BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Senior Quality Control Specialist, Medical Writing is responsible for the oversight, management, and coordination of all review, copyediting, and proofreading of clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical regulatory documents include, but are not limited to, study reports, clinical study protocols or amendments, investigator brochures, and the clinical sections of INDs, NDAs, MAAs and other regulatory submission documents. This work can be done remotely, or from any of our US-based offices (Emeryville CA, San Mateo CA, Cambridge MA, Ridgefield Park NJ, Fulton MD) Essential Functions of the job: Works effectively within the Global Medical Writing department to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents Responsible for performing a quality check of clinical regulatory documents before approval Proofread documents for grammatical errors, formatting errors, hyperlink functionality, data source verification, and proper translation of data Perform cross-referencing, fact-checking, and general quality assessments of documents Manage timelines and communicate with Medical Writers to maintain awareness of expectations, milestones, and deliverables Review and edit documents written within BeiGene, as well as those authored externally Ensure compliance with Medical Writing conventions, processes, and applicable regulatory guidelines Qualifications: Knowledge and Skills Demonstrated ability to communicate in clear, concise, and effective English in both written and verbal forms Strong project management skills: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands Maintain consistent attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing high volume, repetitive tasks Independently motivated with good problem-solving ability Excellent interpersonal skills; a team player Extensive experience in conducting QC review or copy editing of pharmaceutical industry regulatory documents such as clinical study reports, protocols, and protocol amendments; experience in reviewing or copy editing clinical sections of INDs, MAAs, and NDAs is a plus A thorough understanding of the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines Working knowledge of the development of drugs and biologics (ie, clinical study design, biostatistics, regulatory affairs, and medical terminology) preferred Ability to ensure reviewed documents comply with company and/or industry style guides and templates Computer Skills Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint Education Required At a minimum, a BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus At least 3-5 years of relevant industry experience as a QC editor/specialist, medical writer or copyeditor Supervisory Responsibilities: The Senior QC Specialist may manage junior full-time employee (FTE) QC Specialists and/or QC contractors, as needed. Competencies: Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information. Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others. Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events. Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others. Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget.
BeiGene
Indianapolis Indiana
United States
Healthcare - Allied Health
(No Timezone Provided)
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Senior Quality Control Specialist, Medical Writing is responsible for the oversight, management, and coordination of all review, copyediting, and proofreading of clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical regulatory documents include, but are not limited to, study reports, clinical study protocols or amendments, investigator brochures, and the clinical sections of INDs, NDAs, MAAs and other regulatory submission documents. This work can be done remotely, or from any of our US-based offices (Emeryville CA, San Mateo CA, Cambridge MA, Ridgefield Park NJ, Fulton MD) Essential Functions of the job: Works effectively within the Global Medical Writing department to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents Responsible for performing a quality check of clinical regulatory documents before approval Proofread documents for grammatical errors, formatting errors, hyperlink functionality, data source verification, and proper translation of data Perform cross-referencing, fact-checking, and general quality assessments of documents Manage timelines and communicate with Medical Writers to maintain awareness of expectations, milestones, and deliverables Review and edit documents written within BeiGene, as well as those authored externally Ensure compliance with Medical Writing conventions, processes, and applicable regulatory guidelines Qualifications: Knowledge and Skills Demonstrated ability to communicate in clear, concise, and effective English in both written and verbal forms Strong project management skills: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands Maintain consistent attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing high volume, repetitive tasks Independently motivated with good problem-solving ability Excellent interpersonal skills; a team player Extensive experience in conducting QC review or copy editing of pharmaceutical industry regulatory documents such as clinical study reports, protocols, and protocol amendments; experience in reviewing or copy editing clinical sections of INDs, MAAs, and NDAs is a plus A thorough understanding of the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines Working knowledge of the development of drugs and biologics (ie, clinical study design, biostatistics, regulatory affairs, and medical terminology) preferred Ability to ensure reviewed documents comply with company and/or industry style guides and templates Computer Skills Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint Education Required At a minimum, a BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus At least 3-5 years of relevant industry experience as a QC editor/specialist, medical writer or copyeditor Supervisory Responsibilities: The Senior QC Specialist may manage junior full-time employee (FTE) QC Specialists and/or QC contractors, as needed. Competencies: Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information. Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others. Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events. Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others. Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget.