Principal Medical Writer
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 6, 2022
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionPrincipal Medical WriterAre 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, MA site.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; guides medical writing document preparation, including
coordination of assignments to Takeda and contract writers;
provides review and substantive editing of documents.A typical day
will include:POSITION OBJECTIVES:
- Prepare 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.
- Participate 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.POSITION
- Guide 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. -
- Provide 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).
- Serve 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 7 years of experience writing clinical/regulatory
documents for a pharmaceutical or biotechnology company is
- 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)
- 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
- Well-developed oral and written communication skills; ability
to clearly present technical information within and across
- Demonstrated problem-solving and interpersonal skills that
facilitate effective interactions within functional and
cross-functional teams and with external providers.Takeda U.S.
Vaccine Requirement:Absent an approved religious or medical reason,
all US office-based and lab-based Takeda employees who work fully
on-site or in a hybrid model (as determined by Takeda) must be
fully vaccinated to work at a Takeda site or to engage with Takeda
colleagues or anyone else on behalf of Takeda. US field-based
employees must be fully vaccinated as a condition of employment,
absent an approved religious or medical reason. US employees who
work at a Takeda manufacturing facility, and those who work at a
BioLife center or BioLife lab, may be subject to different
guidelines. If you are contacted by a Takeda recruiter about your
job application, we encourage you to seek more information on the
applicable guidelines for the Business Unit/Function to which you
have applied.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
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsEmpowering Our People to
ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters
Please.*KB-LI---EEO StatementTakeda 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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cherry Hill , Principal Medical Writer, Other , Cherry Hill, New Jersey
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