ approaches do not obtain IET endorsement.

• Execute each publication

• Set up the service vender: Obtain estimates, select a service vender and conclude the service agreement. Complete PRs and track administrative processes, e.g., PO release, invoice, payments.

• Select candidate authors:

• Prepare and manage the kick-off meeting: Provide materials required for manuscript/abstract development, e.g., study protocol, CRF, SAP, analysis results/topline results/CSRs, author agreements, key references, candidates of target congresses or journals and draft outlines. Operate the kick-off meeting to finalize publication outlines, author order, especially lead and corresponding authors, target congress/ journals and timelines.

• In case of encore presentations, collect and summarize all information of original presentations at international congresses from Global Pub Team and set up the meeting to choose suitable them as encore presentations for Japan.

• For congress presentations, prepare appropriate 'Disclaimers' that have undergone prior review by Compliance/Legal if necessary, and include the Disclaimer on the slides or poster.

• Oversee/manage the service vender and Medical Writers (MW), ensuring appropriate engagement in activities and contract- and activity-based payment.

• Support the MWs and author groups to facilitate publishing, e.g., close communications with authors, the processes of Global Publication Review (GPR), Disclosure Review Committee (DRC).

• Manage the overall timelines and budgets.

• Update and Share Publication Status/Information: Provide the updated status of planned publications for sharing with stakeholders (e.g., VEO & Pub Team, Sci Comm Team, G-Pub Team, J-Strategic Leads, Commercials and author groups) at appropriate opportunities. Announce accepted and published publications to Japan Leadership Team, G-Pub Team and author groups. Provide and send 'Thank you letter' to principal investigators for accepted/published publications of clinical studies.

• Information Maintenance (Medical venders and journal/congress lists): Actively search for, collect and maintain current and updated information regarding medical venders and journal/congress lists. Additionally, track details about medical venders, including their capabilities, standard budgets/ timelines and contract status.

• Publication training: Provide Publication-related training opportunities for J-MA colleagues and internal author candidates.

• Build Effective Partnerships: Establish strong relationships with all stakeholders, including, but not limited to, internal and external authors, the HEOR Team and Strategic and Sci Comm & Publication Teams of Global MA (GMA), CD and DSPV in both Global and Local. Collaborate with other functions within J-MA, and Market Access & Pricing/Patient Advocacy, Legal/ Compliance, and working groups.

Who You Are:

• Educational Requirements: A Master's degree in a scientific discipline or equivalent experience is highly preferred. A candidate with the Bachelor's degree will be considered if the candidate has significant publication experience. Scientific expertise in pulmonology, bacterial infection, cardiovascular diseases and/or allergy/ immunology and HTA expertise are highly valued.
• Professional Experience and Certificates: Minimum 5-7 years' relevant experience in the pharmaceutical/ biotech industries within a Global setting, specifically in Japan is required, with solid understandings of the pharmaceutical business, including drug research & development, manufacturing and commercialization, regulation and guidelines/guidance for pharmaceutical industries and MA activities. Of these, at least 4 years must be focused on publications as a Publication Lead or Manager, with demonstrated expertise in all aspects of planning scientific publication strategy and execution across all phases of drug development and post-launch/marketed products. In addition, a minimum of three years of people management experience is required, preferably within a Publications team. Certification as a Certified Medical Publication Professional (CMPP) through the International Society for Medical Publication Professionals (ISMPP) is highly desirable. Individuals who do not hold the certification will be required to obtain it within one year of joining the company or being appointed to this role, as applicable. Experience in creating conference presentation materials and drafting manuscripts (in English and Japanese) as a Professional Medical Writer is desirable.
• Key Competencies: Broad experience and reliable understanding in variety of publications and reporting guidelines. Solid experience in playing critical roles in development of comprehensive publication strategies/plans and managing operations in publications (e.g., vendor selection/management, journal/congress proposal and journal/ publisher management, schedule planning, author management, creation and management of lists for venders, journals and congresses, budgets and timelines management) for all publications.
• Developed annual publication plans: 4 or more
• Completed congress presentations: 5 or more/year
• Published manuscripts: 3 or more/ year
• In-depth knowledge and understanding of GPP and ICMJE guidance (trainer level)
• Solid understanding of clinical trials, real-world study and reporting guidelines, e.g., CONSORT, STROBE, PRISMA (trainer level)
• 'Datavision' operation.
• Published manuscript for systematic review/meta-analysis and lay summaries
• Experience of digital/innovative publications
• Experience managing critical issues at a study-team level (e.g.: unexpected clinical trial results, competitor issues, author conflicts, etc.) is preferred.
• Solid experience in collaborating cross-functional team consisting of both medical/scientific experts and operational/administrative professionals
• Language: Native-level fluency in Japanese and high-level business fluency in English.
• Ethics and compliance: Adherence to uncompromising ethical standards. Solid understanding of applicable local and global policies, rules and regulations as well as compliance policies and requirements of the pharmaceutical industry in Japan.
• Communication/Presentation: Ability to quickly understand and dialogue on subjects that are at the interface between medicine and policy. Ability to connect science/ medicine and unmet medical need to MA strategy. Excellent in disseminating and communicating complex scientific information and data in an impactful while balanced and user-friendly way. Excellent intra-personal and presentation skills (verbal and written, in Japanese and English) with the ability to effectively present ideas, and influence and negotiate with others to achieve desired goals.
• People: Works productively across local and global organizations as a team player and supervisor. Ability to influence without authority.
• Compliance and Ethical Standards: Adherence to uncompromising ethical standards, including but not limited to, applicable local and global policies, regulations, laws and guidelines such as: GCP, Clinical Study Act, Ethical GLs for life science/ medical and health research involving human subjects, GLs of International Committee of Medical Journal Editors (ICMJE)/present Good Publication Practice (GPP), company policy and SOPs as well as compliance policies and requirements, Japan Pharmaceutical of Manufacturers Association (JPMA) GLs, and Guidelines for Provision of Sales Information on Prescription Drugs.
• Language and Communication Skills: Native-level fluency in Japanese and high-level business fluency in English is a must. Excellent written and verbal communication and presentation skills, with the ability to effectively convey complex scientific and clinical data to both internal and external stakeholders (e.g., scientific congresses, meetings with Global teams).
• Key attributes for success: Leadership and analytical skills with the ability to work autonomously and within cross-functional teams. Effective management of multiple workstreams while maintaining the ability to prioritize tasks.
• Must demonstrate Insmed's five core corporate competencies: Collaboration, Accountability, Passion, Respect and Integrity. Strong interpersonal skills and the ability to succeed in a dynamic and culturally diverse workplace
• Non-smoker

Where You'll Work

This role is based out of our Tokyo office with weekly flexibility to support both your professional and personal needs.

This role requires up to 30% travel for congresses in Japan and overseas, meetings with external stakeholders and venders, and meetings in offices of Insmed Inc.

Life at Insmed

ESPP

LinkedIn Learning

AI

IT

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to recruitmentfraud@insmed.com.