Technical Writer

Alta Resources is Hiring!

Summary

The Technical Writer creates, updates, and maintains standard operating procedure documents including but not limited to team operations, training specific exercise materials, and customized workflow training. This person must have excellent research skill and must be able to organize his/her ideas and translate technical terms into text that any reader can understand. In doing so, he or she ensures that all material is documented with high readability and quality.

Essential Duties & Responsibility

Other duties may be assigned.

• Review and monitor any operational documents to ensure they are written properly and follow all standards.

• Work with the analysts or end users in the collection of requirements and visit with the users to understand how they do the job currently and write documents to match all requirements.

• Work with training team to put together class materials, CBTs, demos, and other training materials.

• Periodically provide classroom training as backup to Trainers.

• Write communication for product or team announcements, marketing brochures, adverts, and marketing specifications.

• Develop and implement evaluation instruments for training modules and provide training evaluation results, recommendations, and action plans for Team Leaders and designated client staff.

• Formulate process outlines and determine implementation methods such as individual training, lectures, demonstrations, conferences, meetings, and workshops.

• Confer with client and Alta Lead Trainer to gain knowledge of work situations requiring training for employees to better understand changes in policies, procedures, regulations, technologies, or the general improvement in customer service abilities.

• Confer with Compliance team, Training Team and Alta Leaders to determine training and documentation needs.

• Evaluate current procedures, developing and documenting process changes and creating training for new programs and procedures.

• Assess status of Work Instructions, policy and procedure changes coming in daily across multiple channels.

• Recommend training and develop appropriate documentation based on how procedures are or are not currently documented and follow training through to the end users.

• Anticipate how process changes affect team, mitigate risk and address potential problem areas, re-evaluate and recommend retraining to Training Team Leader to close gaps and minimize compliance concerns.

• Create, revise, and review SOPs, WIs, Information Alerts, other training (e.g. workbooks) based on internal and external requests and training needs

• Maintain accurate and quality Training Team standards and anticipate and correct gaps.

• Create training and document processes in response to audit findings, client requests, new policies, programs and product changes, continuing education training requests and other training needs and recommendations.

• Support Training Team Inbox, answering training questions and assess ongoing requests and training needs.

• Adhere to applicable Program, Client and Corporate policies, procedures and work instructions. Manage Consumer/Health Care Professional/Regulatory contacts relating to US and/or Canadian drug, medical device, cosmetic and/or dietary supplement products and/or their proper use, contraindications, adverse events/complaints, formulation, distribution and/or recall.

• Accurately assess issues and, based on analysis, assign adverse event/product quality pharmacovigilance subject code(s) to conform to Client, U.S. Food and Drug Administration (FDA), Health Canada and MedWatch pharmacovigilance reporting standards and regulations.

• Apply good documentation principles conforming to U.S. FDA’s 21 CFR 210, 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP) and 21 CFR 820 Quality System Regulation to clearly and accurately record contact/product data, contact verbatim, medical information, pharmacovigilance subject codes, and dates/reasons for any changes in proper database/paper locations to support Client reporting to regulatory authorities.

• Escalate critical issues to designated management representatives.

• Handle and protect individually identifiable health information in accordance with HIPAA and similar security/privacy regulations and standards.

• Support duties for Quality/Oversight/Audit as follows:

• Respond to questions from auditors/government inspectors in professional,

• factual manner.

• Provide assistance for audit preparation and/or audit/inspection support as may be requested by management.

• Manage work with a view to continuous quality improvement. Promptly notify Team Leader or subject matter expert with any questions about how or if a task should be performed.

• Immediately notify supervisor and Quality/Compliance team about any potential nonconformance.

• Event Support (e.g., Product Recall, major media news)

• Schedules: Quickly adjust schedules and work extended hours necessary to support event.

• Training: Complete training and understand new information related to the event subject in short period of time.

• Regular attendance, punctuality and adherence to agreed-upon schedule of availability are conditions of employment and essential function of this position.

Leadership Responsibilities

Although this position will not have responsibility for direct reports, the position requires active leadership in the way of supporting strategic initiatives as well as active personal development and application of Six Sigma methodologies.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Strong interpersonal and communication skills.

• Strong analytical ability to develop strategy, policies, and procedures.

• Strong attention to detail.

• Excellent writing skills.

• Must demonstrate good listening, problem solving, and decision-making abilities.

• Exercises good judgment. Knows when to involve supervisors.

• Highly self-motivated with the ability to prioritize and execute tasks.

• Must have the proven ability to work independently and deliver results in a fast-paced environment.

• Have strong attention to detail and accuracy.

• Ability to function in a team environment and embrace change.

• Strong computer and data-entry skills. Proficiency in typing/keyboarding.

• Must demonstrate a friendly, professional manner. Sets the example for peers.

• Must have a willingness and ability to establish and maintain strong knowledge on client products and other services.

• Willingness to work flexible hours as needed.

• Strong work ethic/committed to the job/program.

• Flexibility, ability to meet deadlines.

• Complete all required training by deadlines.

• Demonstrate applied competency in quality/compliance standards and applicable Program, Client and Corporate policies, procedures and work instructions though appropriate and timely analysis, decision-making, communication and recordkeeping.

• Successfully complete all Certification program(s) that apply to assigned role(s).

EDUCATION and/or EXPERIENCE

Bachelor's degree (B. A.) from a four-year College or University and three years of relevant technical writing experience is required. Experience with document management preferred. Experience with proper Standard Operating Procedures and Work Instruction formatting rules and guidelines needed.

TECHNOLOGY SKILL BASE

This position requires a working knowledge of computer technology that includes: Intermediate to advanced Microsoft Word, PowerPoint, Excel, and Outlook. Knowledge of Lotus Call Quality Software. Individuals in this position must possess the ability to learn and understand new software and other technology applications as introduced by Client and Alta Resources.

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Individuals in this position must have strong written and oral communication skills.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, percents, and decimals. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

Work Environment

Alta Resources is an equal employment opportunity employer.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Due to the nature of this work individuals may be required to be on-sight during hours designated by the Client, however, the occasion will arise when the employee must be off-site due to business functions.

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