Senior Medical Writer

LE1055 Perceptive Informatics, LLC; Massachusetts; À distance; USD 84 000 - 121 000; Plein temps

Avantages offerts par ce poste

Health benefits

Paid time off

401(k) & insurance

Résumé du poste

Perceptive Informatics, LLC is seeking a Senior Medical Writer for remote US-based work. You will create, research, edit and coordinate clinical documents related to independent review, serving as the client contact. The role focuses on information content authoring, project management and stakeholder engagement in regulated life sciences.

Proficiency with Microsoft Office and ICH-GCP is required. The annual base salary range is $84,368–$120,526, with benefits including health coverage, 401(k)

Qualifications

• Bachelor's degree in science, pharmacy, nursing or health-related field or equivalent experience.
• Fluent English (written and verbal).
• Experience in regulated life sciences environments and with ICH-GCP guidelines.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Experience using data analysis tools such as Tableau or Power BI.

Responsabilités

• Author, coordinate and finalize clinical documents for regulatory submission.
• Serve as primary client contact for medical writing projects.
• Ensure documents conform to SOPs and regulatory guidelines.
• Conduct literature searches to support document development.
• Review drafts and incorporate feedback from team members.
• Develop and implement process improvements for documentation workflows.

Connaissances

Communication

Written communication

Stakeholder management

Attention to detail

Multitasking

Critical thinking

Microsoft Office

Agile

Life sciences knowledge

Formation

Bachelor's Degree in a technical discipline

Outils

Tableau

Power BI

Description du poste

About Perceptive

Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster. We seek to change the world, and with the support of our teams across the globe, we flourish together. At Perceptive, we are one team. We learn, grow and win together. Are you ready to help change the world?

Apart from job satisfaction, we can offer you:

HEALTH:

• Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)

YOURSELF:

• Paid time off policy including holidays and sick time
• Internal growth and development programs & trainings

WEALTH:

401(k) program, life & accident insurance and disability insurance

About the role

A Senior Medical Writer will create, research, edit and coordinate the production of clinical documents related to independent review, including independent review charters, clinical data forms, manual case report forms, applicable reviewer training materials, project deviations and supplementary imaging reports, either independently or using available central content and templates. The medical writer will serve as a contact with clients.

Key Accountabilities:

Information Content authoring

Gather, review, analyze, and evaluate relevant resources to prepare, develop, and finalize applicable clinical documents for submission to regulatory authorities.

Prepare, develop, and finalize applicable clinical documents not intended for submission to regulatory authorities.

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.

Draft and/or ghost-write clinical documents for more experienced medical writers.

Act as support to others in the team to ensure that all documentation is accurate and encompasses all relevant information based on Stakeholder needs.

Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, central content, and general guidelines for clinical documentation and workflow procedures.

Initiate and participate in marketing initiatives, such as white paper, abstract, poster, and manuscript development.

Document Project Management

Serve as primary client contact for medical writing projects, negotiating deliverable timelines, and resolving project-related issues.

Serve as the medical writing representative on assigned project teams communicate content requirements, lead/facilitate authoring team meetings to agree on expectations.

Coordinate and conduct interdepartmental team reviews of draft and final documents, Evaluate progress on tasks, identify issues and facilitate resolutions, and advance document development to approval, according to Perceptive and/or client guidelines/SOPs.

Distribute final documents to project team and client in a timely manner and to agreed timescales.

Identify potential project challenges and raise with all relevant stakeholders, including changes in timelines or out of scope requests, and suggest possible resolution options.

Attend project team meetings as required.

Ensure appropriate filing of applicable project documentation.

May provide project management of contractual and financial aspects.

Relationship management

Implements stakeholder engagement/communications plan. Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information. Collects and uses feedback from customers and stakeholders to help measure effectiveness of stakeholder management. Helps develop and enhance customer and stakeholder relationships.

Quality management

Uses appropriate methods and a systematic approach in the development, maintenance, control and distribution documents. Prepares documents for publishing readiness, ensuring document consistency and integrity. Ensures documentation adheres to FDA/EMA or other appropriate regulatory guidelines, and / or relevant SOPs. Provides medical editing review of draft and final documents prepared by other medical writers before internal or external distribution. This includes both copyediting and content review. Follows required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable. Makes changes to and controls the updates and distribution of quality standards.

Relationship management

Implements stakeholder engagement/communications plan. Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information. Collects and uses feedback from customers and stakeholders to help measure effectiveness of stakeholder management. Helps develop and enhance customer and stakeholder relationships.

Other

Carryout any other reasonable duties as requested.

Skills:

Excellent interpersonal, verbal, presentational and written communication skills Ability to consistently produce documents of high quality A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Must have the ability to work methodically in a fast-paced, time-sensitive environment Demonstratable ability to apply critical thinking to problems and tasks Shows initiative and self-confidence, is adaptable and is able to cope with changing and evolving priorities Ability to identify and implement process improvements Proactively participates in skills improvement training and encourages their teams to participate Ability to negotiate on behalf of medical writing to ensure resources, timelines, and expectations are aligned Maintains an up-to-date awareness of trends, tools, technology, techniques, processes and documentation requirements that affect technology within the Life sciences domain A self-starter and able to work under own initiative Proven ability of using Microsoft Office products (including Word, Excel & PowerPoint) Knowledge and Experience: Experience using tools to communicate progress to Stakeholders Experience of regulated environments Understanding of Agile methodologies Experience of working in and knowledge of the life sciences sector Solid knowledge of industry guidelines and regulations, i.e., ICH-GCP. Experience of regulatory documents in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications. Solid Professional experience in the same or very similar role Experience using data analysis tools (e.g. Tableau, Power BI) desirable Proven ability of using Microsoft Office products (including Word, Excel & PowerPoint)

Education:

Bachelor's Degree in a technical discipline (Science, pharmacy, nursing, or other health-related discipline preferred etc.) or a related study, or equivalent project-related experience

English:

Fluent (written and verbal)

Non-English language:

desirable

This role is remote US based. Candidates located in the following states: AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, VA are preferred.

The annual base salary range for this role is $84,368-$120,526. This range represents the anticipated initial annual salary and will vary depending on several factors including the candidate's experience and skills as well as market rate adjustment.

Come as you are. We're proud to be an Equal Employment Opportunity employer.

We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

At Perceptive, we enable the world's pharmaceutical, biotech, and clinical research organizations to rapidly discover and advance life-changing treatments. Together, our global team delivers unmatched scientific and technological expertise, global operational experience, and end-to-end solutions to help the global research community realize tomorrow's new therapies. To do this, we need people like you. At Perceptive, your work will enable our customers to bring lifesaving and life-improving options to patients around the world. Learn how you can make a difference by joining our team and uniting under our shared goal - serving science to improve people's lives.

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