Technical Writing Supervisor jobs in Massachusetts
Technical Writing Supervisor supervises the daily activities of technical writers. Ensures standard documentation methods are followed by staff. Being a Technical Writing Supervisor provides guidance on writing complex technical documentations. Requires a bachelor's degree. Additionally, Technical Writing Supervisor typically reports to a manager. Working team member that may validate or coordinate the work of others on a support team. Suggests improvements to process, is a knowledge resource for other team members. Has no authority for staff actions. Generally has a minimum of 2 years experience as an individual contributor. Thorough knowledge of the team processes. (Copyright 2024 Salary.com)
Recently Added Technical Writing Supervisor jobs
Manager, Technical Writing, CMC
- Xenon Pharmaceuticals Inc.
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Boston, MA
FULL_TIME
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Who We Are:
Xenon Pharmaceuticals (NASDAQ: XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
What We Do:
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our XEN1101 Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures. In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
About the Role:
We are seeking a Manager, Technical Writing, CMC to join our growing team. The ideal candidate should be an independent and self-directed contributor who will be responsible for converting scientific data into clear, scientifically sound, well-structured scientific, technical, and regulatory documents intended for global health authorities and internal and external stakeholders. The Manager, Technical Writing, CMC, will author and manage the review and approval of CMC regulatory documents, including Module 2 and Module 3 CMC regulatory submissions, technical reports, and SOPs in close collaboration with critical functions within the CMC function.
This position reports to the Senior Director, Regulatory Affairs, CMC and will be in Vancouver, BC, Canada or Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience.
RESPONSIBILITIES:
- Author and edit the CMC sections of regulatory filings across all assets and clinical and commercial phases, including Module 2 & 3 submissions, IND/IMPDs, marketing applications, supplements, amendments, and annual reports, as needed.
- Plan, manage and execute the authoring and review of CMC regulatory documents and deliver on timelines for submissions.
- Manage and contribute strategy to responses to CMC queries and Requests for Information received from global health authorities.
- Summarize scientific information from development reports and identify details relevant to regulatory clinical and commercial phase submissions supporting regulatory strategy.
- Review documents for consistency and quality.
- Develop processes and best practices to facilitate organization of information in preparation for clinical and marketing applications for Xenon products.
- Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed.
- Other duties as assigned.
- A Bachelor’s or Master’s degree in pharmaceutical/life sciences, technical or medical writing, or a related field is strongly preferred.
- 5 years working in the pharmaceutical industry, with an emphasis on authoring CMC regulatory content.
- Proficiency in evaluating data, summarizing reports, authoring, and reviewing documents, and communicating results to internal and external stakeholders.
- Extensive knowledge of eCTD structure and subsections.
- Demonstrated, hands-on experience, managing and preparing regulatory submissions including INDs/CTAs and/or marketing applications, supplements and variations.
- Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs.
Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted. - 2 Months Ago
Manager, Technical Writing, CMC
- xenon
-
Boston, MA
FULL_TIME
- Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the liv...
- 2 Months Ago
Adult Career and Technical Education Supervisor - Anticipated FY25
- Tri-County Regional Vocational Technical High...
-
Franklin, MA
FULL_TIME
- PERFORMANCE ACCOUNTABILITIES: This position requires 1-2 nights per week on an alternating basis while adult education programming is in session.RESPONSIBILITIES: Staffing Interview prospective teache...
- 19 Days Ago
Adult Career and Technical Education Supervisor - Anticipated FY25
- Tri-County Regional Vocational Technical High School
-
Franklin, MA
FULL_TIME
- PERFORMANCE ACCOUNTABILITIES: This position requires 1-2 nights per week on an alternating basis while adult education programming is in session. RESPONSIBILITIES: Staffing • Interview prospective tea...
- 22 Days Ago
Welding Supervisor
- BlackTree Technical Group, Inc.
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Ayer, MA
FULL_TIME
- Job DescriptionThe Welding Supervisor is primarily responsible for overseeing and leading a team of direct labor associates in the manufacture and assembly of products, components and parts for custom...
- Just Posted
QC Supervisor
- BlackTree Technical Group, Inc.
-
Ayer, MA
FULL_TIME
- Job DescriptionLeading and developing people, processes, and systems to ensure quality, safety, productivity, and efficiencyEnsuring that products and services meet or exceed government, industry, and...
- 4 Days Ago
Technical Writing Supervisor jobs at Popular Companies
HSES Technical Supervisor
- CB&I
-
Clive, IA
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Maintenance Technical Supervisor
- Cambrex High Point
-
Charles City, IA
- Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organizati...
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Technical Supervisor, Theatre
- Joliet Junior College
-
Joliet, IL
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- 6/1/2024 12:00:00 AM
Maintenance Technical Supervisor
- Cambrex
-
Charles City, IA
- Overview: The Maintenance Technical Supervisor is responsible for providing oversight of the contracted MRO service prov...
- 6/1/2024 12:00:00 AM
Technical Supervisor
- University Health System- San Antonio
-
San Antonio, TX
- We are currently looking for a Technical Supervisorto join our team. This is an exciting opportunity to join a company w...
- 5/30/2024 12:00:00 AM
Laboratory Technical Supervisor
- Salinas Valley Memorial Healthcare System
-
Salinas, CA
- It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and ...
- 5/30/2024 12:00:00 AM
Technical Supervisor
- Idaho State Job Bank
-
Nampa, ID
- Technical Supervisor at CBRE in Nampa, Idaho, United States Job Description Technical Supervisor Job ID 158073 Posted 06...
- 5/29/2024 12:00:00 AM
Technical Supervisor
- University Health
-
San Antonio, TX
- We are currently looking for a Technical Supervisorto join our team. This is an exciting opportunity to join a company w...
- 5/29/2024 12:00:00 AM
About Massachusetts
Massachusetts is the 7th-smallest state in the United States. It is located in the New England region of the northeastern United States and has an area of 10,555 square miles (27,340 km2), 25.7% of which is water. Several large bays distinctly shape its coast. Boston is the largest city, at the inmost point of Massachusetts Bay, and the mouth of the Charles River.
Despite its small size, Massachusetts features numerous topographically distinctive regions. The large coastal plain of the Atlantic Ocean in the eastern section of the state contains Greater Boston, along with most of the state's po...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Technical Writing Supervisor jobs
$73,451 to $100,180
Most Popular Cities in Massachusetts for Technical Writing Supervisor Jobs
What does a Technical Writing Supervisor do?
Technical Writing Supervisor in Shakopee, MN
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