Associate Director, Medical Writing, Plasma-Derived Therapies
Company: Takeda Pharmaceutical
Posted on: May 12, 2022
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Associate Director, Medical Writing , Plasma-Derived Therapies
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
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
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.
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
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)
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
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,
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
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
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.
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.
Keywords: Takeda Pharmaceutical, Tenafly , Associate Director, Medical Writing, Plasma-Derived Therapies, Advertising , Montvale, New Jersey
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