Associate Manager, Quality Control and Editing

Job Description Summary:

The Associate Manager, Quality Control Review and Editing provides technical and operational support for the development of high-quality documents for regulatory fulfillment to health authorities and associated projects. This includes reviewing and editing documents for regulatory submissions such as clinical, nonclinical, and chemistry manufacturing and control (CMC) content and presentations, posters, and publications.
The Associate Manager, Quality Control Review and Editing works cross-functionally with internal departments and external resources to lead and contribute to quality control (QC), editing, and Global Regulatory Affairs–related projects.

Job Description:

Responsibilities:

• Working with project teams, under strict timelines, conducts editing and/or QC review (data verification against source documents and internal consistency checks) of complex regulatory documents including, but not limited to, clinical study reports (CSRs), protocols, briefing documents, Investigator’s Brochures (IBs), submission modules, and nonclinical study protocols and reports.
• Provides editorial and/or QC support for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals.
• Ensures timely completion/delivery of high-quality reviews.
• Ensures a consistent style of document presentation to maintain quality and ease of review and adherence to company standards.
• Trains and acts as a go-to resource for other editors/QC reviewers.
• Leads and plays a key role in improving, developing, and implementing Quality Control Review and Editing processes and best practices.
• Coordinates with external editing and QC review resources (eg, vendors/consultants).
• Assists with day-to-day operational activities and other assignments as needed and specified by management.

Qualifications:

• Bachelor’s degree or higher and a preferred minimum of 3 years of direct editing and/or document QC review experience in a pharmaceutical, biotechnology, or related environment.
• Excellent attention to detail, including consistency, logical flow, adherence to style, and document structure.
• Demonstrated experience in editing and/or QC review of clinical regulatory documents, such as protocols, clinical study reports, submission modules, and Investigator’s Brochures.
• Proficiency with Microsoft Office, use of electronic document templates, and a strong aptitude for effectively utilizing technology.
• Experience with IND and NDA or MAA submissions.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Proactive, creative, and solution-oriented when creating processes, working on projects, and working cross-functionally.
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects and to complete high-quality documents according to tight timelines.

*Special knowledge or skills and/or licenses or certificates preferred.

•             Management of QC/Editing projects and resources.

Travel requirements - 0-10%

Expected Base Salary Range:

$90,800 – 106,800. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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