Technical Writer II

• The candidate must have excellent Chemistry, Manufacturing and Controls (CMC) technical writing and communication skills with a strong background in pharmaceutical manufacturing, regulatory writing or quality control/quality assurance
• 7 years experience in pharmaceutical manufacturing or development.
• Expertise with MS Office, Word, Excel and Documentum based systems is crucial, experience with Visio Technical is preferred and a working knowledge of cGMPs is desired.
• Product development, process validation and experience with CMC documentation for various dosage forms are necessary.
• A BS/BA degree in Pharmacy, Chemistry, Biology or science is desired.
• This position requires the incumbent to be highly organized, self-motivated, and able to juggle multiple priorities.
• The desired candidate will have the capacity to be productive with very little supervision and enjoy writing.
• Excellent interpersonal communication skills are required.
• Knowledge of the US regulatory processes is necessary and exposure to non-US regulatory activities is desired
• The candidate must have prior experience writing CMC technical reports or CMC regulatory content or Quality Investigations with a demonstrated ability to interact with a multi-disciplined team.
• Experience with standardized templates and familiarity with US and International regulatory submissions is desired.
• The ability to communicate using oral and written skills with an excellent knowledge of the English language and strong proofreading and spelling skills is required.

Skills:

• Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidance; author and compile CMC dossiers for NDA supplements, annual reports, phase IV IND, and DMF annual updates for assigned products in eCTD format.
• Work closely with quality, manufacturing, regulatory and technical staff from global locations and with external contractors to communicate, coordinate and track required documentation in support of new and post-approval CMC regulatory activities.
• Contribute to various projects by planning, writing and delivering agreed submission deliverables for US, EU and rest of world (ROW) registrations.
• Author and create dossier content from source documentation as needed for registrations and provide writing support for technical reports.
• Recommend table of contents for regulatory submissions.
• Develop and contribute to regulatory strategy for successful product registration.
• Provide and write answers to questions received from health authorities.
• Create and author dossiers for re-registrations.
• Ensure all dossiers are in compliance with appropriate SOPs, guidances, GXP and ICH guidances and maintain up to date knowledge.
• Communicate with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions.
• Develop and maintain skills required for dossier related software systems used and included in regulatory filings

Education:

• 3 plus years experience in a pharmaceutical environment
• 4+ years of experience with CMC regulatory related activities.
• BS/BA or MS or PhD from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).

Experience:

• Experienced with change control systems, and authoring and reviewing FDA post-approval CMC changes requiring eCTD format for submissions.
• Worked with multi-disciplined teams in the bio-pharmaceutical industry and with internal and external partners.
• Excellent technical writing and communication skills, attention to detail and formatting.
• Inform management in advance of barriers to meeting deadlines.
• In-depth knowledge of USP/Eu. Ph. and Code of Federal Regulations (CFR).
• Working knowledge of cGMPs
• Worked with writing template tools, Documentum based or similar systems

Responsibilities for the Technical Writer• Monitors the project life cycle, updates the URS, if needed, generates the functional requirements specifications (FRS), and based on the final design, generates the machine acceptance documents (FAT/SAT).
• Manage library of support documents and interface with the Quality department to ensure compliance to CPT and GAMP requirements.
• Research and translate technical information into manuals for nontechnical users. Verify document content on actual machine, confirming actions and responses are correct.

Requirements for the Technical Writer

• Associate”s degree and 5 years of dedicated Technical Writing in a “High” technology setting.
• Experience with GAMP and/or documentation of new equipment builds and installation in a manufacturing environment.
• Should be familiar with process automation equipment, including HMI”s, PC interfaces, and instrumentation used to operate a large manufacturing process machine.

Benefits

• Health Insurance
• 401k

Principal Medical Writer

Cambridge, MA

Contract

The Principal Medical Writer will be responsible for managing medical writing vendor(s), documents, and reviews for clinical and regulatory documents (protocol, CSR, IB, clinical sections clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format.

· Must Understand CSR development and Writing

· 7+ years of experience and prior experience as a Lead

· End to end clinical trial experience ( they will be working across different studies) NDAs and INDs

The successful candidate will be an independent, proactive, experienced medical writer with experience in preparing key summary submission documents (eg, Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview), and demonstrated experience managing the project work of other outsourced medical writers.

Job Title: Manufacturing Engineering Technical Writer

Duration: 9+ Months

Location:  Big Flats, NY

Description:

•  Capital Project Technical Writer – Support the Design, Acceptance, Installation, and Validation of Large Scale Manufacturing Process Equipment, per GAMP (good automated manufacturing practices).

• At the beginning of the capital project, gathers and compiles equipment design requirements to generate the user requirements specification (URS).

• Monitors the project life cycle, updates the URS, if needed, generates the functional requirements specifications (FRS), and based on the final design, generates the machine acceptance documents (FAT/SAT).

• During equipment installation, creates, writes, and edits operational, instructional, and maintenance documents required for the operation and support of the process and process equipment.

• Conducts interviews with users and technical staff to gather data for documentation. Researches and translates technical information into manuals for nontechnical users.

• Verifies document content on actual machine, confirming actions and responses are correct.

• Manages library of support documents and interfaces with the Quality department to ensure compliance to CPT and GAMP requirements.

• Produces products that conform to the company documentation and quality assurance standards.

• Utilizes existing templates and recommends format improvements to meet technical and customer requirements.

• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

• Exercises judgment within defined procedures and practices to determine appropriate action. Has internal and external contacts.

The candidate should have experience with GAMP and/or documentation of new equipment builds and installation in a manufacturing environment.

Should be familiar with process automation equipment, including HMI”s, PC interfaces, and instrumentation used to operate a large manufacturing process machine.

PPE: Standard will be provided (Rx Safety glasses will not be reimbursable)

Education: AAS Required.

Experience: 5+ years of dedicated Technical Writing in a “High” technology setting 

RESPONSIBILITIES:

Kforce has a client in search of a Technical Writer in Andover, Massachusetts (MA). Technical Writing role writes, or supports the development of, various technical documents such as: requirements, specifications, test plans, and user manuals.

Major Role Responsibilities:

• Understands validation concepts in order to produce documentation for validated systems
• Provides evidence of compliance with legal, business, and regulatory requirements
• Translates highly technical software functions/features into process driven user friendly materials to support implementation and training of applications
• Liaises with clients or developers to gather information
• Organizes, synthesizes medical and business literature, and writes clear, accurate reviews of the literature
• Creates operational and system qualification documentation in support of Messaging Services implementation
• Develops Standard Operating Procedures (SOPs), training materials, and user manuals

REQUIREMENTS:

• BS degree in English, Education, Science, or Engineering
• Biotech background is a must, Biotech terminology, Biotech education
• 1-2 years of work experience
• Must have strong documentation
• Ability to use Microsoft Word
• Detail oriented, work independently, manage their own timeline and deliverable

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

RESPONSIBILITIES:

Kforce has a client in the Holland, Michigan (MI) job market who is seeking an experienced IT Communications Writer. This role is a long-term contracting need.

Summary:
This position will focus on creating a variety of Information Technology internal communication documents including – Bulletins, Newsletters, Advisories, etc. The IT Communications Writer will review Technical Notices, Security Warnings, User Awareness Updates, and other documents and then create interesting and engaging Business Communications from them. The candidate should have a strong writing background and have experience producing Corporate Communication documents that are engaging and informative. The goal for these communications are to update and educate a variety of functional business users about various Information Technology topics. A portfolio of examples of previous work in creating internal Business Communication collateral will be required to be considered.

REQUIREMENTS:

• Bachelor”s degree related to Business/Technical Communications
• 3-5 years of minimum experience creating business communication documents in a large-scale corporate environment
• Experience creating Technology focused newsletters and bulletins
• Experienced creating documents targeted to various functional end-user audiences, i.e. Accounting, Human Resources, Manufacturing, Shipping/Receiving, Production, etc.
• Microsoft Office experience

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Title: Technical Writer- Junior

Location: Durham, NC 27709

Job Summary

Client requires the services of a technical writer with IT technical writing background and experience.

Job Description:

•The primary purpose of this position is to provide technical writing and documentation support for the (client) Program. Documentation support includes, but is not limited to:

•Process and procedure development, functional and detailed design development, federal and state project document deliverables, software design development life cycle documentation, maintenance of project plans, status reports, user manual or help sheets, meeting agendas and minutes and various other technical and functional documents.

•The position will support technical business analysis, system architecture and infrastructure design, configuration management, project planning/tracking, definition and validation of business, functional, and technical requirements, and system implementation.

•Tasks to accomplish these objectives include organizing and maintaining inventory of various project documents, administration and tracking project deliverables, communicating with internal and external clients, timely communication to project team management on any potential issues, and communicating and consulting within Division, project stakeholders and within the client technical community.

•This position must communicate processes and procedures to representatives with varied skill sets (business staff, technicians, managers, etc.) and demonstrate outstanding written communication skills.

•This position must ensure standards and procedures are applied to all project deliverables, proper methodology is used, and a high quality product is provided to client agencies.

•This position will also assist the Project Manager and project staff in scheduling, preparing for and participating in QA reviews.

About our Company: –

Connecting people’s aptitude & ambitions with our opportunities to deliver results.

E-Talent Network is responsible for carrying out the recruitment process and is a service provider for 22nd Century Technologies. 

22nd Century Technologies was established in 1997 and is headquartered in McLean VA. We are one of the leading IT services and solutions firm in the country with 12 regional offices and presence in all 50 states. We bring a mix of innovative technology and sector expertise to customers in defense, intelligence, civil, and healthcare markets. As our name implies, we are a forward thinking company with the ultimate goal of helping our customers implement innovative IT solutions that will satisfy their business needs. We combine real-world experience, specialized skills, innovative thinking, and industry knowledge to deliver quality IT solutions. At our core, we are about people – our customers and our employees.

“22nd Century Technologies is an Equal Opportunity Employer” and “US Citizens & all other parties authorized to work in the US are encouraged to apply.”

The Senior Proposal Writer leads content creation and delivery of on-time, high-quality proposals. S/he researches, formats and writes compelling and persuasive proposals in a manner that will produce competitive, strategic responses to bid requests. Primary focus / responsibility is for non-competitive (sole source) responses to state, local, and commercial requests.

DUTIES & RESPONSIBILITIES

• Manage response efforts for client requests (sole source quotes), including but not limited to, scheduling key project dates; editing written content in alignment with company-developed strategy and messaging; designing content layout; developing graphic components (org charts, tables, etc.); and producing and coordinating delivery of all final products
• Provide supporting role to Principal and Sr. Proposal writers with competitive (RFI, RFP, RFQ, ITB, BAFO) proposals when requested
• Understand RFP requirements and provide content to ensure compliance with the RFP instructions and responsiveness to the evaluation criteria
• Identify potential issues in the proposal development stage and escalate concerns to stakeholders, including executive management
• Ensure that each assigned proposal is well written, persuasive, and 100% compliant with the Quote Request or RFP requirements, and that information is communicated clearly, accurately, and in a visually appealing manner while in alignment with the company”s overall brand and messaging guidelines
• Manage multiple tasks and concurrent projects simultaneously while meeting company commitments including tight deadlines, quality goals, budget requirements, and customer expectations
• Coordinate with organization-wide resources (e.g., engineering, project management, legal, finance, HR, purchasing, contracts, facilities, etc.) to support proposal efforts and ensure accuracy
• Maintain current knowledge of relevant policies, procedures, and practices involved in proposal development
• Participate in relevant training opportunities that will enhance both individual performance and overall unit performance
• Develop new ideas and creative ways to enhance proposal and presentation products, and drive customer engagement
• Contribute to and help maintain accuracy of boilerplate graphics and language

SUPERVISION REQUIRED

The Senior Proposal Writer, works under the supervision of the Manager or Sr. Manager of Proposals, on all assigned projects.

SUPERVISORY RESPONSIBILITIES

The person in this position does not supervise other employees.

Required Skills:

REQUIRED SKILLS AND QUALIFICATIONS

• Must have a Bachelor”s degree in Business, Communications, Marketing, Public Relations, Journalism, English, or related field
• Must have a minimum of three years of experience in proposal writing, technical writing, or related field
• Must have two to five years of experience in a NORAM company and be familiar with one or more NORAM product lines
• Must be able to analyze customer requirements to determine proposal response needs and ensure responses are in compliance
• Must be able to demonstrate the ability to work with technical subject matter experts, assisting them through the storyboard / annotated outline process, and translating their technical content/ideas into understandable language
• Must be able to work under pressure and meet deadlines in a dynamic and fast-paced environment
• Must be a self-starter able to work both independently and as a team player with a diverse population
• Must be able to work collaboratively as a member of a virtual project team
• Must have excellent writing and editing skills
• Must have excellent problem solving skills
• Must have excellent organizational and prioritization skills
• Must have solid communication skills
• Must have good strategic, analytical, and critical thinking skills
• Must have excellent computer skills (MS Office Suite, Visio, Project, SharePoint, Content Management, etc.)

DESIRABLE SKILLS AND QUALIFICATIONS

• Master”s degree Business, Communications, Marketing, Public Relations, Journalism, English or related field; background in Engineering or technical field a plus
• Experience in proposal writing, technical writing, or related field in a contracting environment, especially for state, local, and federal government agencies with a primary focus being non-competitive sole source proposals
• Government bidding experience, including an understanding of the proposal development lifecycle, government procurement process / regulations, capture planning, facilitation of theme development, proposal generation, and production
• Knowledge of desktop publishing and editing
• Knowledgeable about NORAM customers, with direct interaction a plus
• Knowledge of Association of Proposal Management Professionals (APMP) principles and guidelines
• Experience using Content Management systems; experience with Qvidian a plus
• Expert level skills in presenting content via word processing (e.g., MS Word) or page layout (e.g., Adobe InDesign, PhotoShop) tools
• Graphic design experience a plus
• Prior experience with criminal justice information system and/or biometric technologies, or other complicated IT network system solutions

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is required to sit for prolonged periods of time and use their hands and fingers while typing. The employee is occasionally required to stand and walk. Vision abilities required by this job include close vision to the screen. Ability to focus, analyze, and assess information, while negotiating with other team members to arrive at the best response to the customer.

Required Experience:

Travel Requirement, Working Conditions and Physical Demands:

Travel Requirement, such as;

• Ability and willingness to travel as needed.

Working Conditions, such as:

• General office environment. The work area is adequately lighted, heated, and ventilated.

Physical Demands, such as:

• Office environment where the employee may sit comfortably to do the work. Some walking, standing, bending, reaching, and carrying of light items such as papers, books, small parts; driving an automobile, etc. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, and other office equipment.

Must be eligible to work in the United States

IDEMIA is an equal opportunity employer.

We evaluate qualified applicants without regard to race, color, religion, sex,

sexual orientation, gender identity, national origin, disability, veteran status, and other protected characteristics

PI101694105

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