Writer job description

Job Title
Investigational Writer - First Shift

Requisition

JR000012627 Investigational Writer - First Shift (Open)

Location

Hobart, NY (Pharma) - USA036

Additional Locations

Job Description

SummaryLeads and writes in-depth technical investigations of product quality and equipment related events to determine scope of impact, root cause, corrective actions and rationale to support product disposition. Utilizes root cause analysis tools and lean principles to determine root cause and corrective actions. This is an independent role with progressive responsibilities. Individuals are expected to perform the necessary functions of the role with minimal oversight.Essential FunctionsCollaborate with All Levels of the Organization Works with operators, engineers, subject matter experts, maintenance, supervisors, senior managers, etc., to form in-depth understanding of complex processes, procedures, equipment and event details. Collaborates with Quality Assurance, Validation, and various other departments for events which may potentially affect the safety, integrity, strength, purity, quality, or validated state of the product, to determine projected path forward and product disposition.Thorough and Timely Investigations, Root Cause(s) Identified and Corrective Actions Implemented Lead, investigate, write and provide support for all Exception Investigations, Triage Investigations, Out of Specification Investigations, SCARs and Customer Complaints. Perform risk assessments to support disposition of investigations. Lead and/or participate on equipment/process RCA investigation teams. Perform in-depth trending of Quality Systems to identify gaps and drive corrective actions. Own and drive implementation of Simple and Standard CAPAs. Create, revise, format, review and functionally approve SOPs, forms, batch records, training documents, etc., for technical and non-technical users.Project Management, Tasks Effectively Managed Prioritize and process work according to demand changes, production schedules and backorder. Assess workload capacity, adjust, delegate and/or seeks support as applicable. Effectively arrange and allocate time for efficiency and to meet deadlines. Utilize investigational checks lists, track and follow up on critical and non-critical outstanding items. Plan tasks accordingly to meet or exceed projected deadlines. Coordinates and sets clear agenda and expectations with others.Effective and Concise Communications Writes clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect. Works and communicates effectively in a team environment. Maintains and communicates routine daily status updates on all open investigations. Displays interpersonal skills, confidence, patients and fosters team environment.General Functions Performed: Prepare and present presentations for MRB and CAPA. Perform Change Controls. Lead and/or support projects as assigned by the Compliance Manager or Focus Factory. Provides training and support to equivalent or other level positions as needed. Performs other duties as assigned by supervision or as required by the position, including and not limited to duties of other level positions.Position Summary: Proficient in investigational writing. Knowledge of the listed essential functions and is able to perform/apply at a proficient to advanced level. Requires limited guidance, has sound decision quality and can individually make complex decisions while taking into consideration requirements and production demands. Leads and manages complex major events, projects and cross functional teams. Performs in-depth trending, identifying deficiencies/gaps and recommends/finalizes appropriate corrective actions with area owners. Acts as mentor for investigations, RCA, writing, etc. Conducts functional review and approval of investigations, change controls, forms/SOPs, batch records, etc.Minimum RequirementsEducation: High School Diploma or equivalent required. Bachelor or Associates Degree preferred with equivalent combination of education, directly related experience and competencies may be considered.Experience: 5+ years of related experience to perform the essential functions of the position within quality and quantity standards Excellent writing, editing, proofing and communication skills Attention to detail, accuracy, critical thinking and problem solving. Strong oral communication skills; experience in presenting technical information in a live setting. Project and time management. Organization. Ability to adapt rapidly to change, adjust responsibilities, time, and objectives accordingly with minimal oversight. Ability to analyze and synthesize complex content. Experience in creating documentation for audiences with different levels of technical skills. Knowledge of cGMPs Knowledge and understanding manufacturing and packaging instructions, processes, SOP's, etc. Knowledge, understanding and application of continuous improvement methods Knowledge, understanding and application of RCA tools and methods Basic computer skills including Word, Excel and database software. Interpersonal skills. Ability to effectively and professionally communicate at all organizational levels in a variety of settings and formats. Ability to identify and resolve people and task related issues involving non-standard situations.Organizational Relationship/Scope:Written Communications: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.Problem Solving: Rigorously and systematically connects information, processes and events by organizing divergent information and searching for common themes, patterns, and causal connections. Undertakes a complex task by breaking it down into manageable parts in a systematic, detailed way. Thinks of several possible explanations or alternatives for a situation and anticipates potential obstacles and develops contingency plans to overcome them. Uses intelligence, common sense, hard work and tenacity to solve particularly difficult or complicated challenges.Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sortsthrough ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.Keeping on Point: Can quickly separate the mission-critical from the nice to do and the trivial; quickly senses what's the next most useful thing to work on; focuses on the critical few tasks that really add value and puts aside or delays the rest.Influencing Others: Moves people toward willing involvement in a particular course of action using techniques that appeal to logic, values or emotion; presents arguments that address others' most important concerns and issues and looks for win-win solutions; involves others in a process or decision to ensure their support; identifies and proposes solutions that benefit all parties involved in a situation; accurately anticipates the implications of events or decisions for various stakeholders in the organization and plans accordingly.Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.Attention to Detail/Focus: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently. Double-checks the accuracy of information and work product to provide accurate and consistent work. Provides information on a timely basis and in a usable form to others who need to act on it. Compares observations of finished work to what is expected to find inconsistencies.Listening: Practices attentive and active listening; has the patience to hear people out; can accurately restate the opinions of others even when he/she disagrees.Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.

As a Corporate Writer, you will work in the office of the Founder/Partner and in close collaboration with RoundGlass Lead(er)s, subject matter experts, external advisory etc. on content initiatives, across multiple platforms and formats.You will write for the Founder/Partner's office and will set the content framework in terms of template (structure & flow) of concept notes, process/policy notes, company writeups. You will develop content that will accurately reflect company goals, objectives, and values.

This role will collaborate with the editorial, content, production, communications, marketing, design, IT, People & Culture teams across the RoundGlass ecosystem to help define both the brand story and the story as interpreted by the audience.

What you'll do:Ensure all content is on-brand, consistent in terms of style, quality and tone of voice and optimized for search and user experience including online, social media, email, point of purchase, mobile, video, print and in-person Utilize industry best practices and familiarity with the organization's mission to inspire ideas and content. Structure, plan and templatize individual projects.Leverage your own business understanding and content skills when partnering with leaders, research professionals, and editorial teams to develop and execute on the functional content calendar Steward each project through the content development process, bring in creative collaborators at the right stage to ensure that purposeful design principles are applied in a way that best suits the subject matter, its target audience, and its intended use/objective Work closely with editorial teams to ghost-write, rewrite, or substantively edit thought leadership content to ensure quality, readability, and audience engagement while maintaining the authors' voices Coordinate with content writers, designers, marketing, and other internal teams to ensure that project timelines are accurately set and met

Who we're looking for:Bachelor's degree (preferably in English Literature, Journalism, Mass Communications, or similar). MBA in Marketing a plus.10-15 years of experience as a respected leader in multichannel content creation (publishing, journalism, etc.).Exceptional writing fluency and knowledge of US English grammar, conversational phrasing and AP style, and the ability to explain edits to authors Excellent writing and oral communication skills; proven ability to translate complex concepts into easily digestible terms Excellent attention to detail, laser focus on quality, and ability to consider the big picture Outside-in orientation, considering all content projects from the perspective of the target audience and their needs/interests Versatile writing and editing skills, from writing engaging short-form web copy to developmentally editing long-form research reports on complex topics Experience with creating multimedia content Excellent stakeholder management and interpersonal skills, including the confidence to interact with and influence personnel at all levels, as well as listening skills, responsiveness, flexibility, initiative, decision-making, conflict resolution, and tact Project management skills to manage editorial schedules and deadlines within ongoing campaigns. Ability to work in a 24-hour project cycle-utilizing teams in other time zones Proficiency in Microsoft Word, content management systems, and workflow and collaboration tools such as Workfront, Microsoft Teams, etc.; knowledge of Excel and PowerPoint
Why RoundGlass:

RoundGlass was built on the vision that wellbeing should be at the very center of our life journey. We are not only reimagining how the world experiences wellbeing, but how companies (like our own) support the wellbeing of their people.

We're a group of talented, socially-conscious, gritty, innovators using technology and human energy to create a vibrant wellness ecosystem. Together, we've built an amazing community and we are always looking for people who share our passion. To learn more, visit our Website, Facebook, Instagram and LinkedIn.

RoundGlass does not discriminate against race, color, religion, sex, sexual orientation, gender identity, gender expression, pregnancy (including childbirth, lactation and related medical conditions), national origin, age, physical and mental disability, marital status, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

We rely on legitimate interest as a legal basis for processing personal information under the GDPR for purposes of recruitment and applications for employment.

• Bachelor's degree and 2+ Years Prior experience required in Computer Science, Information Technology, Informatics, Engineering, Statistics or equivalent
• SQL knowledge and experience working with relational databases, query authoring (SQL) as well as working familiarity with a variety of databases
• Experience with data visualization tools - ex: Tableau, Qlik, Power BI
• Familiarity with Cloud Datawarehouse technologies (Snowflake/Redshift) and AWS Cloud Services
• Strong mathematical skills to help collect, measure, organize and analyze data
• Proficiency in statistics and statistical packages like Excel, SPSS, SAS to be used for data set analysis
• Knowledge of how to create and apply the most accurate algorithms to datasets in order to find solutions
• Strong analytical & problem-solving skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy
• Adept at queries, writing reports, and making presentations
• Team-working, Verbal and Written communication skills
• Proven working experience in data visualizations

Designing and maintaining data systems and databases; this includes fixing coding errors and other data-related problems.

This position earns competitive compensation plus a full benefits package, including 401(k) with match and three weeks of PTO! We also offer opportunities for growth , as well as a great team atmosphere that empowers you to seek better ways to deliver service and take ownership of outcomes in providing quality service and support.

Please review the full job description for more details about this exciting opportunity.

ABOUT MILLENNIUM PHYSICIAN GROUP

Formed in 2008, Millennium Physician Group has grown into one of the largest comprehensive primary care practices with more than 400 health care providers located throughout Florida. With corporate headquarters in Fort Myers, Florida, Millennium Physician Group consists of primary care offices, Imaging Centers, Lab Services, Physical Therapy, and Wellness Programs. We also have several administrative departments supporting our medical offices, such as Quality Assurance, ACO, Business Services, Coding ACO, IT, Human Resources, and more.

If you are interested in joining an organization that emphasizes teamwork and family, then Millennium Physician Group is the right choice.

Millennium's core values summarize how we treat others, patients, and fellow community members. Millennium CARES for every patient every time.

Millennium Physician Group is proud to be an Equal Opportunity Employer and a Drug-Free Workplace. Additionally, Millennium is proud to join the nearly 3,000 health system and physician groups who have gone completely Tobacco Free.

ARE YOU READY TO JOIN OUR TEAM? If you are the right candidate for this position, please click the link to apply today. We look forward to meeting you!

Job Posted by ApplicantPro