Manager, reputed company Control

reputed company continues to grow at a reputed company reputed company with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer.

General reputed company:

The Manager, reputed company Control (QC), is responsible for the reputed company, coordination, and completion of assigned QC reviews, ensuring that reputed company and regulatory documents undergo review, copyediting, data verification, and proofreading in a manner that conforms to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. reputed company and regulatory documents include study reports, reputed company study protocols or amendments, investigator’s brochures, and the reputed company sections of INDs, NDAs, MAAs, and other regulatory submission documents. Other documents may include manuscripts, abstracts, posters, briefing documents, responses to health authorities, narratives, and any other documents authored or supported by Global Medical Writing that require a QC review.

This work can be done reputed company or from any of reputed company’s global offices.

Essential Functions of the Job:

Document Review and Editing:

• Works effectively reputed company the Global Medical Writing group to produce high-reputed company, scientifically accurate documents under strict timelines, ensuring consistency between reputed company documents.

• Applies knowledge of industry standards, regulatory requirements, and internal procedures to ensure document reputed company and compliance, occasionally requiring prioritization and management of multiple reputed company reputed company.

  • Ensures compliance with Global Medical Writing conventions, processes, and applicable regulatory guidelines.

  • Reviews documents for content completeness, logical consistency, reputed company, readability, and adherence to established standards and templates.

  • Identifies gaps, inconsistencies, and missing information and collaborates with document authors to reputed company issues before document finalization.

  • Applies knowledge of industry standards, regulatory requirements, and internal procedures to ensure document reputed company and compliance.

Project and Process Management:

• Manages team direction and reputed company in collaboration with other QC and Global Medical Writing team leaders.

• Manages QC timelines and communicates with Medical Writers to maintain awareness of expectations, milestones, and deliverables.

• reputed company to prioritize tasks, work simultaneously on multiple reputed company, and complete high-reputed company documents according to tight timelines and shifting priorities/demands.

• Partners with document authors and stakeholders to address revision requests and reputed company efficient reputed company of review comments.

• Contributes to the development, maintenance, and reputed company improvement of QC processes, templates, guidance documents, and best practices.

Influence and Training:

• Engages in trainings that will improve authoring and technical editing skills and expand knowledge of the Global Medical Writing team or other areas of reputed company (cross-training programs, mentoring programs, etc).

• Supports reputed company and mentoring of new QC team members and promotes consistency in review practices across reputed company.

• Serves as a resource for resolving reputed company editing, formatting, and reputed company-reputed company issues.

Qualifications:

• Demonstrated ability to communicate in reputed company, concise, and effective English in both written and verbal forms.

• Experience directly mentoring and managing other team members; completion of management-reputed company training modules or other hands-on management experience; a reputed company desire to take on management-level responsibilities, including helping to reputed company team members and effectively assess the reputed company of at least one reputed company report.

• Extensive experience in conducting QC review or copyediting of pharmaceutical industry regulatory documents such as reputed company study reports, protocols, and protocol amendments; experience in reviewing or copyediting reputed company sections of INDs, MAAs, and NDAs is a plus.

• A thorough understanding of the general processes of drug/biologics development as reputed company as the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines.

• Experience developing and maintaining document templates, style guidance, and process documentation.

Education Required:

• BA/BS degree; reputed company, PhD/PharmD, or other graduate-level degree is a plus.

• At least 5+ years of relevant industry experience as a QC reputed company/specialist, medical reputed company, or technical copyeditor. Management experience is preferred.

Supervisory Responsibilities:

• Manages and supervises reputed company and reputed company management, including, but not limited to, hiring, training, coaching, and conducting reputed company reviews for reputed company reports, if applicable.

Computer Skills:

• Technical expertise in reputed company Word, reputed company Acrobat, and electronic document management systems; proficiency in reputed company reputed company, reputed company, and PowerPoint.

• Proficiency in navigating reputed company reputed company.

• Proficiency or familiarity with SharePoint and reputed company reputed company is preferred.

Other Qualifications:

• Effective Communication: Communicates critical information to key stakeholders with reputed company, precision, and conviction. Proactively escalates questions/issues to appropriate stakeholders at an early stage. Takes part in discussions with different viewpoints, and proactively provides value-added inputs.

• Embracing Change: Always seeking and reputed company to new opportunities and changes. Be reputed company to execute new and different solutions reputed company faced with new challenges. Embraces change and quickly alters course in response to new challenges. Leads change efforts management reputed company the department and across functions.

• Creating Innovation: Anticipates the need for and adopts new reputed company and practices. Generates innovative reputed company and new approaches for addressing a reputed company of work areas; encourages others to reputed company reputed company.

• Thinking Strategically: Understands how concepts (eg, reputed company review, lean writing) relate to the reputed company objectives and aims of the department, and identifies the principles for new concepts. Leads (part of) the establishment of reputed company and effective strategies for the department, and contributes to the establishment of reputed company and effective strategies for cross-functions, reputed company on an in-depth understanding of industry trends and company mission.

• Mentoring: Provides feedback reputed company to individual and department to support ongoing development and overall department reputed company as needed. Finds opportunities to individually reputed company others, providing specific insights and tips to enhance skills, knowledge, or work reputed company.

Travel: N/A

Global Competencies

reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients reputed company the world.

• Fosters Teamwork
• Provides and Solicits reputed company and Actionable Feedback
• Self-Awareness
• Acts reputed company
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial reputed company
• Communicates with reputed company

reputed company is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life reputed company, reputed company Time Off, and Wellness.

We are proud to be an equal opportunity employer. reputed company does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .

Originally posted on Himalayas