Technical Writing Supervisor jobs in Framingham, MA
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
-
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. - 20 Days 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...
- 20 Days Ago
Laboratory Supervisor
- Mentor Technical Group
-
Boston, MA
FULL_TIME
- Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions...
- 6 Days Ago
Supervisor, Clinical Anesthesia Technical
- Mass General Brigham
-
Boston, MA
FULL_TIME
- General Responsibilities : 1. Oversee the day-to-day clinical activities for Anesthesia technicians in all anesthetizing locations at the MGH main campus including off-site, Lunder, and Legacy locatio...
- 2 Days Ago
Supervisor, Clinical Anesthesia Technical
- Massachusetts General Hospital(MGH)
-
Boston, MA
FULL_TIME
- Supervisor, Clinical Anesthesia Technical - (3287458) General Responsibilities: 1. Oversee the day-to-day clinical activities for Anesthesia technicians in all anesthetizing locations at the MGH main ...
- 3 Days Ago
Supervisor, Clinical Anesthesia Technical
- Massachusetts General Hospital(MGH)
-
Boston, MA
FULL_TIME
- Supervisor, Clinical Anesthesia Technical - (3287458) General Responsibilities: 1. Oversee the day-to-day clinical activities for Anesthesia technicians in all anesthetizing locations at the MGH main ...
- 3 Days Ago
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0 Technical Writing Supervisor jobs found in Framingham, MA area
California residents only, REMOTE, Technical Supervisor of IT Infrastructure (Administrative Focus)
- Prosum
-
Boston, MA
- ONLY FOR CALIFORNIA RESIDENTS. PAY IS W2, not accepting candidates with visa restrictions that require pay in c2c/corp. ...
- 5/1/2024 12:00:00 AM
General Supervisor
- BostonGene
-
Waltham, MA
- About BOSTONGENE: BostonGene Corporation pioneers biomedical software for advanced patient analysis and personalized the...
- 5/1/2024 12:00:00 AM
Technical Supervisor for High Complexity CLIA Lab
- Nanobiosym
-
Cambridge, MA
- Nanobiosym is an innovative company in Cambridge, MA that is developing novel technologies to address a broad range of d...
- 5/1/2024 12:00:00 AM
Supervisor, Technical Operations Engineering, Gas System Operations
- Eversource Energy
-
Southborough, MA
- Role and Scope of Position: Supervises internal and external field work crews and engineering personnel engaged in the d...
- 5/1/2024 12:00:00 AM
California residents only, REMOTE, Technical Supervisor of IT Infrastructure (Administrative Focus)
- Prosum
-
Boston, MA
- ONLY FOR CALIFORNIA RESIDENTS. PAY IS W2, not accepting candidates with visa restrictions that require pay in c2c/corp. ...
- 5/1/2024 12:00:00 AM
Medical Lab Technician - Molecular Diagnostics
- Brigham and Women's Hospital
-
Boston, MA
- Medical Lab Technician Molecular Diagnostics Entry Level ASCP Role We're offering a generous sign on bonus of $10000 com...
- 5/1/2024 12:00:00 AM
Medical Lab Technician - Molecular Diagnostics
- Partners Healthcare System
-
Boston, MA
- Medical Lab Technician Molecular Diagnostics Entry Level ASCP Role We're offering a generous sign on bonus of $10000 com...
- 5/1/2024 12:00:00 AM
Medical Lab Technician, Chemistry
- Brigham & Women's Hospital(BWH)
-
Boston, MA
- Medical Laboratory Technician I Chemistry We're offering a generous sign on bonus of $10000 come you to our team. Recogn...
- 4/29/2024 12:00:00 AM
About Framingham, Massachusetts
Framingham is located at 42°17′59″N 71°25′35″W / 42.29972°N 71.42639°W / 42.29972; -71.42639 (42.299795, −71.426627).
According to the United States Census Bureau, the city has an area of 26.4 square miles (68.5 km²). 25.1 square miles (65.1 km²) of it is land and 1.3 square miles (3.4 km²) of it (4.99%) is water.
Framingham is in eastern Massachusetts, 20 miles (32 km) west of Boston, midway between Boston and Worcester. It is bordered by Southborough and Marlborough on the west; Sherborn and Ashland on the south; Natick on the east; Wayland on the northeast; and Sudbury on the north.
The ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Technical Writing Supervisor jobs
$73,248 to $99,904
Framingham, Massachusetts area prices
were up 2.5% from a year ago
were up 2.5% from a year ago
What does a Technical Writing Supervisor do?
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