What are the responsibilities and job description for the Senior Director, Medical Writing (Oncology) position at YOH Services LLC?
Senior Director, Medical Writing (Contract)
Location: Remote
Duration: 12-Month Contract
Pay Rate: $150-175/hour DOE
An innovative clinical-stage biotechnology company is seeking a Senior Director, Medical Writing to provide strategic and operational leadership for clinical and regulatory documentation supporting global oncology development programs- early and late stage. This individual will lead medical writing strategy, oversee document development, and ensure the timely delivery of high-quality regulatory documents.
Responsibilities
Estimated Min Rate: $150.00
Estimated Max Rate: $175.00
What's In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice
Stay Safe During Your Job Search
Fraudulent recruiting communications have become increasingly common. Emails from Yoh recruiters will only come from an @yoh.com email address. Yoh will never ask candidates to pay fees, purchase equipment, send gift cards, or transfer funds as part of the recruiting or hiring process. If you receive a communication that appears suspicious or requests payment, contact Yoh directly before responding or sharing personal information.
Location: Remote
Duration: 12-Month Contract
Pay Rate: $150-175/hour DOE
An innovative clinical-stage biotechnology company is seeking a Senior Director, Medical Writing to provide strategic and operational leadership for clinical and regulatory documentation supporting global oncology development programs- early and late stage. This individual will lead medical writing strategy, oversee document development, and ensure the timely delivery of high-quality regulatory documents.
Responsibilities
- Lead the planning, authoring, review, and delivery of clinical and regulatory documents supporting oncology development programs.
- Develop document strategies, timelines, and resource plans across multiple programs.
- Oversee the preparation of key regulatory documents, including INDs, BLAs, clinical study protocols, Investigator's Brochures, and Clinical Study Reports (CSRs).
- Lead document review processes and drive documents through final approval.
- Manage medical writing vendors, budgets, and resources.
- Provide leadership and mentorship to a medical writing team while ensuring high-quality, compliant documentation.
- Advanced degree (PhD, PharmD, MD, MS, or equivalent) in a life sciences discipline.
- 10 years of medical writing experience within the biotechnology or pharmaceutical industry
- 5 years of leadership experience managing medical writing teams at a sponsor company (Not FSP, must be FTE)
- Extensive oncology medical writing experience is required.
- Experience authoring or leading at least one successful IND or BLA submission.
- Strong experience developing clinical and regulatory documents, including protocols, Investigator's Brochures, and Clinical Study Reports.
- Strong knowledge of ICH, GCP, and global regulatory requirements.
- Proven ability to manage complex writing projects, vendors, and multiple priorities.
- Excellent scientific writing, communication, and organizational skills.
- Experience working in a fast-paced biotechnology environment preferred.
- Experience utilizing AI-enabled document development tools is a plus.
Estimated Min Rate: $150.00
Estimated Max Rate: $175.00
What's In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20 hours per week)
- Health Savings Account (HSA) (for employees working 20 hours per week)
- Life & Disability Insurance (for employees working 20 hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice
Stay Safe During Your Job Search
Fraudulent recruiting communications have become increasingly common. Emails from Yoh recruiters will only come from an @yoh.com email address. Yoh will never ask candidates to pay fees, purchase equipment, send gift cards, or transfer funds as part of the recruiting or hiring process. If you receive a communication that appears suspicious or requests payment, contact Yoh directly before responding or sharing personal information.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
Salary : $150 - $175