Lead Medical Writer - Oncology, Remote
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Writer, Remote in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Lead Medical Writer working on the Medical Writing team, you will be empowered to support Takeda business objectives within a therapeutic area. In this role, you will contribute to Takeda's mission by supporting leadership and strategic direction to cross functional project teams. A typical day will include:
Responsible for medical writing activities that support Takeda business objectives within a therapeutic area (one or more products or indications).
Provides leadership and strategic direction to cross functional project teams to ensure that clinical regulatory documents (including investigator's brochures, study protocols and amendments, study reports, clinical/integrated summaries, clinical overviews, contributions to briefing documents, response documents, and other IND/CTA or global regulatory submission documents as appropriate) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of clinical data are maintained from concept to licensing and disclosure.
Write and assume primary responsibility for clinical regulatory documents or provide direction to other writers (as needed) to ensure the timely delivery of high quality documents that are scientifically rigorous and logically organized, with accurate data presentation and interpretation; effectively delegates and intervenes as required to maintain optimal productivity; guides document preparation, including coordination of assignments to Takeda and contract writers, review, and substantive editing of documents; formulates writing approach for assigned regulatory submissions and projects.
Participate in departmental and/or cross-functional initiatives and task forces.
The Lead Medical Writer reports to the Medical Writing Team Lead.
Guides medical writing activities (including document preparation and/or production) for assigned regulatory submissions or projects.
Formulates writing strategy for key documents, including organization, content, timelines, and resource requirements; ensures that needs (e.g. headcount, funding, time) are appropriately represented to relevant teams and management.
Writing, development of timelines, project management of deliverables, and participation on project teams. (performed with minimal oversight)
In addition to program responsibilities, the Lead may lead or participate in departmental or cross-functional initiatives designed to establish highly efficient processes, best practices, and productive cross-functional collaboration.
Responsible for mentoring of less experienced writers and oversight of external service providers; coordinates the activities of Takeda and contract employees (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Bachelor's degree required; 5+ years of experience in clinical/pharmaceutical development with directly related medical/scientific writing experience.
Advanced degree in a relevant scientific/clinical/regulatory field preferred.
Global regulatory submission experience preferred.
Leadership and mentoring skills.
Ability, with minimal oversight, to lead the development, review, and approval of all clinical regulatory document types.
Ability to analytically evaluate and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical and therapeutic teams.
Strong project management skills including understanding of clinical timelines (study and submission level), working knowledge of the roles of other functional areas and interdependencies among groups; ability to establish detailed timelines for completion of assigned projects and ensure efficient, timely completion.
Ability to appropriately manage resourcing across multiple projects with competing workload priorities.
Strong oral and written communication skills.
Ability to interact effectively with team members to facilitate information exchange (including problem solving and issue resolution). Working knowledge of current global regulatory requirements/guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents.
Excellent working knowledge of writing-related computer software, templates, and electronic document management systems.
Cell Therapy experience a plus
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
Base Salary Range: $102,200-$146,000 based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
Empowering Our People to Shine
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Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Massachusetts - Virtual