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.
We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
- Results Driven
- Team Player
Life at Takeda
A Global Top Employer
Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2020.
Check Out Takeda’s Cambridge Office
View a panoramic tour of the Cambridge office, study a map of the Takeda campus, and see all the amazing nearby attractions
Research & Development
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.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.
Principal Medical WriterApply Now
Principal Medical Writer
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Principal Medical Writer 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 Principal Medical Writer working on the Medical Writing team, you will be empowered to formulate the writing strategy for key clinical and regulatory documents and regulatory submissions; guide medical writing document preparation coordination of assignments to Takeda and contract writers; provides review and substantive editing of documents. In this role, you will contribute to Takeda’s mission by working across therapeutic areas to provide expert support. A typical day will include:
- Working across therapeutic areas to provide expert support as needed the Principal Medical Writer formulates the writing strategy for key clinical and regulatory documents and regulatory submissions; guides medical writing document preparation, including coordination of assignments to Takeda and contract writers; provides review and substantive editing of documents.
- As necessary, may assume primary responsibility for preparation of key clinical and regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities.
- Formulate 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.
- Provide 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.
- Collaborate with internal and external resources to achieve high quality, timely program level submission deliverables.
- Reporting to a Medical Writing Team Lead, the Principal Medical Writer guides medical writing activities for key clinical and regulatory documents and regulatory submissions.
- Lead 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.
- Coordinate the activities of Takeda, contract employees and vendors (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
- Manage 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.
- Represent Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
- As required, serves as lead writer for important clinical and regulatory documents and key components of regulatory submissions, as well as responses to regulatory agencies/ health authorities.
- Provide leadership on functional teams that address requirements or issues related to document preparation and production.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree is required.
- At least 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is 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.
- 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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Job ID R0022901