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Description

Development and execution of various high-quality medical-writing initiatives across all therapeutic areas within Research and Development. Active collaborator with local and global cross-functional program teams for devices, drugs, biologics, and/or other products for human use, with projects spanning from development to post marketing. Responsible for ensuring documents are written in accordance with guidelines, SOPs, and applicable regulations. Responsible for leading writing projects, as well as managing and mentoring junior-level medical writer(s) (if applicable).

Essential Duties and Responsibilities

Author various clinical and technical documents (e.g., clinical study protocols, clinical study reports, investigator brochures, manuscripts, etc.):

• Author high-quality clinical documents, contributing scientific/technical expertise, knowledge related to clinical development, and experience related to document preparation.
• Analyze, synthesize, and incorporate relevant clinical/medical literature into documents.
• Communicate with and work effectively and productively with multidisciplinary, international teams while executing project plan.
• Act as medical writing subject matter expert on clinical study teams.
• Ensure documents comply with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practice, and internal policies and procedures.
• Independently identify document-content issues and resolve/implement or escalate for resolution.
• Coordinate the review, approval, submission, and production of final documents in accordance with established timelines.
• Coordinate with team leads to plan resource needs and timelines for high-quality, properly formatted medical writing deliverables.

Review, edit, and approve clinical and technical documents:

• Evaluate documents for organization, clarity, language/grammar, consistency, and scientific standards.
• Ensure document deliverables are clear, concise, and adherent to guidelines, SOPs, and applicable regulations.
• Provide expert advice to project teams on matters related to production of clinical documents, regulatory submissions, and/or presentations/publications.

Evaluate, interpret, and synthesize scientific / medical data and information:

• Coordinate and integrate data and information from a variety of sources, including clinical study data and study results (i.e., tables, figures, and listings) and peer reviewed literature to support various clinical initiatives.
• Consolidate input from internal and external contributors to develop appropriate/key document messaging.
• Establish general proficiency of applicable therapeutic area, gathering relevant product knowledge for application in assigned projects.

Support writing initiatives with Medical Affairs:

• Provide medical writing and editing expertise, liaising with internal and external authors, to develop complex scientific manuscripts, abstracts, posters, oral presentations, and other printed materials to support the scientific communication of Merz products.
• Maintain current awareness of good-publication practices, editorial policies, and journal-specific guidelines and apply to publishing projects.
• Create figures and tables for publications that effectively communicate the data and adhere to journal/congress requirements.

Support writing initiatives with Regulatory Affairs:

• Provide medical writing and editing expertise for regulatory-submission documents (e.g., clinical study protocols, clinical study reports, investigator brochures, meeting packages, IND/IDE applications, sections of marketing applications [NDA/MAA/CTD], patient information guides, instructions for use, and pharmacovigilance documents).

Provide oversight of external medical-writing vendors:

• Effectively manage all assigned medical-writing projects, including projects outsourced to vendors.
• Manage planning of assignments and evaluation of deliverables from contractors.
• Review and edit work of contract writers to ensure Merz SOPs are followed, correct document templates are used, and quality is maintained.

Support organizational development, compliance, and training: 

• Participate in the development, improvement, and optimization of internal processes (e.g., workshops, taskforces, SOPs, work instructions, etc.), working toward efficiency and consistency.
• Develop and implement training for medical writers and mentor junior staff members and ensure staff adheres to Merz standards (if applicable).

Job Related Qualifications/Skills

Professional Experience

Required:

• At least 3 years of medical-writing experience in the pharmaceutical, medical device, health sciences, or biotech industry
• Demonstration of strong medical-writing skills (e.g., peer-reviewed publications, IND/NDA modules, IDE/PMA submissions, investigator brochures, study protocols, CSRs)

Preferred:

• American Medical Writing Association (AMWA) or other medical-writing certification

Knowledge, Skills, and Abilities

Required:

• Excellent verbal and written English, including understanding of English language usage and standardized-writing styles
• Ability to work autonomously in most situations, apply previous experience, and best practice knowledge
• Strong interpersonal and teamwork skills
• Able to work on multiple projects simultaneously, while maintaining competing priorities, timelines, and quality of deliverables
• Able to anticipate obstacles and proactively develop solutions to achieve project goals
• Readily adaptable to changes in priorities
• Knowledge of FDA and/or EMA regulations, GCP, ICH guidelines, and/or ISO 14155
• Understanding of clinical product development, clinical trials, and global regulatory submissions
• Able to engage in an open, constructive, and continuous dialogue
• Able to travel (minimal domestic/international travel for company meetings and conferences)
• Able to develop solutions to complex problems that are consistent with company objectives

Knowledge of Methods

Required:

• Experienced user of Microsoft applications (e.g., Word, PowerPoint, Excel, SharePoint)
• Experience in medical-database searches (e.g., Medline, PubMed)

Preferred:

• Experience with document-review software/platforms (e.g., PleaseReview, Documentum) and Sharepoint
• Experience with reference manager software (e.g., EndNote)
• Experience in working with templates and style guides

Personal Skills

Required:

• Sound organizational and planning skills; deadline-oriented and meticulous in approach; possess a sense of urgency, accuracy, and attention to detail
• Able to work independently and proactively
• Solid work ethic, professionalism, and sense of responsibility and personal accountability
• Strong ability to work collaboratively and to respect other working cultures
• Team player with strong communication and presentation skills
• Prefers quality over quantity and is dependable

Education

Required:

• Master’s Degree in Science with relevant writing experience

Preferred:

• PhD or DrPH

Pay Range

• 91,000 - 135,000k

Position Working Hours:

• This position is remote; however, being able to work an Eastern Standard Time schedule is preferred.

Behaviours

Motivation

Education

Experience

Licences & certifications