Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Writer in our Cambridge office.
Formulates writing strategy for assigned regulatory submissions or key projects (e.g. response documents). Guides document preparation, including coordination of assignments to Takeda and contract writers, review, and substantive editing of documents. As necessary, may assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submissions. Formulates writing approach for assigned regulatory submissions and projects. Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation and production, including US and international regulatory guidance and requirements for content and format, Takeda requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents. Effectively delegates and intervenes as required to maintain optimal productivity. Provides leadership on functional teams that address requirements or issues related to document preparation and production. The Lead Writer, Medical Writing should be a dedicated resource to a submission or project, reporting to a Manager or Sr. Manager who is responsible for a therapeutic or functional area.
- 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.
- Coordinates the activities of Takeda and contract employees (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
- Prepares documents for submission to FDA or other regulatory agencies, ensuring consistency of content within the assigned submission or project and adherence to regulatory requirements and Takeda requirements and processes.
- Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
- As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
- Provides leadership on functional teams that address requirements or issues related to document preparation and production.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor s degree in science, health profession, or journalism.
- 5 years experience writing for pharmaceutical or biotechnology, including electronic documents and submissions.
- Experience as senior writer for key eCTD documents included in major US and/or international regulatory submissions.
- Advanced degree in science, health profession, or journalism.
Knowledge & Skills
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
- Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
- Ability to understand Takeda guidelines and requirements related to the preparation and production of regulatory documents and submissions.
- Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.
- Knowledge of team dynamics and ability to function as a team leader.
- Technical leadership skills and understanding of managing people.
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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.