at Takeda Pharmaceuticals in Dover, Delaware, United States
About the role:
As remote Principal Medical Writer, you will provide medical writing support to cell therapy project teams, ensuring successful preparation of high-quality submission-ready documents and implementation of Takeda writing processes. You will also provide medical writing expertise for multiple cell therapy projects. You will work with external groups (eg, Clinical, Regulatory, Biostatistics, Nonclinical, Translational Medicine, Reg CMC, Data Management, and Publishing) to ensure accurate completion of document deliverables, including support of complex regulatory submissions to the FDA and international regulatory agencies.
How you will contribute:
+ Be the Medical Writing Lead on clinical/regulatory documents to support cellular therapy projects and US and ex-US submissions; experience in early phase development preferred.
+ Work with clinical and regulatory team(s) on document strategies for cellular therapy clinical study documents and submissions (eg, pre-INDs, INDs, and regulatory responses). Additionally, works with Reg CMC, preclinical (analytical development, process development), translational medicine, and pharmacology/toxicology in preparation of complex pre-INDs, INDs, and regulatory responses.
+ Present and incorporate relevant data from cross-functional groups into documents in a manner consistent with regulatory requirements. Ensure compliance to regulatory guidance and Takeda writing processes. Coordinate document review meetings with project teams and ensure approval of clinical study and submission documents.
+ Maintain knowledge of ICH; and US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions for cellular therapy products.
+ Communicate with team members (eg, deliverables needed, writing processes, and timelines).
+ Work with Quality Assurance throughout clinical regulatory document audit process, answer questions during the audit process, and work with team to draft responses.
+ Be a Subject Matter Expert for assigned clinical teams regarding computer-based technologies and writing processes used at Takeda (eg, PleaseReview and Documentum-based archival system). Mentor and assist Takeda and non-Takeda medical writers.
+ Bachelor’s degree, with relevant writing experience required. Masters or PhD in science discipline preferred with relevant writing experience.
+ 7 years relevant experience in medical writing in the biopharmaceutical industry required, including oncology
+ High-level content writing experience and experience with all types of clinical regulatory documents required. Working knowledge of statistical concepts and techniques very helpful.
+ Experience with PleaseReview helpful.
+ Experience working with collaborative, cross-functional teams.
What Takeda can offer you:
+ Comprehensive Healthcare: Medical, Dental, and Vision
+ Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
+ 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 and company match of charitable contributions
+ Family Planning Support
+ Flexible Work Paths
+ Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
. This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
Base Salary Range : $130,200 Range Min to $186,000 Range Mid, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado’s Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq
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.
Massachusetts – Virtual
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