Principal Medical Writer
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.
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By focusing R&D efforts on four therapeutic areas and other targeted investments, our aim is to thrive at the cutting edge of innovation that solves unmet medical needs, through internal R&D and in collaboration with cross-industry partners. We have the scale and expertise to be a leading global, Values-based, R&D-driven biopharmaceutical company with dynamic, focused R&D efforts.
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Principal Medical WriterApply Now
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 Principal Medical Writer in our Cambridge office.
Within a designated therapeutic or functional area leads a single team which formulates the writing strategy for key response documents and regulatory submissions Guides medical writing 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 submission. Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area. 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, 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. Leverages internal and external resources to achieve quality, timely and cost-effective compound level submission deliverables.
- Leads a single team which guides medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions.
- Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
- Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
- Coordinates the activities of Takeda, contract employees and vendors (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
- Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Takeda requirements and processes across development programs.
- 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.
- The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.
EDUCATION, EXPERIENCE AND SKILLS:
- Bachelor’s degree in science, health profession, or journalism required.
- At least 5 years experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
- Experience as lead writer for key documents included in major US and/or international regulatory submissions required
- Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.
- Knowledge and Skills:
- Knowledge and 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.
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.
Job ID R0011676