Principal Medical Writer (Ft Remote)

SPAULDING CLINICAL aims to be the clinical research organization by which all others are measured. Pioneering in our approach to redefining how the industry perceives and achieves success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for our volunteers, customers and employees; and heroic in our ambitions to ensure the health and safety of people around the globe - Spaulding Clinical is taking research beyond results to create a marketplace of safer drugs.

Position Snapshot:

• Full Time
• Remote
• Health, Dental, Vision, Supplemental Life, 401k, PTO, Holiday Pay, and Bonus Program

Job Summary:

The Principal Medical Writer will be responsible for the writing and editing of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of a clinical program.

Essential Duties and Responsibilities:

• In collaboration with clinical and regulatory, manages the authoring and document life cycle of clinical protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), electronic Common Technical Document (eCTD) summaries and other documents for submission to the Food and Drug Administration (FDA) or other regulatory agencies.
• Compiles, analyzes, and summarizes data from statistical tables and other sources, as needed.
• Liaises with cross-functional team members (e.g., clinical operations, clinical science, regulatory affairs, biostatistics, nonclinical) to ensure that information is accurately captured in documents.
• Coordinates and/or performs document reviews.
• Acts as the medical writing representative for multiple concurrent studies
• May work with medical writing contractors on studies while ensuring consistency in messaging across a program.
• Participates in the development/update of departmental procedures and templates.
• Other duties as needed.
• May participate in proposal development
• May participate in the bid-defense process with guidance and supervision

The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Skills/Qualifications:

• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in documents.
• Good understanding of common statistical methods used in clinical trials and interpretation of their results.
• Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
• Extensive experience in preparing CSRs and protocols independently to a consistently high standard, regardless of complexity or challenges.
• Experienced in preparing CTDs and tackling new or unusual document types and customer requirements.
• In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.
• Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
• Experienced and effective in providing feedback and guidance to more junior staff.
• Ability to effectively manage multiple tasks and projects. Decisive amongst competing priorities.
• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers. Confidence in appropriately challenging the customer when document quality or timelines are at risk.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Specific vision abilities required by this job include clarity of vision both near and far.
• Ability to identify and distinguish colors.

Hazards:

• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens

Education and Experience:

• Bachelor's Degree in life sciences related discipline or related field is Required.
• Understanding of clinical research GCP regulations, processes, and procedures
• At least 5 years of highly relevant experience and related competency levels, including extensive experience in preparing CSRs and protocols independently to a consistently high standard.
• Experience as lead writer for key documents including FDA and international regulatory submissions required
• Clear understanding of clinical development, including phases, processes, and techniques used within a clinical development area from protocol design through regulatory submission

Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.

We are an equal opportunity employer. Spaulding Clinical does not discriminate on the basis of race, religion, sexual orientation, gender identity, age, marital status, national origin, veteran status, disability, or any other basis covered by appropriate law. All aspects of employment are decided on the basis of merit, qualifications, and business need. Simply put, we celebrate diversity in all forms and have zero tolerance for discrimination, harassment, or plain hate.