Principal Medical Writer, Plasma-Derived Therapies
Company: Takeda Pharmaceutical
Location: Newark
Posted on: May 13, 2022
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Job Description:
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to the best of my knowledge.
Job Description
Principal Medical Writer Plasma-Derived Therapies
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, - Plasma-Derived Therapies in our
Cambridge, MA 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, - Plasma-Derived Therapies working
on the Medical Writing PDT team, you will be empowered provide
expert support as needed the Principal Medical Writer formulates
the writing strategy for key clinical and regulatory documents and
regulatory. A typical day will include:
POSITION OBJECTIVES:
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.
POSITION ACCOUNTABILITIES:
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).
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.
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
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.
*RM-LI
EEO Statement
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
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Newark , Principal Medical Writer, Plasma-Derived Therapies, Healthcare , Newark, New Jersey
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