Technical Writing Manager jobs in Massachusetts
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.
-
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. - 14 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...
- 14 Days Ago
Career Focused Writing Teacher
- Assabet Valley Regional Technical High School
-
Marlborough, MA
FULL_TIME
- Assabet Valley Regional Technical School has an opening for a Career Focused Writing Teacher Performance Accountabilities: I.Instructional Planning: •Advance student learning through the use of clearl...
- 17 Days Ago
Auditor/Technical Manager (NQ204/2461)
- NATIONAL TECHNICAL SYSTEMS
-
Acton, MA
FULL_TIME
- Responsibilities include but are not limited to: NQA Audit and Auditor Strategy Develop and implement organizational Audit strategy in alignment with operations and organization objectives for all pro...
- 1 Month Ago
Senior Manager, Medical Writing
- Sarepta Therapeutics
-
Cambridge, MA
FULL_TIME
- The Senior Manager of Medical Writing independently develops and delivers timely clinical and regulatory documents. Ensures high quality scientific content, organization, clarity, accuracy, format, co...
- 12 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...
- 25 Days Ago
Technical Writing Manager jobs at Popular Companies
Production Supervisor (AM1)
- CF Industries Employee Services LLC
-
Sergeant Bluff, IA
- At CF Industries, our mission is to provide clean energy to feed and fuel the world sustainably. Our employees are focus...
- 4/25/2024 12:00:00 AM
Marketing Specialist I
- Mediacom Communications Corporation
-
Rantoul, IL
- Position: Marketing Specialist I Who we are: Since 1995, Mediacom Communications has become a coast-to-coast presence wi...
- 4/24/2024 12:00:00 AM
Manager, Environmental, Health & Safety (EHS) – Universal Epic Universe
- Universal Orlando
-
Orlando, FL
- Universal Orlando Resort believes in-person collaboration is key to our success. Many of our Team Members work in a hybr...
- 4/24/2024 12:00:00 AM
Manufacturing Engineer
- SPECTRAFORCE
-
Fremont, CA
- Batch Records Engineer Fremont, CA 94555 (Hybrid – 2 / 3 days per week) 12 Months Minimum Pay Rate: $70/hr on W2 Duties:...
- 4/24/2024 12:00:00 AM
Proposal Coordinator 24-00157
- ESPO Corporation
-
Wallingford, CT
- Job Title: Proposal Coordinator Location: Wallingford, CT Our client, a global Architecture and Design Firm, is looking ...
- 4/24/2024 12:00:00 AM
Senior Site Quality Specialist -24-00147
- ESPO Corporation
-
Panhandle, TX
- Job Title: Senior Site Quality Specialist Location: Panhandle, TX. Job type and Duration: Contract Our client, a global ...
- 4/24/2024 12:00:00 AM
Technical Writing Manager
- Net2source Inc.
-
Fort Worth, TX
- Business Analyst/Technical Writer Ft. Worth, TX Contract to hire Description: Work with PM's. SMEs, and business leads t...
- 4/22/2024 12:00:00 AM
Project Manager
- Tigua Inc.
-
Washington, DC
- Job Description Job Description Position Summary: Tigua Technologies is currently in search of an accomplished Project M...
- 4/20/2024 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 Manager jobs
$126,517 to $162,071
Most Popular Cities in Massachusetts for Technical Writing Manager Jobs
What does a Technical Writing Manager do?
Technical Writing Manager in Lake Charles, LA
Each of these Technical Writing Managers oversees a team of Technical Writers who are embedded in cross-functional, stage group teams.
January 02, 2020
Technical Writing Manager in Madison, WI
Technical writers are expected to bring both broad and deep knowledge, and skilled workers are in high demand.
January 23, 2020
Technical Writing Manager in Sioux Falls, SD
Seeking a Technical Proposal Writer/Editor to join an established firm in the federal defense and mission support arena.
February 18, 2020