Associate Director, Medical Writing, Plasma-Derived Therapies
Company: Takeda Pharmaceutical
Location: Cherry Hill
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 DescriptionAssociate Director, Medical Writing,
Plasma-Derived TherapiesPOSITION OBJECTIVES:
- Responsible for medical writing activities for a program or
multiple programs within a therapeutic area depending on the scope
and stage of clinical development and may or may not have direct
reports.
- Provides strategic direction to cross-functional project teams
to ensure that clinical regulatory documents (eg, investigators'
brochures, study protocol and amendments, study reports, marketing
authorization submission documents) accurately and consistently
present key clinical messages in accordance with program goals and
regulatory requirements. Provides direction and leadership to other
writers to ensure the timely delivery of high-quality documents
that are scientifically rigorous, logically organized, and which
provide accurate data presentation and interpretation.
- Responsible for a non-project related activities (eg, subject
matter expert for a process), and generally leads or participates
on departmental or cross-functional initiatives designed to
establish best practices and efficient cross-functional
collaboration.
- Contributes to therapeutic area project teams as the medical
writing expert for regulatory submission documents. Collaborates
with all Takeda regions to ensure a medical writing regulatory
document strategy is created and executed upon for all products
within area of responsibility.POSITION ACCOUNTABILITIES:
- Leads 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 employees, contract
employees and vendors (on-site or external), provides review and
substantive editing of contributions, and ensures resolution of
issues.
- Within designated therapeutic area, manages 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, as well as Takeda
requirements and processes across development programs.
- Represents Medical Writing on cross-functional teams and task
forces (related to projects, process, and standards). As required,
serves as lead writer for important regulatory response documents
and key components of regulatory submissions.EDUCATION, BEHAVIORAL
COMPETENCIES AND SKILLS:
- Advanced degree in a relevant scientific/clinical/regulatory
field preferred; Bachelor's degree is required.
- At least 10 years of experience writing clinical/regulatory
documents for a pharmaceutical or biotechnology company is
required.
- Experience with Plasma-Derived Therapies
- 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.
- Demonstrated ability to understand and interpret clinical and
scientific data with minimal oversight; ability to define data
presentation to meet key messages developed by the clinical
team.
- Demonstrated ability to independently lead the development,
review, and approval of all clinical document types (ie, those
typically developed by MW) and the ability to identify any new or
unique document types which may require a different approach.
- Excellent project management skills including in depth
understanding of clinical timelines (study and submission level)
and working knowledge of roles of other functional areas and the
interdependencies among groups.
- Working knowledge of current global regulatory
requirements/guidelines applicable to clinical research (eg,
GCP).
- Working knowledge of the regulatory guidance(s) regarding
content for various document types including, but not limited to,
ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E, EMA guidance on
RMPs).In accordance with the CO Equal Pay Act, Colorado Applicants
Are Not Permitted to Apply. -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.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.*RM-LIEEO 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 , Associate Director, Medical Writing, Plasma-Derived Therapies, Executive , Cherry Hill, New Jersey
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