Medical writer jobs in Louisville, KY

Job Title: Technical Writer / Analyst Contract Duration: 3-months (intention of a long-term engagement) We are seeking a mid-level Technical Writer / Analyst to support a major Warehouse Execution System (WES) implementation and other site-wide IT initiatives at a leading pharmaceutical distribution site. This role is ideal for someone who is detail-oriented, proactive, and eager to roll up their sleeves to drive documentation and validation efforts across multiple projects and stakeholders. Key Responsibilities: Draft and manage documentation (e.g., requirement specs, test plans, evaluation reports) across multiple concurrent IT and (EWM systems) projects. Collaborate with Subject Matter Experts (SMEs), Project Managers, and Quality teams to gather technical input and translate it into clear, compliant documentation. Support test planning and execution in the first month, followed by ongoing design and documentation of validation deliverables. Assist in wrangling SMEs and coordinating across global and local teams to ensure timely delivery of documentation. Contribute to evaluation plans and reporting for system-wide initiatives, including miscellaneous reports and site-wide planning deliverables. Ensure adherence to System Development Life Cycle (SDLC) and regulatory requirements (GXP, data integrity, privacy). Participate in technical discussions to stay aligned with evolving project needs. Interface with corporate and global teams, initially supporting local execution and potentially broader compliance initiatives. Ideal Candidate Profile: 3-5 years of experience in technical writing, or IT documentation-preferably in a regulated environment. Strong understanding of GXP, SDLC, and data integrity principles. Comfortable working in fast-paced, agile environments where documentation is often being created from scratch. Excellent written and verbal communication skills; able to synthesize complex technical input into clear, structured documents. Demonstrated ability to take initiative, chase down information, and work independently while coordinating with multiple stakeholders. Background in Warehouse Management or IT (Computer Science, Information Systems, or related field) is preferred. Experience with WES platforms or warehouse systems is a plus. Additional Notes: This role is onsite and will require close collaboration with both contractors and internal teams. The successful candidate will be part of a growing team and may move with the group as projects evolve. There is a strong emphasis on extension-this is a great opportunity for someone looking to grow into a long-term role. Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

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

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service. **How you'll make an impact:** + Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department + Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties + Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle + Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams + Review and interpret study data analyses + Contribute to the generation of product life cycle plans (e.g., post-market surveillance). **What you'll need (Required):** + Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria + Demonstrated track record in people management or equivalent work experience based on Edwards criteria **What else we look for (Preferred):** + Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria + Medical writing or regulatory certification or equivalent work experience based on Edwards criteria + Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria + Experience working in a regulated industry or equivalent work experience based on Edwards criteria + Certification in related fields + Strong leadership in project and team management, including coaching and performance oversight. + Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines. + Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations. + Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). + Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate. + Familiarity with coronary interventional and structural heart environments. + Proven ability to develop metrics demonstrating medical writing value to the business. + Ability to thrive in a fast-paced, dynamic environment with strict attention to detail. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities •Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client. •Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. •Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. •Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed. •Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. •Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs. •Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. •Performs online clinical literature searches and complies with copyright requirements. •Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities. •Mentors and leads less experienced medical writers on complex projects, as necessary. •Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. •Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. •Completes required administrative tasks within the specified timeframes. •Performs other work-related duties as assigned. •Minimal travel may be required (less than 25%). At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $0.00 - $0.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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.

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. Our MSLs are a field-based extension of the Medical team, who represent and reflect argenx's values as a science-driven, patient-centric organization. This position will engage with key stakeholders at academic and community health centers, serve as a strategic partner to fellow cross functional team members and are experts on argenx's scientific data, products and trials. This position will report directly to the MSL Director, Immunology Rheumatology Medical Science Liaisons in respective regions. Roles and Responsibilities: Developing medical and scientific expertise in rheumatology pipeline indications including Sjogren's Disease, Myositis, and other pipeline indications Develop and maintain the highest scientific and medical expertise of relevant diseases, compounds, development indications and respective treatment plans Be acknowledged internally and externally as an expert in aligned areas Partner with Medical Affairs, HEOR, Patient Advocacy and other relevant stakeholders to create a thorough internal understanding of pipeline indication opportunities Identify potential high-impact medical research projects and publication opportunities (e.g., white papers to inform treatment guidelines), in line with argenx identified areas of interest Attend appropriate local, national, and international meetings and congresses to gather intelligence, develop productive collaborations, ensuring insights are shared within argenx KOL engagement Develop and maintain relationships with healthcare Key Opinion Leaders (KOLs) within Rheumatology and other relevant specialties to collaborate on research projects, advisory boards and peer-to-peer educational initiatives Collaborate with KOLs on evidence generation appropriately including sponsored, translational, and outcomes research Identify, recommend and support principal investigators for on-going and planned clinical trials Promote clinical trial engagement through scientific exchange and presentations Ensure timely and informative scientific/medical exchanges and education for healthcare community on topics like disease awareness, diagnostics, treatment and adherence that accurately reflect scientific data and research objectives, compliantly and in line with medical strategy Responsible for tailoring engagement strategies by adeptly recognizing and accommodating the stakeholder archetypes (e.g., academic vs community) and their informational needs Respond to questions from the healthcare community with integrity, compliance, and adherence to all legal, regulatory, and argenx guidelines, policies & procedure Cross-functional collaboration Ensure close working relationship with cross-functional field and other appropriate internal partners compliantly, to ensure launch readiness Support cross-functional teams to ensure operations are patient-focused, including rapidly responding to internal and external requests, to provide medical affairs support to all stakeholders Skills and Competencies: Cross-therapeutic area, portfolio-oriented mindset and strong aptitude for effectively working with cross-functional teams Scientific and customer-centric mindset with successful track record of delivering results that meet or exceed targeted objectives Demonstrated ability to build relationships and collaborate productively with external stakeholders (e.g., medical experts, healthcare professionals) Effective collaborator on cross-functional teams with a variety technical expertise and backgrounds Able to quickly understand complex disease areas, treatments and clinical development plans Thorough understanding of clinical trial phases and execution Able to problem solve proactively and translate territory/organizational needs into action Can operate with significant autonomy to assess priorities and customize decisions in real time Flexible to travel within region, USA, and global based on business needs Education, Experience and Qualifications: Scientific, healthcare or medical degree (PharmD, PhD, MD, DO) 3+ years of field-based MSL experience in biopharmaceutical industry Preferred candidates are located in the targeted cities or are within a reasonable range of a major airport within the territory Strong clinical and scientific knowledge in rheumatology is preferred and immunology and/or other rare diseases is an advantage Preference to candidates with experience supporting clinical trial sites as an MSL to support clinical trial key milestones Strong knowledge of the US healthcare landscape, including hospital systems and healthcare professionals Strong understanding of compliance, legal and regulatory landscape related to interactions with healthcare professionals Fluency in translating market research and data-driven insights into actionable strategic initiatives Proficient in Microsoft Office Suite and VEEVA #LI-Remote For applicants in the United States: The annual base salary hiring range for this position is $184,000.00 - $276,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com . If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at **************** . Only inquiries related to an accommodation request will receive a response.

Job Description RoseHarbor Publishing is looking to secure a talented Series Editor for multiple series of novel-length books (80,000-90,000 words) within the mafia romance genre. We are seeking a dependable editor to work with long-term in a team environment. While this will be on a book-by-book basis initially, starting with the continuation of an ongoing series, we will require many books to be edited on a regular basis (weekly and monthly) as you learn our style and progress to various levels of editing/rewriting difficulty. Scope of work: Utilizing our online platform, you will follow a series from beginning to end while completing a training process that will support you in learning our style. Series editors: Provide feedback and suggestions on each version of a book outline as it is created in the form of a developmental critique within the document. Critique writers' submissions as they are posted, providing coaching and feedback on a chapter-by-chapter basis. Spot discrepancies in plot, background story, point of view, worldbuilding, and timeline in a single book and between books in a series when critiquing both outlines and manuscripts. Ensure the book meets genre expectations regarding main character traits (i.e.: for mafia romance, the male main character should be dangerous and morally gray), romance arc, inclusion of popular mafia romance tropes, and plot. Coach writers by pointing out style weaknesses, using our guidelines to strengthen their writing skills. Request revisions from writers and approve those revisions. Complete two rounds of substantive editing with editing director input in between. This may involve complete or partial reorganization and rewriting to ensure quality of each novel is maintained. Every book will be passed through additional layers of editing. After each pass, the series editor will fix any issues the downline editors find. Research to fact-check specific details regarding settings, titles within various organized crime syndicates, and/or any other elements that aren't common knowledge to ensure accuracy. Check any non-English terms in the book for accuracy. Display a high level of discretion, diplomacy, and tact in dealing with writers. Answer outline writers' and book writers' questions as they write each book or outline on our online platform. Self-edit and proofread own work before submitting. Track character details with Master Character List. Are proficient with Microsoft Word's track changes and commenting system. Adhere to Chicago Manual of Style. Adhere to RoseHarbor's Publishing Style, which will be provided. Adhere to standard U.S. English. Note: Editors will be paid separately for each process they are responsible for: manuscript critiquing/questions, outline critiquing/editing, editing/rewriting novels, and final novel polishing (more details with interview). Requirements: Strong grasp of the romance genre in general and familiarity with mafia romance in particular. Knowledge of popular genre tropes. Willingness to read and discuss popular mafia books assigned to them. Strong romance and character development, suspenseful writing, creation of emotionally intense scenes as well as steamy sex scenes are a must-the story is as important as a book with correct grammar and clean copy. We create compelling romances with action and twists and will depend on you to maintain our high level of quality in our stories with an exceptional eye for detail and accuracy. Able/willing to learn our author's voice and emulate that voice. Write/edit in both first person and third person point of views, past and present tense, while alternating character POVs per each scene. Good research and fact-checking skills to ensure basic details are accurate (such as the Russian mob being known as the bratva) and be able to write/edit characters who are involved in organized crime syndicates. You will receive (and help maintain) a Master Character List in which you will be required to fact-check character details while editing. High levels of discretion, diplomacy, and tact in dealing with writers and editors. Deadline driven and able to respond to communication within 24 hours-very important. Must learn our style: Chicago Manual of Style, Merriam-Webster, change passive writing to active writing, be able to apply a list of our guidelines to the edit and work with writers to incorporate our style into writing. Ability to spot discrepancies in plot and background story in a single book and between books in a series, using the Master Character List for reference. Able to self-edit and proofread own work before submitting. Work in an online shared team environment. Be able to work in a fast-paced environment where editing and revision deadlines must be met. Be able to fill in for another editor and finish a series if necessary, emulating the characters of the series. Use updated version of Microsoft Word track changes function. Our readership is primarily comprised of women. You will have some creative license, and we expect your work to be self-edited and proofread. Our editing director and team will go over your work, and if needed, send it back to you for revisions and/or suggestions or to answer questions. You will be working with editors who are experienced in the genre on an online shared environment, and you must be open to constructive criticism from another set of eyes. The team will provide help and suggestions where needed, as well as brainstorming on the plot if necessary. The goal is to work together to create the perfect mafia romance series. You must have time to devote to editing full-length novels, outlines, critiquing for revisions, etc., each month. Excellent communication skills are essential, as communicating with us for deadlines and with the writers about plots and revisions is a must. We work as a team and care about our writers and editors. This is a good opportunity for someone who wants job security. Ownership and Legal: Understand that this is a work-for-hire independent contractor position-editors hold no rights to the work and must adhere to all legal and ownership agreements set by RoseHarbor Publishing. Willing to sign a Non-Disclosure Agreement (NDA) for each book and outline. All submitted work must be 100% original. AI-generated, AI-assisted, pre-written templates, or PLR (Private Label Rights) content will not be accepted. Submissions that appear to rely primarily on AI, templates, or PLR material will be disqualified. **Please note that we pay a per word or flat fee, we needed to include an hourly rate to advertise the position, but we do not pay hourly**. Powered by ExactHire:182716

Xcelerate Marketing agency, we focus on making unique creator brands, and bringing these brands to life on social media platforms. Key requirements and skills: Must be a college student or have experience in social media marketing Edit high-quality Reels for Instagram and other platforms using CapCut Add music, transitions, effects, and text to produce viral-worthy content Collaborate closely with our creative and social media team Stay on top of trends and pitch innovative video ideas Who You Are: Skilled in CapCut and short-form video editing Creative storyteller with an eye for detail Able to deliver fast turnarounds under tight deadlines Have a strong portfolio of Reels or similar short-form content Understand current social media trends and best practices What We Offer: Remote and flexible work options Chance to work on high-visibility, trending projects A collaborative, creative team environment Ready to Join Us? If you're excited to create scroll-stopping Reels, we'd love to see your work!

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: The Senior Medical Science Liaison (Senior MSL) serves as a field-based advanced technical, scientific, and medical expert, answers product-related questions from HCPs, and provides clinical/scientific presentations and medical education programs. The Senior MSL is responsible for developing, coordinating, and assuring implementation of Ardelyx's corporate, scientific, and clinical strategies with Key Opinion Leaders (KOLs) within academic, clinical, and healthcare organizations. These scientific exchanges will support and/or expand current therapeutic concepts, as well as ensure the safe and effective utilization of Ardelyx's assets. The Senior MSL builds upon the foundational responsibilities of the MSL by providing advanced scientific engagement, deeper strategic input, and informal leadership across the Field Medical Affairs function. The Senior MSL is recognized as a subject matter expert, mentor to peers, and key contributor to national field medical initiatives as required, playing an important role in aligning field insights with broader medical strategy. Responsibilities: * Serve as the primary field-based medical liaison in providing medical information and scientific exchange to external/internal stakeholders * Identify, establish, and manage collaborative relationships with local, national, and regional medical/scientific leaders/investigators to identify and address scientific needs * Present healthcare professionals and decision makers with accurate, unbiased, balanced, and timely answers to unsolicited requests for information in the therapeutic field responsible * Establish scientific and clinical relationships with thought leaders and academic/community centers to expand research and educational opportunities * Engage in non-product discussions regarding scientific topics (e.g., disease state, diagnosis, epidemiology, unmet medical need, population health, etc.) * Prioritize and work effectively in a self-directed manner in a constantly changing environment, including ability to obtain, integrate and communicate HCP feedback * Participate in advisory boards and other company meetings * Attend key medical and scientific congresses and conferences (local, regional and national) as needed * Lead department-wide projects and participate in cross-functional activities that serve strategic initiatives * Provide strategic insights by maintaining expertise in the therapeutic area and related fields to effectively communicate scientific insights and support strategic objectives * Monitor the competitive environment for advances and trends in the therapeutic area, including new treatment management and therapies, competitive products and provide feedback to internal stakeholders on specific initiatives of competitors * Serves as peer leader to mentor and coach new or junior MSLs, supporting onboarding, training, and field excellence Qualifications: * Doctorate degree (PharmD, PhD, MD, DNP, etc) in biological sciences with 5+ years of MSL Medical Affairs expertise within the therapeutic area or equivalent experience * Advanced Medical/Scientific masters degree (NP, PA) with combined extensive clinical expertise will be considered * Ability to apply technical expertise and solutions to diverse/individualized situations * Critical data analysis skills * Excellent communication & presentation skills * Networking skills and the confidence to interact with senior experts on a peer-to-peer level * Demonstrated ability to integrate and work in cross functional network/matrix * Prior experience in mentorship of medical science liaisons * Demonstrated project management ability * Knowledge of FDA and OIG requirements, as well as the PhRMA Code, including regulations governing compliant scientific exchange * Ability to travel locally, regionally, and nationally as requested/required; up to 70% travel * Valid driver's license The anticipated annualized base pay range for this full-time position is $185,000-$232,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

**Customer Engagement Model** Otsuka America Pharmaceutical, Inc. has launched a new customer engagement approach designed to better deliver on patient, caregiver, and HCP needs in an evolving healthcare environment. The new model is built around where patients get their care-locally, with the intent to better serve patients, caregivers, and healthcare providers, delivering a higher quality experience that ultimately is focused on improving patient care. The local "ecosystem approach" creates a unified focus among account management, medical, patient access and market access to engage local healthcare systems and identify opportunities to improve the patient experience. Through this matrix model, customers will now experience more coordinated and seamless care with digital-enabled support to bridge care gaps. In Otsuka's evolved customer engagement model, a Health Science Associates (HSA) will engage HCPs through a variety of in-person, virtual and digital tools, offering expanded expertise regarding products and the approved conditions they treat. Otsuka's Clinical & Scientific Liaison (CSL) will provide deep clinical expertise on-demand and will engage healthcare providers to offer personalized education on disease state, thought leadership and real-world evidence. A Patient Education Liaison (PEL) works to inform, educate, and enhance the experience of patients throughout their care continuum. The HSAs are led by Ecosystem Leads and grouped into regional areas. Ecosystem Leads are led by Regional Leads with significant autonomy to assess unique market priorities and customize decisions that reflect local customer needs. In the future, Otsuka will also be shifting to a team-based approach to drive customer engagement quality, accountability, and cohesion around patients and healthcare providers. Ultimately, it is all about putting customers at the center of everything they do. **Position Overview** **- Medical** **Science Liaison** **(Senior Manager)** As an integral member of the ecosystem team for Otsuka's new ecosystem-based customer engagement model, the Medical Science Liaison (MSL), Sr Mgr contributes to the development of the ecosystem strategic business plan and identifies key stakeholders that are vital to the ecosystem. The Medical Science Liaison (MSL) is a credible partner responsible for providing clinical, scientific and health economic information related to disease states and the appropriate utilization of approved Otsuka products within an ecosystem. This field-based position will engage with Key Influencers (KIs), Local Practice Leaders (LPLs), healthcare providers, and patients' groups within their ecosystem, to further patient outcomes aligned with the overarching objectives of Otsuka. In collaboration with their ecosystem partners, CSLs contribute to the customization of the region business strategy to meet local ecosystem needs and are responsible for the medical and educational requirements of their customers. In addition, CSLs may be responsible for covering multiple products within a therapeutic area, as well as engaging in broad clinical and scientific discussions that impact patient care, resulting in rich customer insights shared within the ecosystem. **There are 2 positions available** **Key Activities and Responsibilities** + As part of the ecosystem team contributes a clinical and scientific perspective to the local execution plan that addresses ecosystem, and customer challenges, issues, and opportunities, to bring about improved patient care and outcomes. This extends to include coordination around execution of field activities. + Build, cultivate, and leverage external relationships with key scientific and medical customers and organizations within their ecosystem to ensure strong understanding of evolving healthcare trends, disease state, Otsuka products, systems, and services across the ecosystem landscape, including KIs, LPLs, Key Decision Makers (KDMs) and Patient Advocacy. + Maintain a comprehensive understanding of the ecosystem to ensure alignment with Otsuka's patient-centric strategy and priorities, including provision and delivery of optimal patient care. + To be a credible source of evidence-based information that demonstrates the value of Otsuka and its products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers, and other key stakeholders to apply practical real-world solutions to improve patient outcomes. + Build and cultivate important internal working relationships across the matrix team to ensure an enterprise approach when working with customers. Be accountable to regional Field Medical Affairs leadership to shape and execute on local medical strategies within planned timelines. + Actively contribute to planning, content development, and dissemination of disease state information to customers in the field on a regular basis using the remote customer engagement platform. + Disseminate disease state and healthcare landscape information to customers in the field on a regular basis utilizing remote customer engagement platform. + Responsible for delivering the training and evaluation of promotional and disease state speakers. + Serve as part of Otsuka's internal speaker bureau in support of product educational needs across the ecosystem. + Collect and submit medical insights that drive decision making and prioritization of evidence generation efforts and healthcare solutions, including sharing at the local ecosystem level. + Assist with Otsuka's clinical trials program, including registrational, post-marketing and Investigator-Sponsored Trials (ISTs), health economic outcomes research, other specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance. + Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research or Public Health, (PharmD., M.D., PhD. or D.Ph.) is required. + Relevant therapeutic area knowledge is required. + Understanding of the interconnectivity of health systems, overall delivery of patient care and experience working with healthcare professionals and other decision makers. + Minimum of 3-5 years related work experience (clinical, health system or industry) + Outstanding business acumen; knows the industry, Otsuka's business model and value proposition, key competitors, and other marketplace factors/dynamics. Able to identify solutions with the overall goal of improved patient outcomes. + Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills: proven ability to achieve conflict resolution effectively and quickly with affected parties and work in a cross-functional environment. + Knows how to summarize and communicate complex information and business objectives in a concise and effective way during presentations and other interactions. + Understanding of industry legal, regulatory, and compliance landscape + Ability to work in an ambiguous environment undergoing transformation. + Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility. + Business travel, by air or car, up to 70% of time depending upon size of ecosystem. + Preferred living location is key city in ecosystem. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Medical Value Access Liaison - Southeast US Territory Coverage: Southeast Coverage to include KY, VA, TN, NC, SC, GA, AL, FL, PR What you will do Let's do this. Let's change the world. In this vital role you will develop programs, activities and relationships, both externally and internally to Amgen, in order to advance the value and clinical knowledge of our products to the payer community. This is a field-based position within the Medical Value & Population Health team, within the Regional Medical Value Access Liaisons (MVAL) group in Scientific Affairs, reporting to a Director. Geographic region for this position is within the U.S. business and majority regional accounts and select payer integrated IDNs as assigned. Responsibilities: * Provide Payer and Formulary Support through value and medical presentations that focus on therapeutic as well as economic outcomes and utilization aspects of products, and in clinical policy discussions such as evidence-based medicine, clinical guidelines and prior authorization in areas where Amgen has therapeutic expertise. * Identify, develop, and maintain collaborative relationships with current and future Payer, Policy, IDN, and Health Economic and Outcomes Research opinion leaders through identifying speaker opportunities and concepts and letters of intent for investigator supported economics, humanistic outcome, and non-registration clinical studies to support Amgen's product messages within scope. * Interact with key internal stakeholders to provide feedback on customer trends in interpreting and using value evidence, reimbursement and payer policy. * Provide complex value-based technical information inclusive of medical education, health outcomes and Pharmacoeconomics information and models and research protocol opportunities to appropriate audiences. * Represent Amgen Scientific Affairs to designated payer & select IDN accounts. * Represent Amgen to designated thought leaders in health economics and outcomes research for Amgen Global Health Economics (GHE) and Amgen Center for Observational Research (CfOR). * Foster scientific information exchange as it relates to reimbursement and coverage policy between the medical community and Amgen. * Collect and report competitive intelligence within Amgen's competitive intelligence guidelines. * Effectively manage internal relationships, budgets, and T and E within guidelines. * Conduct all assigned duties within Amgen compliance guidelines. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Medical Value Access Liaison with these qualifications. Basic Qualifications: Doctorate degree & 2 years of Medical Affairs experience OR Master's degree & 6 years of Medical Affairs experience OR Bachelor's degree & 8 years of Medical Affairs experience Preferred Qualifications: * Pharm.D., Ph.D., M.D. or D.O. * Five years Biotech industry experience working directly with US Payer Accounts * CV, Metabolic, Inflammation, Bone, Neuro Oncology therapeutic area expertise * Deep knowledge of managed markets, US Reimbursement Landscape, Pharmacoeconomics, Population Health, and other broad healthcare trends. * Experience in Patient Access in US and / or global markets * Project management experience within a biopharmaceutical company * Strong advocacy, communication and team cohesion skills * Critical thinking, analytical and project management skills * Ability to lead and manage projects from concept to completion * Strong interpersonal skills, negotiation skills, active listening, and relationship management skills * Interface effectively with all levels, including senior management * Ability to influence others while fostering a value-based environment of dedication and fairness * Ability to understand, plan, and navigate in a matrix and, at times, ambiguous environment * Strong verbal and written communication skills; ability to clearly and effectively present information * Demonstrates creativity and foresight in anticipating and solving complex project issues What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans * Flexible work models, including remote and hybrid work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 174,186.00 USD - 201,183.00 USD

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Education and Typical Years of Experience: Bachelor's degree in a related field (e.g., English, Communications, Technical Writing, Instructional Design) or equivalent work experience. Master's degree in Technical Communications or related field such as Instructional Design is a plus. Expert written communications skills are required. Minimum of 5+ years' experience developing user manuals, help systems, and CBT modules, including 3 -5 years' experience developing user documentation/CBT for large, functionally complex systems. · 5+ years' experience with tools such as FrameMaker, Microsoft Word, MadCap Flare, RoboHelp, Captivate, Brainshark, Camtasia Microsoft Visio, including experience managing templates and style sheets. · Experience using information development tools to single-source user manuals and help systems is a plus. · Experience working in globally dispersed work teams (onshore and offshore resources) is a plus. · Experience in developing training materials is desirable. · Experience with instructional design principles is desirable. · Previous participation in formal process improvement (ISO, PMP, CMMI, Six Sigma) is a plus. Additional Information $36hr 6 months

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance. Job Description Job Title: Technical Writer I Duration: 6 month (High possibility of extension) Position Summary: • Develops high-quality information/documentation for Cummins applications. Key responsibilities for this position will include the following: • Develop/maintain design documentation and information provided by subject matter experts in the engineering and service functions. • Integrate relevant information into well written text instructions, functional descriptions, and operation and service procedures with illustrating graphics. • Develop and manage a resource plan, project schedule and work plan for multiple and complex projects. • Maintain and communicate status for all active projects. • Assist in maintaining a departmental schedule and resource assignments as projects and organizational priorities shift. • Lead improvement activities that reduce translation cost and complexity and improve content quality. • Develop the framework to publish, update and maintain the documentation in a manner that is easy to consume and share. • Assist / coach Technical Writers with project schedule development and execution. • Audit Content Developers information for content quality and accuracy. • Resolve day-to-day service information problems and customer inquiries. • Maintain the library of product support information as products change. • Write for re-use using XML authoring system. • Write effectively with translations in mind. • Develop and maintain up to date work procedures. Qualifications • College, university or equivalent technical experience is required. • Intermediate level of relevant experience required. Additional information from the manager: • This position falls under the Product Activity Group for Client. The need driving this position is that this is a growing group and they need more help. If someone does well in this role, they could be considered for a full-time opportunity. • Selected candidate will be assigned to 2 current applications to manage. They will be responsible for updates, version control and publishing of those apps. As new applications come in to the group, some of those may also be assigned to that person to manage. Additional Information To set-up an Interview. Please contact Himanshu Prajapat Contact # ************ Email- himanshu.prajapat(@)collabera.com

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: **********************************

Join Our Team We are seeking an experienced Grant Writer to support the hospital's philanthropic and strategic research initiatives. In this role, you will research, write, and submit compelling grant proposals to foundations, corporations, and government entities. You will work closely with Foundation leadership, hospital program staff, and finance to align funding needs with opportunities, manage reporting requirements, and maintain a comprehensive grants calendar. Job Overview As a Grant Writer, you will be responsible for researching potential funding sources, preparing and submitting proposals, and ensuring that post-award compliance requirements are met. You will collaborate with internal teams to gather information, track grants, and support the hospital's ongoing philanthropic efforts. Your efforts will directly contribute to the success of our strategic research and healthcare initiatives. What You Will Do * Grant Research: Identify and research potential funding opportunities from foundations, corporations, and government agencies. * Proposal Development: Write and submit grant proposals, letters of inquiry (LOIs), and required supporting documents. * Collaboration: Work closely with program staff, finance, and leadership to gather accurate, timely information for grant submissions. * Post-Award Compliance: Manage post-award compliance for grant reporting, ensuring that all necessary reports are submitted on time. * Record Keeping: Maintain accurate records of grants, donor files, and associated correspondence. * Grant Calendar Management: Maintain a master calendar of grant opportunities, deadlines, and reporting schedules. * Donor Acknowledgment: Ensure funders are acknowledged through newsletters, social media, and other communication channels. * Reporting and Budgeting: Collaborate with the data manager to ensure compliance with reporting, outcome measurements, and grant budgets. * Progress Reporting: Assist with progress reports and targeted program updates for grantors and other stakeholders. What You Will Need * Education: Bachelor's degree from an accredited college or university - Required * Experience: * Minimum of 5 years of grant writing experience with a proven track record of successful submissions - Required * Ability to meet deadlines and manage multiple projects simultaneously - Required * Proficiency in Microsoft Office and experience with donor software - Required * Familiarity with national and government grants - Required * Experience in healthcare or nonprofit fundraising - Preferred Keywords Grant Writer, Proposal Development, Healthcare Fundraising, Nonprofit Grants, Government Grants, Foundation Funding, Grant Compliance, Fundraising Strategy, Donor Engagement, Philanthropic Initiatives, Grant Reporting, Strategic Research, Healthcare Grants, Proposal Writing, Deadline Management.

The person will be responsible for authoring and managing proposals primarily for US Federal/State/Local and Public sector. This would also include providing support for proposal response efforts, supporting the Capture/Bid Manager in day-to-day proposal management activities. This position is located on-site in Pune, IN Responsibilities Create outline, author responses to create a compelling story for the sections related to standard company information, industry and technology assets, solution content, methodology and tools, project management etc. Create client-centric proposal responses aligned to the win themes and value proposition developed for the opportunity (RFI/PQQ/RFP/ITT/RFR, etc) Co-ordinate with multiple teams to source and consolidate relevant information Expert in drafting sections like resumes, past performance and others which requires creative writing Assist Bid Manager in developing and managing work plans, response structure, schedules, and milestone Maintain compliance matrix against the RFI/PQQ/RFP requirements Manage proposal documents and the flow of information to and from proposal participants, including managing the SharePoint site, and monitoring document version control Sets up meetings for proposal draft reviews Creating Knowledge repository, reusable artefacts and maintain it for latest and greatest data Should have played lead role in managing the end to end bid management and support activities for bids assigned Formatting and packaging final response document for submission Qualifications Required Minimum experience of 5 years in presales/proposal development/Proposal writing function including strong understanding primarily of Big Data, Analytics, Cloud, System Integration concepts and US Staffing Solid knowledge of developing proposals in response to Request for Proposals (RFPs), Task orders, Contract vehicles, Teaming arrangements and data calls Excellent written communication (High proficiency of English language and an ability to write grammatically accurate English) Analytical thinking, interpersonal effectiveness, and positive attitude Ability to manage multiple service requests at the same time at high speed to ensure timely completion of accurate deliverables Ability to effectively collaborate with key internal service providers for getting the required support in crafting winning proposals Must be comfortable working and interacting with senior management (internal and external customer) Have the ability to manage complex, multi-works team opportunities Excellent formatting and bid packaging skills MS Office (Word, PPT, Excel) BE/B. Tech or equivalent graduation degree Preferred US Federal/State/Local Government Experience preferred MBA (good to have) Shipley, APMP certification preferred. Federal Consulting Industry Experience Preferred About Us Perks of working at NetImpact Strategies Your health comes first - we offer comprehensive medical, dental, & vision insurance that starts the first of the month after you join the team Invest in your future - 401(k) Plan - Immediately vested employer contributions; no matching required Work hard, play hard - we offer a generous Paid Time Off (PTO) policy and observe ALL ten (10) federal holidays Pawsitively pawesome - Pet Insurance (because our little critters are part of our families, too!) Invest in your education - Tuition reimbursement, internal training programs, & company-sponsored industry certifications Be part of a dynamic and collaborative work environment recently ranked by The Washington Post as a Top Work Place in 2019, 2021,2022, & 2023! Have fun and celebrate and give back - Team building activities, community volunteering, quarterly HQ days, & an offsite annual awards banquet ABOUT US NetImpact Strategies Inc. (NetImpact) has been a Trusted Advisor driving impact through digital transformation for the Federal Government for over a decade. We solve complex problems with innovation and agility to create meaningful, transformative, and enduring change. As Trusted Advisors, NetImpact professionals partner with customer agencies to deliver solutions that empower them to not only meet their missions but also realize their strategic vision through agile, outcome-focused solutions addressing both strategic and tactical requirements. We design and implement comprehensive, tailored solutions that are both mindful of the client's culture and organizational dynamics. NetImpact's core values and commitment to a customer and results-oriented delivery approach has propelled our growth and enabled us to deliver impactful value across Strategic Consulting, Process Automation, Cloud, DevSecOps, Data and Analytics, and Cyber Security for the Federal Government. ACCESSIBILITY NOTE NetImpact Strategies is committed to complying with all applicable provisions of the Americans with Disabilities Act, as amended (“ADA”), and applicable state and local laws. It is NetImpact's policy not to discriminate against any qualified person or applicant with regard to any terms or conditions of employment on the basis of such individual's disability. Consistent with this policy of non-discrimination, NetImpact will provide reasonable accommodations to an individual with a disability, as defined in the ADA or applicable law, who has made NetImpact aware of his/her disability, unless doing so would cause undue hardship to NetImpact. If you are an applicant and need reasonable accommodation when applying for job opportunities within NetImpact, or request reasonable accommodation to utilize NetImpact's online employment application, please contact *******************************. EQUAL OPPORTUNITY EMPLOYER NetImpact is committed to the development of a creative, diverse, and inclusive work environment. In order to provide equal employment and advancement opportunities to all individuals, employment decisions at NetImpact will be based on merit, qualifications, and abilities. NetImpact does not discriminate against any person because of race, color, creed, religion, sex (including gender identity, sexual orientation, and pregnancy), marital status, national origin, disability, age, veteran status, genetic information or any other characteristic protected by federal, state, and local laws (referred to as "protected status"). We can recommend jobs specifically for you! Click here to get started.

Internship Description Ruoff Mortgage is looking for a Copywriter Intern for Summer 2026. Our internship program runs from Wednesday, May 20th - Friday, August 7th. This role supports the Marketing team by creating and refining written content across campaigns, digital platforms, internal resources, and customer-facing communications. Working under the guidance of a copywriting mentor, the intern assists with brainstorming campaign concepts, editing copy from the Design team, and writing new content to support business needs. This role also contributes to maintaining website quality by auditing pages for clarity, tone, and accuracy. The intern will collaborate with IT to update help manuals and write copy that explains new software features, as well as draft blogs and posts for external channels. Essential Responsibilities Brainstorm and develop copy concepts for marketing campaigns to support brand messaging and promotional initiatives. Review, edit, and proofread copy on design assets to ensure accuracy, clarity, and consistency with brand standards (essential for compliance and clear communication). Write new copy for design requests, including materials needed by Loan Officers, to support marketing and customer outreach. Audit website content for grammar, spelling, tone, and completeness to maintain accessibility and user understanding. Collaborate with IT and a mentor to draft help manual content explaining new features in company apps and software, ensuring information is clear and usable for both internal employees and external clients (critical for product understanding and user assistance). Write and draft blog articles for The Porch, as well as Google Business Profile posts, social media content, and email messaging to assist Loan Officers' marketing efforts. Assist with other writing, editing, or content-related tasks as assigned. Knowledge, Skills and Abilities Strong writing, editing, grammar, and proofreading skills. Ability to adapt tone and style for different audiences and platforms. Creative thinking and idea generation for campaigns and content pieces. Strong attention to detail and commitment to accuracy. Ability to manage multiple assignments, prioritize deadlines, and work both independently and collaboratively. Familiarity with digital content practices, including SEO basics, is helpful but not required. Solid communication and interpersonal skills for working with cross-functional teams. Requirements Experience and Training Currently pursuing coursework in Marketing, Communications, English, Journalism, or a related field. Experience writing for class projects, student media, blogs, or previous internships is a plus but not required. Basic understanding of marketing principles or digital content creation is beneficial. Curiosity, willingness to learn, reliability, and a proactive attitude toward receiving and applying feedback. Strong organizational habits and professionalism in meeting deadlines and managing requests. Physical Demands and Work Environment Physical Demands: While performing the duties of this job, the employee is occasionally required to walk; sit; reach with hands and arms; stoop; talk and hear. Specific vision abilities required by the job include close and distance vision, peripheral vision and the ability to adjust focus. Occasionally lift, carry and/or move up to 25 pounds. Work Environment: Professional atmosphere in an open work environment Routinely uses office equipment such as computers, phones, photocopiers, filing cabinet and fax machine. Ruoff Mortgage Internship Program Details The Ruoff Mortgage Internship Program is designed to be engaging, hands-on, and rewarding. Throughout the summer, interns connect with leaders and peers through interactive Lunch & Learns, where they explore Mortgage 101, credit basics, department spotlights, and professional skills, plus weekly meetings focused on career readiness, leadership, and collaboration. Along the way, interns enjoy networking opportunities, community volunteer events, team outings, and wrap up the summer by showcasing their work in a group project presentation, making it a memorable and meaningful experience from start to finish! Ruoff Mortgage is an equal opportunity employer. Ideal candidates must be enrolled in an Indiana college or university, legally authorized to work in the U.S., and able to work in person at Ruoff Mortgage Corporate Headquarters in Fort Wayne, Indiana. Employment is subject to background and reference checks. While we thank all applicants for their interest, only those selected for interviews will be contacted.

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out ************************ Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene's high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Must Have You will be responsible for: Team Management & Coordination * Lead a team of 12 scientific editors, ensuring smooth execution of editorial tasks. * Plan and allocate daily tasks using a task tracker; monitor resource utilization. * Conduct daily team huddles to address challenges and provide support. * Set performance goals, conduct appraisal reviews, and identify training needs. Editorial Oversight & Quality Assurance * Guide the team on client-specific requirements and quality standards for copyediting. * Review content for writing quality, scientific accuracy, and client-appropriate style. * Standardize proofreading and editing processes across deliverables. * Communicate quality concerns from onshore editors to the reporting manager. Client & Stakeholder Engagement * Attend client meetings to support project planning and execution. * Serve as the point of contact for client communications with the offshore team. * Lead monthly copy editor meetings with clients, sharing feedback and concerns. * Support client-specific projects and provide timely data to project managers. Training & Development * Create and implement training plans for new hires, ensuring timely completion. * Train associates on client brands, deliverables, and editorial processes. * Identify skill gaps and provide remedial training as needed. * Participate in On The Job Training (OJT) sessions and mentor campus hires. Operational Support * Notify the team of process changes and send timely reminders for required actions. * Assist team members in stakeholder communication via email or preferred channels. * Evaluate editor tests and provide feedback to the reporting manager. * Proofread and review documents outside regular materials as per client requests. * Act as a backup offshore editor during client launches. Your impact: About you: * Master's degree in Life Sciences, English, Communications, or related field. * 7+ years of experience in scientific editing or medical writing, with at least 2 years in a lead role. * Strong understanding of scientific terminology and editorial standards. * Excellent communication, leadership, and organizational skills. * Proficiency in editorial tools and platforms (e.g., Veeva, MS Office). Must have: * Excellent written and spoken English skills * Strong attention to detail and accuracy * Proficiency in Microsoft Word, PowerPoint, and Adobe Acrobat * Familiarity with AMA Manual of Style and client-specific style guides * Ability to work under tight timelines and in a collaborative team environment * Strong communication skills (written and verbal) * Ability to guide and mentor team members * Proven track record of delivering high-quality, error-free documents Nice to have: * Experience in client-facing roles or participating in client calls * Experience in developing training materials and conducting training sessions * Involvement in continuous improvement initiatives * Ability to contribute to knowledge-sharing and documentation efforts Good to have EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate's merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.