Technical Writing Director jobs in Pennsylvania
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)
Recently Added Technical Writing Director jobs
Associate Director Medical Writing
- Aequor
-
King of Prussia, PA
FULL_TIME
-
100% remote
The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more Programs within Clinical Development.
You will be accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of clinical programs. They are responsible for the messaging strategy across a program of work, for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency.
This role can have global responsibilities with participation in global teams and interaction with regulatory agencies in multiple regions.- This role reports to the Director of Medical Writing
- Maintain a collaborative and strategic partnership with, Global Clinical Program Directors and Clinical Safety Physicians to ensure understanding of Clinical Development strategy for the Program.
- Leads cross-functional teams to develop a messaging strategy across a program of work (e.g., building a clinical submission)
- The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines
- Resource planning and resource allocation.
- Project Manage Medical Writer(s) within the Program. Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work
- Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (i.e., regulatory submission or publication of key journal articles for a publication plan).
- Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinical Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.
- Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency.
- Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.
- Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
- Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
- Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards.
- Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
- Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
- Responsible for continual improvement of in-house medical writing.
- Provides expert medical writing support to other CR&D and CSL groups where required.
- In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs including forecasting, budgeting, resource planning and resource allocation
- Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc.) to ensure an effective, efficient, productive and professional working relationship. Participates in vendor governance.
- Participant in bid defense, contract development, work alignment and / or operation meetings.
Education
Bachelor's Degree minimum requirement
Experience
Post-graduate qualifications, preferred- A minimum of 5 years medical writing experience within the biopharmaceutical industry or a contract research organization.
- A comprehensive understanding of the clinical development process, including the documents that are required at each stage.
- A comprehensive understanding of medical writing processes, standards and issues.
- Demonstrated track record in cross-functional, multicultural and international clinical trial teams.
- Excellent verbal, written and presentation skills.
- Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
- Prior experience with submissions in Common Technical Document (CTD) format.
- Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
- Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
Competencies- Ability to think strategically; demonstrated negotiating skills and resourcefulness.
- Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
- Strong influencing skills, able to lead without formal authority.
- Strong interpersonal skills; proven track record of staff management and effective leadership.
- Demonstrated ability to drive performance - holds others accountable for high standards and clarifies what needs to be accomplished and the consequences for the individual and / or organization.
- Demonstrated ability to manage several projects simultaneously.
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas.
- High degree of influencing skills in shaping and developing content and wording.
- Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions / proposals.
- Successful track record of leading complex clinical / regulatory writing projects.
- Can manage uncertainty and shifting priorities and timelines.
- Demonstrates learning agility.
- An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP).
- Excellent organizational and time management skills.
- Attention to detail.
- This role reports to the Director of Medical Writing
- 2 Days Ago
Senior Director, Medical Writing
- Harmony Biosciences
-
Plymouth Meeting, PA
FULL_TIME
- Harmony Biosciences is recruiting for a Senior Director, Medical Writing in our Plymouth Meeting, PA location. In this role you will be accountable for the timely preparation of high-quality regulator...
- 3 Days Ago
Senior Director of Medical Writing
- Larimar Therapeutics Inc
-
Bala Cynwyd, PA
FULL_TIME
- DescriptionThe Company:Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its no...
- 9 Days Ago
Associate Director of Medical Writing
- IPG Health
-
Radnor, PA
FULL_TIME
- CMC Connect, part of McCann Health, is a leading global medical communications agency established 25 years ago. We have UK-based offices in Glasgow, Macclesfield and Manchester, and a US-based office ...
- 2 Months Ago
Technical Content Writing Intern/Freelancer (Remote)
- NextBillion.ai
-
Indiana, PA
INTERN
- Duration: 4-6 monthsCompany Overview: NextBillion.ai is a Location Technology and Mapping Services provider. We are seeking a talented and motivated Technical Content Writing Intern/Freelancer to join...
- 15 Days Ago
Executive Director
- Berks Technical Institute
-
Wyomissing, PA
FULL_TIME
- Formally apply at www.ancora.com/careers and search Wyomissing Ancora offers relocation assistance, an extensive benefits package, including 401(k), after 30 days of full-time employment, and 2 weeks ...
- 2 Months Ago
Technical Writing Director jobs at Popular Companies
Technical Director
- Department of Homeland Security
-
Arlington, VA
- The Department of Homeland Security (DHS) is recruiting for a Technical Director to serve as an executive within the Cyb...
- 6/2/2024 12:00:00 AM
Technical Director
- Department of Homeland Security
-
Arlington, VA
- The Department of Homeland Security (DHS) is recruiting for a Technical Director to serve as an executive within the Cyb...
- 6/2/2024 12:00:00 AM
Technical Director
- Hubbard Broadcasting
-
Duluth, MN
- About Us WDIO-TV, News Channel 10/13 is the award-winning ABC network affiliate for Northeastern Minnesota and Northwest...
- 6/1/2024 12:00:00 AM
Technical Director
- Lam Research Corporation
-
Fremont, CA
- The Group You'll Be A Part Of Customer Service Business Group Engineering The Impact You'll Make Responsibilities will i...
- 6/1/2024 12:00:00 AM
Technical Director
- The Chatham Group
-
Columbia, SC
- Job Description Job Description Title: Technical Director Location: Columbia, SC area Overview The Chatham Group is a ...
- 5/31/2024 12:00:00 AM
Technical Director
- Lynn University
-
Boca Raton, FL
- Summary: Lynn University seeks an experienced performing arts Technical Director for the Wold Performing Arts Center and...
- 5/29/2024 12:00:00 AM
Technical Director
- Faith Family Church
-
Baytown, TX
- Job Description Job Description Salary: Position Title: Technical Director Reports To: Creative Director / IT Position H...
- 5/29/2024 12:00:00 AM
Technical Director
- Zolo Broadcasting
-
Bend, OR
- As Technical Director, you will be responsible for executing a wide range of video production tasks that include directi...
- 5/7/2024 12:00:00 AM
About Pennsylvania
Pennsylvania (/ˌpɛnsɪlˈveɪniə/ (listen) PEN-sil-VAY-nee-ə), officially the Commonwealth of Pennsylvania, is a state located in the northeastern and Mid-Atlantic regions of the United States. The Appalachian Mountains run through its middle. The Commonwealth is bordered by Delaware to the southeast, Maryland to the south, West Virginia to the southwest, Ohio to the west, Lake Erie and the Canadian province of Ontario to the northwest, New York to the north, and New Jersey to the east.
Pennsylvania is the 33rd-largest state by area, and the 6th-most populous state according to the most recent of...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Technical Writing Director jobs
$164,046 to $204,276
Most Popular Cities in Pennsylvania for Technical Writing Director Jobs
What does a Technical Writing Director do?
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