Principal Medical Writer, GI - Remote
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 or Lexington 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 with a focus on Gastroenterology 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.
- 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.
- 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.
- The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor s degree is required.
- At least 7 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.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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
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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. Locations
USA - MA - Cambridge
Massachusetts - Virtual Worker Type
Employee Worker Sub-Type
Regular Time Type