Senior copywriter jobs in Rhode Island

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.

WJAR is seeking an detail oriented, aggressive, energetic, and creative full-time News Assignment Editor! Skills and Experience: Assign and track news crews Identify and develop daily content Write and post content to station website and social media sites Compelling and accurate writing Listen to scanners and react to breaking news, make beat checks, monitor web sites and social media, react to developing news Develop and maintain contacts and sources to enterprise story ideas Listen for and respond to breaking news Assisting in the efficient operations of the assignment desk Requirements and Qualifications: Minimum of 1 year of assignment desk experience Commitment to journalistic standards of ethics and accuracy Ability to communicate effectively Basic computer knowledge/word processing skills General knowledge and interest in local, national and world news Ability to work well under pressure and meet deadlines Proficiency with Facebook, Twitter and emerging social media platforms Bachelor's degree with a major in journalism is also preferred EEO AND INCLUSIVITY: Sinclair is proud to be an equal opportunity employer and a drug free workplace. Employment practices will not be influenced or affected by virtue of an applicant's or employee's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, military or veteran status or any other characteristic protected by law.

The Grant Specialist plays a key role in supporting both internal stakeholders and the Sponsored Programs Office by guiding the development of strong, competitive proposals. This role ensures every submission meets sponsor and Care New England (CNE) requirements, while also maintaining meticulous documentation of proposals and approvals prior to portal submission. Beyond proposal development, the Grant Specialist oversees the fiscal, administrative, and regulatory management of grants, contracts, and sponsored programs from award receipt all the way through closeout. Collaborating closely with both internal and external partners, this position delivers comprehensive pre- and post-award services to ensure the success of funded projects. The ideal candidate thrives in a fast-paced, deadline-driven environment skilled at balancing competing priorities, taking initiative, and applying sound judgment with a keen eye for detail. Strong communication skills, both written and verbal, are essential. Additional responsibilities may be assigned in alignment with the evolving needs and strategic goals of the department and the broader CNE system. Duties and Responsibilities: Manage pre- and post-award activities, including proposal development, budget preparation, award management, and compliance monitoring Apply critical thinking, problem solving, and independent judgment to support interdisciplinary teamwork Maintain accurate records and ensure adherence to sponsor, CNE, and departmental policies and regulations Communicate effectively, both orally and in writing, with diverse stakeholders in an inclusive and collaborative environment Demonstrate proficiency with Microsoft Office and data entry; experience with research administration systems and federal portals (e.g., grants.gov) preferred Interpret and apply funding announcements, award terms, contract clauses, cost principles, and reporting requirements Coordinate and monitor sub-recipient agreements and prior approval requests Provide guidance to departments on sponsored projects and serve as a resource on federal, industry, state, and non-profit requirements Engage in professional development to support continuous growth Demonstrate a working knowledge and solid understanding of the practices/procedures related to (not all-inclusive): Uniform Guidance, 2 CFR 200, Federal Acquisition Regulations, 45 CFR 75 National Institutes of Health Grants Policy Statement Department of Health and Human Services Grants Policy Statement Other federal grant policies as needed (e.g., NSF PAPPG in rare circumstances) CNE and department policies and procedures Requirements: Bachelor's degree or a minimum of 10-years of relevant work experience is required. Care New England Health System (CNE) and its member institutions, Butler Hospital, Women & Infants Hospital, Kent Hospital, VNA of Care New England, Integra, The Providence Center, and Care New England Medical Group, and our Wellness Center, are trusted organizations fueling the latest advances in medical research, attracting the nation s top specialty-trained doctors, and honing renowned services and innovative programs to engage in the important discussions people need to have about their health. Americans with Disability Act Statement: External and internal applicants, as well as position incumbents who become disabled must be able to perform the essential job-specific functions either unaided or with the assistance of a reasonable accommodation, to be determined by the organization on a case-by-case basis. EEOC Statement: Care New England is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status Ethics Statement: Employee conducts himself/herself consistent with the ethical standards of the organization including, but not limited to hospital policy, mission, vision, and values.

Information Posting Number SF01977 Job Title Editor Position Number 109948 FTE 1.00 FLSA Exempt Position Type Professional Staff Union PTAA - Professional/Tech/Admin Assoc Pay Grade Level Grade Level: 11 Pay Grade Range Anticipated Hiring Salary Range: $65,000 - $70,000 Status Calendar Year, Full-time, Permanent Department Information Department Communications and Marketing Contact(s) Please note: Job applications must be submitted directly online only at: (********************* Contact Phone/Extension Contact Email Physical Demands Campus Location Kingston Grant Funded No Extension Contingency Notes Job Description Summary The search will remain open until the position has been filled. First consideration will be given to applications received by March 31, 2025. Applications received after March 31, 2025 may be reviewed depending on search progress and needs but are not guaranteed full consideration. _______________________________________________________________________________________________________ About URI: The University of Rhode Island enrolls approximately 17,000 students across its graduate and undergraduate programs and is the state's flagship public research university, as well as the land- grant and sea-grant university, for the state of Rhode Island. The main campus is located in the historic village of Kingston, and the Bay Campus is located in Narragansett. Both campuses are near major beaches in a beautiful coastal community. URI is just 30 minutes from Providence, R.I., and within easy reach of Newport, Boston, and New York City. ________________________________________________________________________________________________ This is a full time in person position with a hybrid/remote schedule of 2 days a week possible immediately upon start date with supervisors permission. BASIC FUNCTION: Work as part of the Publications and Creative Services team in a collaborative and deadline-driven environment to produce high-quality print and digital/online university materials, including managing production from inception to delivery. Work with university constituents and departments to maximize marketing and communications outreach efforts that meet strategic objectives. Set the editorial vision and voice for university publications/materials and develop content that resonates with diverse audiences, including prospective and current students, faculty, alumni, and community stakeholders. Ensure the timely delivery of communication and marketing publications/materials that enhance stakeholders' understanding of the university's mission and uphold the university's brand and editorial standards. Duties and Responsibilities ESSENTIAL DUTIES AND RESPONSIBILITIES: Manage multiple projects simultaneously and serve as project lead, initiating contact with university clients and collaborating with Publications and Creative Services production coordinator, designers, and photographer to ensure timely adherence to production schedules. Organize and present content and guide the content selection process. Proofread, fact-check, and edit copy for clarity, grammar, and accuracy. Coordinate university messaging and contribute to campaign planning in collaboration and consultation with other marketing and communications staff, including brand marketing and advertising, social media, web communications, public information/media relations, and alumni magazine. Working within client budget parameters and adhering to URI and state of Rhode Island purchasing regulations, write job production specifications, solicit bids/quotes, and select vendors. OTHER DUTIES AND RESPONSIBILITIES: Support the editor-in-chief of the University of Rhode Island Magazine (alumni publication), serving as copy editor and proofreader as assigned. Serve as a creative partner with graphic design staff to set, execute, and achieve client objectives. Write and coordinate other editorial jobs for Publications and Creative Services, as assigned. Perform additional duties as requested. LICENSES, TOOLS, AND EQUIPMENT: Personal computers (Macintosh hardware), printers, and relevant digital programs and software. Required Qualifications REQUIRED: 1. Bachelor's degree. 2. Minimum of five years of demonstrated professional editing and writing experience. 3. Demonstrated strong skills in grammar, spelling, punctuation and editing conventions. 4. Demonstrated experience seeking and developing content. 5. Demonstrated experience executing print and online strategies to maximize communications. 6. Demonstrated project management or project leadership experience. 7. Demonstrated ability to handle multiple priorities simultaneously in a fast-paced, deadline-driven environment. 8. Demonstrated organizational skills. 9. Demonstrated strong verbal and interpersonal communication skills. 10. Demonstrated proficiency in written communication skills. 11. Demonstrated ability to collaborate with a variety of stakeholders. 12. Demonstrated ability to work as a member of a team. 13. Demonstrated ability to work with diverse groups/populations. Preferred Qualifications PREFERRED: 1. Bachelor's degree in English, journalism, communications, or related field. 2. Demonstrated professional editing, writing, and communications project management experience at an institution of higher education. 3. Demonstrated experience working with Web-based and email marketing platforms. ______________________________________________________________________________________________ The University of Rhode Island is an equal-opportunity employer. It is the policy of the University of Rhode Island to provide reasonable accommodation when requested by a qualified applicant or employee with a disability. Environmental Conditions This position is not substantially exposed to adverse environmental conditions. Posting Date 03/14/2025 Closing Date Special Instructions to Applicants Please attach the following 4 (PDF) documents to your online Employment Application: (#1) Cover letter. (#2) Resume. (#3) Other Document - 3 to 5 samples of related work (as one complete pdf document or a link provided within a pdf document). (#4) Other Document - References - the names and contact information of three professional references. (Note: this document is required even though references may be listed on the application). Quicklink for Posting ***********************************

Rhode Island School of Design (RISD) seeks a Senior Writer, Advancement Communications to join Institutional Advancement. The Senior Writer, Advancement Communications, plays a key role in crafting compelling content that supports philanthropic goals and engagement efforts at Rhode Island School of Design (RISD). Rooted in RISD's creative culture, this role calls for an exceptional writer who can blend strategic thinking with imaginative storytelling to effectively communicate the impact of art and design education. Reporting to the Executive Director of Advancement Communications within Institutional Advancement (IA), the Senior Writer collaborates with colleagues across fundraising, donor relations, and alumni and family relations to develop a wide range of high-quality materials. These include major gift opportunities, cases for support, stewardship reporting, annual giving materials, fundraising collateral and more. The Senior Writer will also contribute to key IA publications, including the RISD Alumni + Friends Magazine. The ideal candidate is detail-oriented, collaborative, and deadline-driven. The Senior Writer brings strong writing and editorial skills, a clear and adaptable voice and an understanding of how to tailor messages to diverse audiences. The successful candidate will thrive in a campus environment that is committed to advancing the principles of social equity and inclusion, environmental and climate justice, and equal access to resources and opportunities. Essential Functions: Develop a strong understanding of RISD's strategic priorities across the college, museum, and institution-wide initiatives, and translate them into clear, audience-specific content for a variety of communication channels. Work with fundraisers and senior leadership to develop materials that effectively convey the need for philanthropic support and demonstrate the impact of giving. Write and produce cohesive, high-quality content that supports IA's goals. This includes, but is not limited to, stewardship reports, donor acknowledgements, solicitations, fundraising collateral, gift announcements, and talking points, etc. Edit and proofread a wide range of IA communications and materials prepared for external audiences to ensure clarity, consistency and accuracy. Collaborate closely with colleagues across IA to strategize, develop, and implement content that supports fundraising and engagement goals. Identify opportunities to tell meaningful stories that highlight donor impact and build compelling cases for support. Required Knowledge/Skills/Experience Bachelor's degree with at least 5-7 years of relevant experience in donor relations or philanthropy communications. Must be a superb writer, editor, proofreader and researcher: fast, creative, curious, detail-oriented and versatile Experience in creative writing at all gift levels in a nonprofit setting, higher ed preferred. Ability to gather and synthesize large quantities of information, organize ideas and turn institutional objectives and messages into compelling cases for philanthropic support and engagement. Flexibility and ability to receive edits and adjust work, incorporating feedback Ability to produce high-quality work in a timely manner, adhering to deadlines while managing and prioritizing multiple projects. Demonstrated ability to engage as a positive team member who establishes productive relationships, demonstrates respect and facilitates understanding by considering and integrating diverse viewpoints; ability to work both independently and as part of a team. Occasional travel or event attendance, sometimes outside of regular business hours, to learn about fundraising priorities. Preferred Qualifications: Relevant experience and knowledge of higher education fundraising and methods of institutional advancement and fundraising. Knowledge of current and evolving advancement communications concepts, as well as shifting donor relations practices. Experience with annual giving and direct response marketing. Union: No Work Schedule: 35 hours per week; 12 months per year Employment Status: Full-time; Exempt; Regular Grade: 540EX Work Modality Hybrid Eligible Documents Needed to Apply: -Resume (Required) -Cover Letter (Required) -Please submit two writing samples as either a PDF or Word Doc that demonstrate your ability to communicate with philanthropic audiences: A donor-facing piece (e.g., solicitation, stewardship report excerpt, gift announcement, case-for-support section), approximately 300-600 words. A narrative or storytelling piece that highlights impact (e.g., donor profile, student story, program feature), approximately 500-900 words. Samples may be previously published or created in a professional context. If submitting a newly created sample, it should be a short piece written for a higher-education, arts, or mission-driven nonprofit context. The sample does not need to be RISD-specific. Applicants may choose a comparable institution or organization. Please redact any confidential information. If you have any questions about the format of your submission, please reach out to ***************. Salary Grade Structure Incomplete applications will not be considered. Please upload all required documents. The successful candidate will be required to meet our pre-employment background screening requirements. RISD recognizes diversity and inclusivity as fundamental to its learning community and integral to an art and design education. We welcome candidates whose experience has prepared them to contribute to our commitment to diversity and excellence. RISD is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity or expression, genetics, or any other protected characteristic as established by law. For internal use only - Job Family: Marketing - Media

EMPLOYER Submission Deadline Wednesday, May 20, 2020

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.

The Grant Specialist plays a key role in supporting both internal stakeholders and the Sponsored Programs Office by guiding the development of strong, competitive proposals. This role ensures every submission meets sponsor and Care New England (CNE) requirements, while also maintaining meticulous documentation of proposals and approvals prior to portal submission. Beyond proposal development, the Grant Specialist oversees the fiscal, administrative, and regulatory management of grants, contracts, and sponsored programs from award receipt all the way through closeout. Collaborating closely with both internal and external partners, this position delivers comprehensive pre- and post-award services to ensure the success of funded projects. The ideal candidate thrives in a fast-paced, deadline-driven environmentskilled at balancing competing priorities, taking initiative, and applying sound judgment with a keen eye for detail. Strong communication skills, both written and verbal, are essential. Additional responsibilities may be assigned in alignment with the evolving needs and strategic goals of the department and the broader CNE system. Duties and Responsibilities: Manage pre- and post-award activities, including proposal development, budget preparation, award management, and compliance monitoring Apply critical thinking, problem solving, and independent judgment to support interdisciplinary teamwork Maintain accurate records and ensure adherence to sponsor, CNE, and departmental policies and regulations Communicate effectively, both orally and in writing, with diverse stakeholders in an inclusive and collaborative environment Demonstrate proficiency with Microsoft Office and data entry; experience with research administration systems and federal portals (e.g., grants.gov) preferred Interpret and apply funding announcements, award terms, contract clauses, cost principles, and reporting requirements Coordinate and monitor sub-recipient agreements and prior approval requests Provide guidance to departments on sponsored projects and serve as a resource on federal, industry, state, and non-profit requirements Engage in professional development to support continuous growth Demonstrate a working knowledge and solid understanding of the practices/procedures related to (not all-inclusive): Uniform Guidance, 2 CFR 200, Federal Acquisition Regulations, 45 CFR 75 National Institutes of Health Grants Policy Statement Department of Health and Human Services Grants Policy Statement Other federal grant policies as needed (e.g., NSF PAPPG in rare circumstances) CNE and department policies and procedures Requirements: Bachelor's degree or a minimum of 10-years of relevant work experience is required. Care New England Health System (CNE) and its member institutions, Butler Hospital, Women & Infants Hospital, Kent Hospital, VNA of Care New England, Integra, The Providence Center, and Care New England Medical Group, and our Wellness Center, are trusted organizations fueling the latest advances in medical research, attracting the nations top specialty-trained doctors, and honing renowned services and innovative programs to engage in the important discussions people need to have about their health. Americans with Disability Act Statement: External and internal applicants, as well as position incumbents who become disabled must be able to perform the essential job-specific functions either unaided or with the assistance of a reasonable accommodation, to be determined by the organization on a case-by-case basis. EEOC Statement: Care New England is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status Ethics Statement: Employee conducts himself/herself consistent with the ethical standards of the organization including, but not limited to hospital policy, mission, vision, and values.

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