Technical Writing Manager jobs in Boston, MA
Technical Writing Manager manages and reviews the work of supervisors and a group of technical writers. Ensures standard documentation methods are followed by staffs. Being a Technical Writing Manager provides guidance on writing very complex technical documentations. Requires a bachelor's degree. Additionally, Technical Writing Manager typically reports to a senior manager. The Technical Writing Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Technical Writing Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Recently Added Technical Writing Manager 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. - 15 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...
- 15 Days Ago
Senior Manager, Medical Writing
- Moderna
-
Cambridge, MA
FULL_TIME
- The Role:The Senior Manager of Medical Writing is a high-impact role, reporting directly to the Associate Director, Director of Medical Writing, or Senior Director of Medical Writing. The chosen indiv...
- 26 Days Ago
Senior Manager, Scientific Writing
- Kiniksa Pharmaceuticals
-
Lexington, MA
FULL_TIME
- Reporting to the Director, Scientific Communications, the Senior Manager, Scientific Writing will be responsible for assisting in the development and execution of the medical and scientific communicat...
- 1 Month Ago
Manager/Senior Manager, Medical Writing
- 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...
- 15 Days Ago
Sr. Manager, Medical Writing - Delivery & Excellence
- Moderna
-
Cambridge, MA
FULL_TIME
- The Role:The Senior Manager of Medical Writing Delivery & Excellence is a high-impact role that demands a dynamic blend of expertise in both traditional medical writing and technological innovation. R...
- 14 Days Ago
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0 Technical Writing Manager jobs found in Boston, MA area
Director, eCommerce Technology
- Life is Good
-
Boston, MA
- Hey, trailblazer. What have you done lately that made you proud? Remember the thrill of accomplishment that comes when y...
- 4/26/2024 12:00:00 AM
Executive Director
- The Record Co.
-
Boston, MA
- THE OPPORTUNITY The Record Co. seeks an Executive Director to lead and help shape our organization's future. The ideal c...
- 4/26/2024 12:00:00 AM
Senior Scientist / Team Leader - Small Molecule , Method Development , HPLC , GMP
- Ichgcp
-
Boston, MA
- **Senior Scientist / Team Leader - Small Molecule , Method Development , HPLC , GMP** **Pharmaceutical Product Developme...
- 4/26/2024 12:00:00 AM
National Project Coordinator - Friedman School of Nutrition
- Tufts University
-
Boston, MA
- Overview: New Entry Sustainable Farming Project (New Entry) improves our local and regional food systems by training the...
- 4/25/2024 12:00:00 AM
Director of Grants
- The Possible Zone
-
Boston, MA
- DIRECTOR OF GRANTS THE POSSIBLE ZONE BOSTON, MA Exempt, Full Time The Possible Zone (TPZ), a nonprofit organization, see...
- 4/25/2024 12:00:00 AM
Tech Advisory and Delivery Manager
- Boston Consulting Group
-
Boston, MA
- Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challeng...
- 4/25/2024 12:00:00 AM
Project Manager
- Medasource
-
Boston, MA
- Position: Project Manager Location: Boston, MA (Hybrid) Duration: 6 Month Contract to Hire Job Description: The Cardiac ...
- 4/24/2024 12:00:00 AM
Business Area Director
- Boston Fusion
-
Boston, MA
- At Boston Fusion, we recognize diversity is the catalyst for limitless creativity. As a Business Area Director at Boston...
- 4/24/2024 12:00:00 AM
About Boston, Massachusetts
Boston has an area of 89.63 square miles (232.1 km2)—48.4 square miles (125.4 km2) (54%) of land and 41.2 square miles (106.7 km2) (46%) of water. The city's official elevation, as measured at Logan International Airport, is 19 ft (5.8 m) above sea level. The highest point in Boston is Bellevue Hill at 330 feet (100 m) above sea level, and the lowest point is at sea level. Situated onshore of the Atlantic Ocean, Boston is the only state capital in the contiguous United States with an oceanic shoreline.
Boston is surrounded by the "Greater Boston" region and is contiguously bordered by the citi...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Technical Writing Manager jobs
$130,354 to $166,987
Boston, Massachusetts area prices
were up 2.5% from a year ago
were up 2.5% from a year ago
What does a Technical Writing Manager do?
Technical Writing Manager in Alamogordo, NM
In information technology, project managers and analysts write technical documents that must be clear and concise.
December 17, 2019
Some project teams have the luxury of having professional technical writers on staff but most project teams are not as fortunate.
January 25, 2020
Technical Writing Manager in Kingsport, TN
We are looking for a Technical Writer to join our team helping to defend our customers from threats globally.
January 28, 2020
Technical Writing Manager in Petaluma, CA
We are able to understand the holistic scope of our clients’ needs and, from that, provide a business solution, not just a technical document; making it easier to solve business challenges.
February 07, 2020