Medical writer jobs in Indianapolis, IN - 36 jobs

See Yourself at Telix The Medical Writer will contribute to the achievement of Telix's strategic goals by leading and driving the writing process. This role will be responsible for planning and preparing a variety of clinical and regulatory documents necessary for all phases of clinical drug development. This role will provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data. Such documents include all types of regulatory documents, including eCTD summary documents (for INDs/NDAs/BLAs), clinical study reports, clinical study protocol synopses and protocols, Investigator Brochures, patient safety narratives, and briefing books, among others. Key Accountabilities: Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments. Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly. Work with colleagues, physicians, clinical scientists, and statisticians in a professional and organized manner to complete projects in a timely manner. Collaborate with project teams to respond to heath authority questions and requests. Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed. Maintain knowledge to enable ongoing execution of function as medical writing expert. Maintain working knowledge of the Telix clinical development pipeline. Education and Experience: Bachelor of Science a science or related field required; Advance degree preferred 5+ years of experience in regulatory medical writing required Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding medical terminology and statistical methodology is a must. Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy. The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word are required. Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as to review and edit on all levels, from copy editing to message strengthening to major rewriting. Experience and proficiency with document templates, document toolbars and proper version control. Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail. Key Capabilities: Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management** + Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. + Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. + Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. + Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. + Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. + Keep client and team informed of project status. + Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. + Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. + Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. + Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. + Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed. **Client** **Liaison/Service** + Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management. + Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. + Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management. + Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management. + If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects. **Training/Compliance** + Keep abreast of new advances in medical writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management. + Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate. + Develop and present external training courses. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform + Analyze efficiency of work and discuss improvement ideas with Medical Writing + Services management and colleagues, e.g., evaluation of software to increase productivity and document quality. **Skills:** + Excellent interpersonal, negotiation, verbal, and written communication skills. + A flexible attitude with respect to work assignments and new learning. + Motivation to work consistently in a fast-paced, rapidly changing environment. + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects. + Knowledge of resource management and productivity metric management. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Ability to travel. + Fluent in written and spoken English. **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. **Job Title: Endpoint Security Senior Technical Writer** **Job Description:** We are looking for a dedicated and skilled Senior Technical Writer to join our cybersecurity team. The ideal candidate will be responsible for creating, maintaining, and enhancing documentation that supports the planning, implementation, and operational readiness of multiple endpoint security initiatives. This role requires exceptional writing skills, a strong understanding of cybersecurity concepts, and the ability to collaborate closely with technical subject matter experts to produce clear, accurate, and standardized documentation. **Key Responsibilities:** 1. **Documentation Development:** 1. Develop, revise, and maintain high-quality documentation for cybersecurity technologies, processes, and workflows. 2. Create standard operating procedures (SOPs), implementation guides, engineering runbooks, and architectural overviews. 3. Produce documentation for system requirements, architecture designs, and operational readiness for new and existing solutions. 2. **Content Accuracy & Compliance:** 1. Ensure all documentation reflects current tools, configurations, and organizational standards. 2. Support documentation needs for compliance audits, risk assessments, and onboarding materials. 3. Align outputs with established documentation templates and governance frameworks. 3. **Collaboration & Knowledge Transfer:** 1. Work closely with cybersecurity SMEs, engineering teams, and operations to gather technical details and translate them into clear, user-friendly content. 2. Facilitate knowledge continuity by creating materials that enable smooth handoffs between teams. 4. **Continuous Improvement:** 1. Identify gaps in existing documentation and propose enhancements. 2. Stay informed on cybersecurity trends and incorporate best practices into documentation processes. **Qualifications:** + Strong technical writing skills with demonstrated ability to create clear, concise, and user-focused documentation. + Experience in cybersecurity or IT infrastructure environments, with familiarity in topics such as endpoint protection, SIEM, identity management, and cloud security. + Proficiency in documenting system requirements, architecture diagrams, SOPs, and implementation guides for technical audiences. + Excellent interviewing and collaboration skills to work with subject matter experts, engineers, and project stakeholders. + Familiarity with documentation tools and platforms, such as Confluence, SharePoint, Google Workspace, or equivalent. + Ability to interpret and standardize technical content, applying consistent tone, structure, and formatting across documents. + Understanding of documentation standards and style guides + Version control and change tracking awareness, including using tools like Git, document repositories, or structured file naming/versioning systems. + Experience in the utility sector, with an understanding of industry-specific terminology, operations, or regulatory environments. + Experience developing documentation specific to cybersecurity technologies used to protect systems within the utility vertical. + Experience in creating secure configuration and hardening guides for technologies used in utility environments (e.g., Windows, Linux, firewalls, etc.) + Familiarity with cybersecurity frameworks and standards, including NIST 800-53, NIST Cybersecurity Framework (CSF), ISA/IEC 62443, or ISO/IEC 27001. + Experience documenting critical infrastructure protection strategies, including risk assessments and vulnerability management programs. + Understanding of cybersecurity standards and ability to translate compliance and regulatory language into practical documentation. **What we offer you** At EY, we'll develop you with future-focused skills and equip you with world-class experiences. We'll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn more . + We offer a comprehensive compensation and benefits package where you'll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $77,500 to $140,900. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $92,900 to $160,500. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. + Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year. + Under our flexible vacation policy, you'll decide how much vacation time you need based on your own personal circumstances. You'll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being. **Are you ready to shape your future with confidence? Apply today.** EY accepts applications for this position on an on-going basis. For those living in California, please click here for additional information. EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities. **EY | Building a better working world** EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law. EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY's Talent Shared Services Team (TSS) or email the TSS at ************************** .

State Affairs is the nation's leading news and policy intelligence platform focused on state governments. We combine nonpartisan coverage of Statehouses across the country alongside state government data and AI-native tools into a singular platform. We inform and empower decision makers, policy professionals and citizens through our award-winning journalism and data - delivering profound insights to help our customers decode and act on state politics and policy. We're building a category-defining business that will reshape America as we strengthen visibility into what's happening and why at the state level. We are hiring a Managing Editor, Indiana to join our team located in Indianapolis, Indiana. As the Managing Editor, Indiana, you will: Ensure the delivery of compelling, relevant and accurate news stories to our readership Produce well-thought out profiles of leading actors in state politics as well as an occasional enterprise story on the inner workings of state government, state government agencies, policy makers and other movers and shakers. This Managing Editor is able to turn around a well-written and reported story on a tight deadline, if needed. Arrange interviews with government officials and others who can provide information about stories Review copy and correct errors in content, grammar and punctuation, following prescribed editorial style and formatting guidelines Determine a story's emphasis, length and format, and organize material accordingly Research and analyze background information related to news stories to be able to provide complete and accurate information Gather information about events through research, interviews, experience or attendance at political, social or other functions Pitch stories that are relevant to the local community Assist in developing and implementing editorial strategies to enhance audience engagement, increase readership and drive digital growth Elevate reporters' stories by seizing opportunities for in-depth enterprise stories, including those with statewide, and at times national, reach. Edit stories, graphics, pull quotes, info boxes, etc., for content, errors and libel, taking into consideration AP style and the in-house style guide. Essential Qualifications for this position include: 7+ years of professional work experience as a reporter or editor Bachelor's degree in journalism, or related field Prior professional work experience leading a team Knowledge of digital literacy and multimedia platforms and methods Knowledge of data-based reporting Ability to meet deadline Ability to adhere to the journalism code of ethics Ability to be persistent in conducting research Ability to edit stories, graphics, pull quotes, info boxes, etc. for content, errors and libel, taking into consideration AP style and the in-house style guide Ability to analyze and interpret metrics and use them to inform coverage decisions in real-time and the long-term Ability to communicate quickly and effectively with reporters to break news online and follow up when appropriate with more in-depth enterprise pieces. Excellent verbal and written communication skills Preferred Qualifications for this position include: Prior professional work experience in government reporting Prior professional work experience in a start-up organization This is an in-office work opportunity that operates most days out of the Indiana Statehouse in Indianapolis, Indiana. State Affairs offers a competitive salary and comprehensive benefits package to employees. The annual salary range for this role as it is posted is $85,000 to $97,000 for candidates working from Indianapolis, Indiana. The final job level and annual salary will be determined based on the education, qualification, knowledge, skills, ability, and experience of the final candidate(s), and calibrated against relevant market data and internal team equity. Benefits listed in this posting may vary depending on the nature of your employment with State Affairs. Candidates must be authorized to work in the United States without the need for current or future company sponsorship. State Affairs is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. State Affairs does not discriminate against applicants on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national origin, veteran status, disability, or any other protected characteristic in accordance with federal, state, and local law. State Affairs is committed to providing reasonable accommodations for qualified individuals with disabilities as they go through our job application and interview process. If you need assistance or an accommodation due to a disability, you may contact us at ********************* By submitting your application, you affirm the content contained therein is true and accurate in all respects. Please note that prior to employment, State Affairs will obtain background checks for employment purposes that may include, where permitted by law, the following: identify verification, prior employment verification, personal and professional references, educational verification, and criminal history. For certain roles, further background checks covering additional information and activities may be initiated. "By clicking "Submit Application" you are consenting to the use and retention of the information you have provided as set forth in the State Affairs Privacy Policy.

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at ************************* Its a simple route driver job and company will be providing the car. Job Description Job Details: Produce system documentation from the content provided by subject-matter experts (SMEs). Assist SMEs in creating quality documentation by providing guidance on format. Supports and/or contributes to the design, development, and delivery of end user training and/or procedures. Revise documents to support the resolution of incidents (Trouble Tickets) within committed service levels. Revise documents in support of the execution of change requests in compliance with local change control procedures. Operate with a quality mindset (capable, in control, compliant, and continuously improving). Primary Position Responsibilities (major or daily tasks): Documenting business and IT processes and systems. This resource must have the ability to quickly comprehend complex business processes and IT terminology in order to participate in technical discussions and walk away with a clear understanding of what was discussed and be able to document that understanding. Requirements / have to haves not listed elsewhere: This resource must have the ability to quickly comprehend complex business processes and IT terminology in order to participate in technical discussions and walk away with a clear understanding of what was discussed and be able to document that understanding. The individual must have strong communication and writing skills. Qualifications Requirements / have to haves not listed elsewhere: This resource must have the ability to quickly comprehend complex business processes and IT terminology in order to participate in technical discussions and walk away with a clear understanding of what was discussed and be able to document that understanding. The individual must have strong communication and writing skills. Additional Information All your information will be kept confidential according to EEO guidelines.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways. Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health. This role: The Sr. Technical Writer is responsible for performing site Non-Conformance Report (NCR), Significant SNCRs investigations, authoring CAPAs, standard operating procedures (SOPs), Clinical Batch Records, and miscellaneous technical transfer documentation as needed. This role will also play a critical role supporting training for operators. The candidate will execute these investigative tasks utilizing tools, identifying the root cause(s), documenting the results and processing the relevant records in the corporate Trackwise system, collaborating with impacted departments to determine appropriate corrective or preventive actions, related effectiveness criteria. Functioning in an interdepartmental capacity, this individual will author Batch records and technical documentation alongside Manufacturing and Technical Transfer personnel. Personnel filling this role will be supporting the Development and Pre-Commercial Services (DPCS) group within the Bloomington facility. The initial scope of role will be to perform duties as described with the opportunity to build a scalable organization of direct reports in the future. This candidate will sit onsite at the Bloomington facility and report to the Director of DPCS. The responsibilities: Develop the scope and devise an approach for assigned CAPAs, NCRs, Batch Records and miscellaneous technical development documentation. Demonstrate ability to quantify data to draw conclusions to drive continuous improvement through document revisions and leadership utilizing cross functional teams. Provide relevant experience for training manufacturing and technical personnel both directly and indirectly Establish a scalable framework and organization for execution of technical and quality documentation Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools Identify cross-functional team members and assemble the investigation/authoring teams Confirm corrections/containment identified based on the investigation results Determine the appropriate data sources to be evaluated for the investigation and obtain the required data\ Investigate the root cause(s) of the issue and document the investigation results Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle Collaborate with Action Owner/CAPA (Corrective Action and Preventive Action) Owner to develop the Action Plan/Effectiveness Plan\ Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs) Manage multiple investigations at any given time Responsible for speaking to clients and regulatory authorities to explain investigations Required qualifications: BS degree required, preferably in a science or technical area or equivalent experience 5+ years technical writing experience, preferably in pharmaceutical industry Demonstrate direct and indirect leadership ability Knowledge of applicable CAPA procedures, specifications, regulations and standards Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency Goal-setting, prioritize, organization, attention to detail, and time management skills Critical & creative thinking and problem-solving skills Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data Strong oral and written communication skills Ability to demonstrate strong leadership skills Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)\ Ability to utilize enterprise software systems (Trackwise) Physical / safety requirements: Duties will require overtime work, including nights and weekends on occasion Ability to gown in C/D gowning area In return, you'll be eligible for [1]: Day One Benefits Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance Spouse Life Insurance Child Life Insurance Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program Paid Holidays Paid Time Off Paid Parental Leave and more Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits Voluntary Insurance Benefits Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more Onsite Campus Amenities Workout Facility Cafeteria Credit Union [1] Current benefit offerings are in effect through 12/31/25 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Equal Employment Opportunity Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: **********************************

Collabera is ranked amongst the top 10 Information Technology (IT) staffing firms in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 12,000+ professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia), and Europe (Ireland, Netherlands, Poland, United Kingdom). We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers. Not only are we committed to meeting and exceeding our customer's needs, but also are committed to our employees' satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for five consecutive years since 2012. Collabera has over 50 offices across the globe with a presence in ten countries and provides staff augmentation, managed services and direct placement services to global 2000 corporations. For consultants and employees, Collabera offers an enriching experience that promotes career growth and lifelong learning. Visit ***************** to learn more about our latest job openings. Awards and Recognition --Staffing Industry Analysts: Best Staffing Firm to Work For (2016, 2015, 2014, 2013, 2012) --Staffing Industry Analysts: Largest U.S. Staffing Firms (2016, 2015, 2014, 2013) --Staffing Industry Analysts: Largest Minority Owned IT Staffing Firm in the US. Job Description A Fortune 500 manufacturing giant looking urgently for Technical Writer who write technical materials, such as equipment materials, appendices, or operating and maintenance instructions and will also be responsible for organizing, editing and maintaining technical records and files. NOTE: Recent graduates are also welcome to apply for this position ! Industry: Fortune 500 manufacturing giant Job Title: Technical Writer Location: Columbus, IN 47201 Key Responsibilities: · Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style and terminology. · Maintain records and files of work and revisions. Would be owner of the needed documentation for things assigned to them as needed. · Confer with client to establish technical specifications and to determine subject material to be developed for publication. This is where the selected hires would be working with the SMEs on the content that needs to be capture for documentation purposes. Qualifications Required Education, Experience & Skills: · A Bachelors' degree is a requirement for this request. Manager is seeking this level of education as this helps confirm the level of dedication someone has in order to complete said degree as well as the maturity level of that candidate. · Minimum of 2 years' relative working experience in technical writing is required. · Basic knowledge of media production, communication and dissemination techniques and methods · Basic knowledge of principles and methods for curriculum and training design. · Basic knowledge of computer software, such as Adobe, JavaScript, Oracle, etc. Additional Information If you want to know more and apply, please connect with: Niraj Singh **************************** ************ ************************************************

WHAT ARE WE ALL ABOUT AT ELEMENT THREE? Element Three is a full-service agency that bridges the gap for businesses in the dealer distribution model. We go beyond the obvious, bringing campaigns to life with big ideas, building brand strategies, telling stories, and creating meaningful marketing. Our purpose is to “foster growth in people and business so they can change the world.” The team at Element Three takes this mission seriously, and it is manifest in everything we do. We make good brands great. We are accountable for delivering results on our strategies. Every single time. What does this mean for you? You will join a team of tenacious, hard-working pros who excel in what they do and lift each other along the way. Role: Senior Copywriter As a Senior Copywriter at Element Three, you are a strategic communicator who understands how to craft compelling narratives that move people and deliver results. You're responsible for developing persuasive, brand-aligned messaging across a variety of channels, including digital campaigns, websites, video scripts, and brand identity work. You thrive in collaborative environments where creativity is balanced with strategic intent. You work seamlessly with designers, strategists, media experts, and client teams to create messaging that's rooted in business goals and resonates with target audiences. Your work drives engagement, builds brand loyalty, and moves prospects through the funnel. You can shift seamlessly from straightforward sales copy to attention-grabbing headlines that stand out from the crowd. This role requires critical thinking, adaptability, and a deep understanding of audience behavior. You can quickly absorb complex information and turn it into clear, compelling content that supports campaign objectives and brand strategies. To land this gig, you need: 5+ years of professional copywriting experience, preferably in an agency or B2B environment Proven ability to develop messaging frameworks, brand voice, and long-form and short-form copy across diverse formats Strong portfolio showcasing conceptual thinking, campaign development, and storytelling across mediums Experience working with art partners on comprehensive campaigns Understanding of SEO and GEO principles and how to incorporate them into effective content Ability to collaborate with art, strategy, and account teams to produce unified campaigns Strong editing and proofreading skills with a keen eye for detail and consistency Confidence in presenting work to clients and internal stakeholders, articulating the rationale behind your messaging choices This job might be right for you if: You are a strategic storyteller who transforms complex business challenges into compelling narratives. You understand that every word should drive toward a business goal. You are collaborative and excel at translating strategy into clear, actionable copy. You work seamlessly with designers, strategists, and account teams. You are curious about industries and quick to learn technical subjects. You can write with authority about products you've never used. You are data-driven and use performance metrics to refine messaging. You care about what works. You are adaptable and can adjust your tone and style to suit the audience and channel. You write equally well for C-suite executives and end consumers. As Senior Copywriter, a typical week might look something like this: Write and review email campaign copy for a powersports client's lead nurturing program, ensuring messaging aligns with their dealer sales process. Develop creative concepts for an RV client's new product launch. Collaborate with Paid Media Managers to optimize ad copy based on performance data, testing new messaging angles for better conversion rates. Work in tandem with an art director to visually and verbally rebrand an OEM. Review and provide feedback on website copy created by freelancers for an RV manufacturer's dealer portal. Partner with the Senior Marketing Strategist on competitive messaging analysis for a new business pitch, identifying unique positioning opportunities. Script a series of product demonstration videos for a heavy equipment client, ensuring technical accuracy while maintaining engaging storytelling. Engage freelance support on a project, providing clear direction and oversight on work product

Technical Writer needs 5+ years experience. Pharma, medica device industry Technical Writer requires: Technical writing Documentation SOPs Pharma medical device industry Develop and edits standard operating procedures, user tools, training materials, glossary content and global standards. Work with teams to document action plans to ensure SOP compliance, which includes writing and editing of documentation. Route documentation through review and approval processes in the document management system. Analyze existing documentation to ensure it is updated, reviewed, and maintained as appropriate with subject matter experts. Adhere to appropriate quality and verification-including SOPs and makes recommendations on system documentation. Organize existing and new documentation. Coach and train the other document controllers on technical writing concepts and instruction. S Suggest appropriate formatting for documentation. Serves as a point person for documentation advice and help. Reports status of documentation deliverables

Technical Writer Deviations & Change Control Our client, a pharmaceutical manufacturing company, is seeking a detail-oriented Technical Writer with expertise in deviations and change control documentation. This onsite role plays a critical part in ensuring regulatory compliance and supporting quality operations through precise, timely, and accurate technical documentation. Key Responsibilities Write, edit, and review high-quality technical documents including deviations, change controls, CAPAs, and other GMP-related records. Collaborate with cross-functional teams (QA, Manufacturing, Engineering, etc.) to gather accurate and complete information. Ensure all documentation complies with FDA, EU, and internal GMP guidelines. Translate complex technical information into clear, concise, and well-structured documents. Assist in audit readiness by maintaining organized, traceable documentation. Support investigations and root cause analyses by drafting clear summaries and conclusions. Qualifications Bachelors degree in Life Sciences, Engineering, or a related field. 5+ years of experience in technical writing within the pharmaceutical or biotech industry. Strong knowledge of GMP, deviation management, and change control processes. Excellent writing, editing, and communication skills. Proficient with Microsoft Office Suite; experience with TrackWise or other QMS platforms a plus. Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment. Applicants must be authorized to work in the United States. Sponsorship is not available for this position.

The Indianapolis Star, part of the USA TODAY NETWORK, is seeking college students and recent graduates with journalism experience for a rewarding and demanding fellowship. The news fellows will work 40 hours per week, with the potential to cover a range of politics, business, criminal justice, features and other news. Evening and weekend shifts will be required. We are looking for candidates who have curiosity and initiative. They generate their own story ideas as well as jumping on breaking news as assigned. They are comfortable sharing news via video as well as the written word. Why should I apply for this journalism program? You'll gain valuable hands-on experience, one-on-one coaching from our editors and a professional mentor as part of the prestigious Pulliam Journalism Fellowship. You'll get paid, too. Fellows earn $720/week ($18/hour) for the 10-week program. Am I qualified for this journalism program? Recent graduates and college juniors, seniors and graduate students enrolled in a journalism or related degree program as of Nov. 1, 2025, are eligible. Previous journalism experience via internships and/or your college newspaper is required. You need to be committed to a career in journalism. You must have reliable transportation and arrange for your own housing. We are an equal opportunity employer that values diversity among its journalism fellows. What's the deadline for this fellowship application? Applications must be submitted by Dec. 15, 2025, but they will be reviewed on a rolling basis, so candidates are encouraged to apply sooner rather than later. When should I be there? The 10-week fellowship can start anytime between mid-May - if you want to cover the mayhem that is the Indy 500 audience - and mid-June. How do I apply? Please attach your resume and cover letter along with your application. Your cover letter should address why you want to be a journalist and list your areas of coverage interest from among these possibilities: politics, features, business, criminal justice and breaking news. If you have questions, please contact Senior News Director Cindi Andrews at **************************.

The Technical Writer is crucial for translating complex technical processes and data into clear, accurate, and accessible documentation. The Technical Writer will work closely with the MSAT engineers and other cross-functional teams to create comprehensive documentation that supports tech transfer, process validation, GMP floor support, and continued process verification, ensuring that all materials meet regulatory and quality standards. Essential Job Functions: • Develop, author, and maintain a wide variety of technical documents, including but not limited to Process Flow Diagrams, Summary Reports, Process FMEAs, Master Batch Records, Bill of Materials, and Processing Forms, ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders. • Ensure all documentation is compliant with GMP standards and meets regulatory requirements, particularly for Process Performance Qualification and Continuous Process Verification. • Work closely with MSAT engineers, project teams, and clients to gather necessary technical information, facilitate effective communication, and ensure that all documentation reflects the latest process developments and changes. • Translate technical data and process monitoring results into comprehensible reports, identifying trends, proposing actions, and supporting troubleshooting efforts with clear, actionable documentation. • Establish and maintain documentation standards to ensure consistency across all technical documents. Continuously review and update documents to reflect process improvements, new technologies, and regulatory changes. • Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding GMP manufacturing processes and protocols. Special Job Requirements: • Associate's degree in an English major or in scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Engineering). A bachelor's degree is preferred. • Minimum of 0 - 3 years of experience in technical writing within a GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries. Additional Preferences: • Proficient in writing clear, concise, and accurate technical documentation. • Strong understanding of GMP manufacturing processes and regulatory requirements. • Excellent organizational skills with high attention to detail. • Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences. • Familiarity with documentation tools and electronic document management systems (EDMS). • Ability to manage multiple projects and deadlines simultaneously. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description Job Title: Technical Writer/Documentation Specialist Duration:- 1+ months Location: Indianapolis, IN, US Project Description: The Medicaid DW/DSS/BI will be a comprehensive, centralized-hybrid health and human services data warehouse with an open systems framework, containing leading integrated Commercial Off the Shelf (COTS) components, with wide-ranging business intelligence capabilities. This project will provide an environment that will be flexible enough to support any downstream analytical use of data. Under general supervision we are seeking to hire a Technical Writer/Documentation Specialist. The ideal candidate is someone with a technical writing background. The person holding this position will be responsible for writing various technical documents, documenting processes, and documenting and maintaining data lineage and the metadata repository. Basic Qualifications: - Must have 3 -5 yrs working experience as a Technical Writer/Documentation Metadata Coordinator/Specialist - 2yrs Data Analyst - 3yrs Technical Writing - 2yrs Data Warehouse Concepts knowledge Additional Information Thanks & Regards' Tanvi Kharbanda ************

Collabera is ranked amongst the top 10 Information Technology (IT) staffing firms in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 12,000+ professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia), and Europe (Ireland, Netherlands, Poland, United Kingdom). We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers. Not only are we committed to meeting and exceeding our customer's needs, but also are committed to our employees' satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for five consecutive years since 2012. Collabera has over 50 offices across the globe with a presence in ten countries and provides staff augmentation, managed services and direct placement services to global 2000 corporations. For consultants and employees, Collabera offers an enriching experience that promotes career growth and lifelong learning. Visit ***************** to learn more about our latest job openings. Awards and Recognition --Staffing Industry Analysts: Best Staffing Firm to Work For (2016, 2015, 2014, 2013, 2012) --Staffing Industry Analysts: Largest U.S. Staffing Firms (2016, 2015, 2014, 2013) --Staffing Industry Analysts: Largest Minority Owned IT Staffing Firm in the US. Job Description A Fortune 500 manufacturing giant looking urgently for Technical Writer who write technical materials, such as equipment materials, appendices, or operating and maintenance instructions and will also be responsible for organizing, editing and maintaining technical records and files. Industry: Fortune 500 manufacturing giant Job Title: Technical Writer Location: Columbus, IN 47201 Key Responsibilities: · Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style and terminology. · Maintain records and files of work and revisions. Would be owner of the needed documentation for things assigned to them as needed. · Confer with client to establish technical specifications and to determine subject material to be developed for publication. This is where the selected hires would be working with the SMEs on the content that needs to be capture for documentation purposes. Qualifications Required Education, Experience & Skills: · A Bachelors' degree is a requirement for this request. Manager is seeking this level of education as this helps confirm the level of dedication someone has in order to complete said degree as well as the maturity level of that candidate. · Minimum of 2 years' relative working experience in technical writing is required. · Basic knowledge of media production, communication and dissemination techniques and methods · Basic knowledge of principles and methods for curriculum and training design. · Basic knowledge of computer software, such as Adobe, JavaScript, Oracle, etc. Additional Information If you want to know more and apply, please connect with: Niraj Singh **************************** ************ ************************************************

Technical Writer needs 3+ years technical writing experience Technical Writer requires: Technical writing SOPs Analyze Training material Develop and Edits standard operating procedures, user tools, training materials, glossary content and global standards. Work with teams to document action plans to ensure SOP compliance, which includes writing and editing of documentation. Route documentation through review and approval processes in the document management system. Analyze existing documentation to ensure it is updated, reviewed, and maintained as appropriate with subject matter experts. Adhere to appropriate quality and verification-including SOPs and makes recommendations on system documentation. Organize existing and new documentation. If expertise in technical writing, then will need to coach and train the other document controllers on technical writing concepts and instruction. Suggest appropriate formatting for documentation. Serves as a point person for documentation advice and help

We are seeking an Enterprise Systems Technical Writer who is agile, collaborative, and passionate about technology and systems development. This role blends technical writing expertise with core business systems analysis skills. The Enterprise Systems Technical Writer will work closely with IT, Quality, Validation, and project teams to quickly learn new processes and systems, then translate that knowledge into clear, accurate documentation-including SOPs, validation documents, and training materials-to support the deployment and adoption of new enterprise systems. You'll be instrumental in documenting new enterprise systems, ensuring GMP compliance, and enabling our teams to adopt technology that drives operational excellence. Essential Job Functions: Rapidly learn new enterprise systems and business processes through collaboration with subject matter experts and hands-on exploration. Develop, update, and maintain high-quality documentation such as Standard Operating Procedures (SOPs), validation protocols, user guides, and training materials for IT and business systems. Partner with program managers, subject matter experts, quality assurance, and validation to capture requirements, workflows, and system capabilities. Translate complex technical and business concepts into clear, user-friendly documentation for diverse audiences across the organization. Support system deployment and adoption by creating materials that facilitate training and onboarding for personnel. Ensure documentation aligns with regulatory requirements, industry standards (e.g., GxP, Data Integrity, Good Documentation Practices), and internal quality guidelines. Participate in system validation activities, assisting with the creation and review of validation documentation. Collaborate with stakeholders to identify documentation needs and continuously improve content based on feedback and evolving business processes. Maintain version control and accessibility of documentation assets to ensure reliability and security. Special Job Requirements: 3+ years of experience in technical writing, preferably in IT or regulated environments. 2+ years of experience in business systems analysis or related roles. Demonstrated ability to quickly learn new systems and processes. Experience developing SOPs, validation documents, and training materials. Experience with CSV documentation in pharmaceutical, biotech, or medical device industries. Familiarity with software development life cycle, system validation, and compliance standards. Excellent written and verbal communication skills. Proficiency with documentation tools such as Microsoft Office Suite, Visio, or similar workflow mapping tools. Experience creating visual documentation (process flows, system diagrams, user interface mockups Bachelor's degree in Computer Science, Life Sciences, Engineering, Technical Communication, or equivalent experience. Additional Preferences: Experience with enterprise systems is a plus (ERP, LIMS, QMS). Advanced degree or certification in Informatics, Technical Writing, or Business Analysis is desirable. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at ************************* Its a simple route driver job and company will be providing the car. Job Description Job Details: Produce system documentation from the content provided by subject-matter experts (SMEs). Assist SMEs in creating quality documentation by providing guidance on format. Supports and/or contributes to the design, development, and delivery of end user training and/or procedures. Revise documents to support the resolution of incidents (Trouble Tickets) within committed service levels. Revise documents in support of the execution of change requests in compliance with local change control procedures. Operate with a quality mindset (capable, in control, compliant, and continuously improving). Primary Position Responsibilities (major or daily tasks): Documenting business and IT processes and systems. This resource must have the ability to quickly comprehend complex business processes and IT terminology in order to participate in technical discussions and walk away with a clear understanding of what was discussed and be able to document that understanding. Requirements / have to haves not listed elsewhere: This resource must have the ability to quickly comprehend complex business processes and IT terminology in order to participate in technical discussions and walk away with a clear understanding of what was discussed and be able to document that understanding. The individual must have strong communication and writing skills. Qualifications Requirements / have to haves not listed elsewhere: This resource must have the ability to quickly comprehend complex business processes and IT terminology in order to participate in technical discussions and walk away with a clear understanding of what was discussed and be able to document that understanding. The individual must have strong communication and writing skills. Additional Information All your information will be kept confidential according to EEO guidelines.