Principal Medical Writer- GI - Remote
Company: Takeda Pharmaceutical
Location: New Milford
Posted on: May 11, 2022
Job Description:
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 Writer, GI - RemoteAre
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:POSITION OBJECTIVES:
- 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.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).
- 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 ProgramsEmpowering Our People to
ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters
Please.*LI_RMEEO 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.LocationsUSA - MA -
CambridgeMassachusetts - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Clifton , Principal Medical Writer- GI - Remote, Advertising , New Milford, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...