Technical Writing Director jobs in Massachusetts

Technical Writing Director establishes and plans the overall policies and goals for technical writing function. Develops standard documentation methods to effectively communicate product concepts and technical information. Being a Technical Writing Director coordinates with other teams and departments to determine technical writing needs. Requires a bachelor's degree. Additionally, Technical Writing Director typically reports to a senior manager or top management. The Technical Writing Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. To be a Technical Writing Director typically requires 3+ years of managerial experience. (Copyright 2024 Salary.com)

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Director, Medical Writing - 2437
  • Editas Medicine
  • Cambridge, MA FULL_TIME
  • At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

    We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

    Together, we are leading the way towards a healthier and more equitable future.

    The Head of Medical Writing (Sr Director), Medical Writing will work collaboratively with Editas clinical development, operations,  regulatory, statistics and data management teams to produce high quality documents to support the company’s drug development programs. This role is responsible for developing and implementing processes and standards to ensure company documentation is prepared to the highest editorial standards and quality and to ensure compliance with regulatory guidance. This person will be responsible for leading a team of contract medical writers in helping the company to achieve corporate objectives. This position reports to the VP of Clinical Operations.

    Key responsibilities:
    Responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of a clinical program

    • Advanced knowledge of IND/BLA submissions and working knowledge of and experience in document management systems
    • Develop, align, coordinate, and build consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continue through study level documents to final program level deliverables (i.e., regulatory submission, preparation of clinical study reports, or publications [as requested and agreed to])
    • Advise on strategic document development, ensuring adherence to regulations, ICH guidelines, and standard operating procedures (SOPs)
    • Define and oversee all clinical writing activities with cross functional alignment on timing, content and stakeholders
    • Leads a team of contract medical writers to ensure the delivery of on time, high-quality work
    • Responsible for implementing and overseeing contract medical writing budget
    • Willing to write documents
    • Coordinate preparation, editing, and finalizing protocols, investigator brochures, synopses, clinical study reports, regulatory documents (BLA, annual reports, orphan drug designation applications, agency response to questions, briefing books, etc.)
    • Collaborate with the clinical and scientific staff for narrative and data presentation planning, gather material for relevant documents and ensure that documents accurately reflect sources
    • Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
    • Ensure documentation conforms to ICH and other relevant regulatory guidelines and medical editorial boards
    • Develops and implements processes and standards to ensure high quality document output and to ensure compliance with regulatory guidance.
    • Hybrid position, on site 2-3 days per week

    Educational requirements:

    • Master’s degree in medical-related field or life science required; (PhD) preferred

    Experience and skill requirement:

    • 15 years’ experience in a medical writing capacity within drug development
    • Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs
    • Previous experience managing direct reports is that includes mentoring, training, and developing staff
    • Thorough knowledge of clinical research concepts, practices, and FDA/EMA regulations and ICH/GCP Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
    • Experience working with CROs, vendors, and relationship management. Experience interacting and communicating timeline expectations with cross functional study team members
    • Expert ability to interpret internal/external business challenges and develop best practices to improve process and services
    • Exceptional ability to communicate highly complex ideas, anticipate potential objections, interact with senior leaders, and apply advance negotiation skills
    • Experience with electronic document management systems
    • Highly proficient in the functionality of MS Word, Excel, Endnote, Adobe Acrobat, and PowerPoint
    • Familiarity with statistical analysis concepts and techniques

    Benefits Summary:

    Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.

    If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.

    Fostering Belonging. Fueling Innovation. Transforming Lives.

  • 18 Days Ago

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Executive Director, Medical Writing
  • Replimune, Inc.
  • Woburn, MA FULL_TIME
  • Overview Summary of job description: The Executive Director, Medical Writing will work collaboratively with Replimune’s regulatory, clinical, and scientific teams to produce high quality documents to ...
  • 19 Days Ago

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Director, Medical Writing
  • Moderna
  • Cambridge, MA FULL_TIME
  • The Role:Reporting directly to the Senior Director or Executive Director of Medical Writing, this pivotal role carries the significant responsibility of ensuring the delivery of high-quality clinical ...
  • 21 Days Ago

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Associate Director, Medical Writing
  • Nuvalent, Inc.
  • Cambridge, MA FULL_TIME
  • The Role: Nuvalent is seeking a highly-motivated, results-oriented team member to join our growing organization as Associate Director, Medical Writing. This role, which will report to the VP, Clinical...
  • Just Posted

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Associate Director, Medical Writing
  • Relay Therapeutics
  • Cambridge, MA FULL_TIME
  • The Medical Writing Lead is responsible for authoring routine clinical and regulatory documents and represents Medical Writing as a cross-functional team member for clinical study level activities. Th...
  • 4 Days Ago

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Senior Director, Medical Writing
  • Dianthus Therapeutics
  • Waltham, MA FULL_TIME
  • About Us Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and...
  • 5 Days Ago

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Technical Director
  • Univision Communications, Inc.
  • Teaneck, NJ
  • The Local New York Operations team at TelevisaUnivision in Teaneck, NJ is looking for an APC Technical Director to join ...
  • 3/28/2024 12:00:00 AM

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Technical Director
  • NetApp, Inc.
  • San Jose, CA
  • About NetApp We're forward-thinking technology people with heart. We make our own rules, drive our own opportunities, an...
  • 3/27/2024 12:00:00 AM

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Technical Director
  • University of California Berkeley
  • Berkeley, CA
  • About Berkeley At the University of California, Berkeley, we are committed to creating a community that fosters equity o...
  • 3/27/2024 12:00:00 AM

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Technical Director
  • Precision Castparts
  • Huntington, WV
  • Country 1 United States of America State / County 1 West Virginia City 1 Huntington Division 1 Energy Company 1 HBE Func...
  • 3/27/2024 12:00:00 AM

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Technical Director (Project)
  • RUN Studios
  • Redmond, WA
  • Description Since 2007, RUN Studios has created world-class creative content for prominent and emerging brands, bringing...
  • 3/27/2024 12:00:00 AM

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Technical Director Quality
  • MKS Instruments
  • Irvine, CA
  • Spectra-Physics, Ophir, Newport and ESI are brands within the MKS Instruments Photonics Solutions division. We provide a...
  • 3/27/2024 12:00:00 AM

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Technical Director / Editor
  • Cascade Hills Church
  • Columbus, GA
  • Job Description Job Description Cascade Hills Church in Columbus, Georgia is seeking an experienced Technical Director a...
  • 3/27/2024 12:00:00 AM

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Associate Technical Director
  • Gearbox Software
  • Frisco, TX
  • Associate Mobile Technical Director, Publishing Responsibilities: * Guide multiple teams through the mobile game develop...
  • 3/25/2024 12:00:00 AM

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 Director jobs
$177,996 to $221,649

Technical Writing Director in Rockford, IL
Even though engineers are technical people, that doesn’t necessarily mean they are good technical writers.
January 10, 2020
Technical Writing Director in Wilmington, DE
Even in technical writing there is no excuse for that.
January 25, 2020
Technical Writing Director in Bradenton, FL
For example, a technical writing department may be expected to manage documentation and is necessary for process control, but you can add commitment to best-in-class performance, which communicates significance, to your writers and others.
December 21, 2019