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Senior Quality Control (QC) Specialist

Company: BeiGene
Location: Ridgefield Park
Posted on: June 5, 2021

Job Description:

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 (QC) Specialist 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.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 documentsResponsible for performing a quality check of clinical regulatory documents before approvalProofread documents for grammatical errors, formatting errors, hyperlink functionality, data source verification, and proper translation of dataPerform cross-referencing, fact-checking, and general quality assessments of documentsManage timelines and communicate with Medical Writers to maintain awareness of expectations, milestones, and deliverablesReview and edit documents written within BeiGene, as well as those authored externallyEnsure compliance with Medical Writing conventions, processes, and applicable regulatory guidelinesQualifications:Knowledge and SkillsDemonstrated ability to communicate in clear, concise, and effective English in both written and verbal formsStrong project management skills: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demandsMaintain consistent attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing high volume, repetitive tasksIndependently motivated with good problem-solving abilityExcellent interpersonal skills; a team playerExtensive 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 plusA thorough understanding of the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelinesWorking knowledge of the development of drugs and biologics (ie, clinical study design, biostatistics, regulatory affairs, and medical terminology) preferredAbility to ensure reviewed documents comply with company and/or industry style guides and templatesComputer SkillsTechnical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerpointEducation RequiredAt a minimum, a BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plusAt least 3-5 years of relevant industry experience as a QC editor/specialist, medical writer or copyeditorSupervisoryResponsibilities: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 munication - 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.We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.Full timeSDL2017

Keywords: BeiGene, Tenafly , Senior Quality Control (QC) Specialist, Other , Ridgefield Park, New Jersey

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