更新于 12月31日

Medical Writer Manager

面議
  • 北京東城區(qū)
  • 5-10年
  • 本科
  • 全職
  • 招1人

職位描述

眼科CER
OBJECTIVES/PURPOSE OF JOB:
Takes responsibilities for China CER (clinical evaluation report) drafting, monitoring worldwide on-going clinical trial progress to support China CER strategy, support to potential CER in Japan, medical letters to other markets in APAC. Participates in relevant key projects technical/clinical discussion. Interacts extensively with internal clinical and medical leadership and manages all aspects of external CER vendors’ relationships.

KEY ACTIVITIES/RESPONSIBILITIES:
? Works collaboratively with Regulatory Affairs (RA), Clinical Development (CD) and Medical Affairs (MA) to evaluate/provide strategic clinical evaluation approach for product new registration (or variation registration if clinical evaluation required) to avoid or minimize a repetitive clinical trial.
? Works with internal RA/Marketing/MA/Clinical experts to train CER vendor on product attributes (if necessary) before CER drafting.
? Collaborates with internal (clinical development department, RA project owners, study managers, statisticians, business peers, post-market surveillance, etc.) and external (CER vendors, clinical consultants, subject matter experts, regulatory agencies) partners to ensure comprehensive analysis of clinical evidence.
? Works as product introduction presenter during CER vendor bidding process.
? Works effectively with internal and external partners to develop high-quality clinical evaluation report under aligned timeline.
? Reviews and approves CER documentations.
? Ensures appropriate evaluation and presentation of the data, methodology and interpretation.
? Support clinical development expert and RA to answer Health Authority questions during filling review and technical review process of product registration.
? Reviews, assesses and revises relevant procedures and SOPs regarding efficiency, workflow and implementation.
? Performs other duties as assigned.

EDUCATION:
Master’ or bachelor’ degree preferred in Ophthalmology Science or Biomedical Science field or Science

EXPERIENCE/ COMPETENCIES:
Preferably 5+ years of experience in managing or drafting role in medical device, at least 1 year of hands-on CER drafting experience.

工作地點(diǎn)

北京

職位發(fā)布者

bauschchina/人事經(jīng)理

昨日活躍
立即溝通
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博士倫公司博士倫是一家專門致力于保護(hù)并改善全世界數(shù)以百萬計(jì)人們的視力的公司,它關(guān)照人們從出生到生命的各個(gè)階段。我們的愿景簡單卻有力:幫助您實(shí)現(xiàn)清晰視覺,睛彩人生。博士倫是全世界范圍內(nèi)享有盛譽(yù),倍受尊重的醫(yī)藥保健品牌之一,我們提供包括隱形眼鏡,鏡片護(hù)理產(chǎn)品,眼科藥品,眼內(nèi)鏡片以及其他眼睛外科手術(shù)產(chǎn)品在內(nèi)的最廣泛,最優(yōu)良的眼睛保健產(chǎn)品系列。我們最優(yōu)先考慮的是所服務(wù)的人們的健康和福利。通過對(duì)顧客和病患的傾聽,持續(xù)改進(jìn)我們的創(chuàng)新能力,正直而卓越地執(zhí)行,努力贏得合作伙伴和利益相關(guān)人的信任。在過去的150年里,博士倫已經(jīng)成為全球范圍內(nèi)創(chuàng)新和品質(zhì)的代名詞。我們富有天賦和動(dòng)力的同事們不辭辛勞地研發(fā)新材料,創(chuàng)造新技術(shù),最終利用新發(fā)明幫助人們實(shí)現(xiàn)清晰視覺,睛彩人生。博士倫中國博士倫在中國有三家獨(dú)立運(yùn)行的公司和兩家工廠,分別是北京博士倫眼睛護(hù)理產(chǎn)品有限公司,博士倫(上海)貿(mào)易有限公司和山東博士倫福瑞達(dá)制藥有限公司,工廠分別位于山東濟(jì)南和北京。北京博士倫眼睛護(hù)理產(chǎn)品有限公司,建立于1988。主要生產(chǎn)和銷售代表世界先進(jìn)水平的眼睛護(hù)理產(chǎn)品,包括透明鏡片,彩色鏡片,護(hù)理產(chǎn)品等,實(shí)現(xiàn)產(chǎn)品的全面覆蓋。公司采用美國博士倫先進(jìn)的產(chǎn)品技術(shù)和制造工藝,是行業(yè)首家通過方圓及德國TUF公司ISO9002國際質(zhì)量認(rèn)證的眼睛護(hù)理產(chǎn)品制造和銷售企業(yè),和中國首家通過ISO醫(yī)療器械質(zhì)量體系認(rèn)證的隱形眼鏡制造和銷售商。博士倫(上海)貿(mào)易有限公司,主要經(jīng)營博士倫眼科手術(shù)產(chǎn)品。博士倫眼科手術(shù)產(chǎn)品是博士倫大家庭中最重要的成員之一,代表了博士倫立足于發(fā)展眼科高科技的企業(yè)形象。博士倫眼科手術(shù)產(chǎn)品主要包括白內(nèi)障、玻璃體視網(wǎng)膜手術(shù)設(shè)備、人工晶體、相關(guān)耗材和手術(shù)器械等,種類齊全,技術(shù)先進(jìn),設(shè)計(jì)合理,質(zhì)量優(yōu)良,多年來在國際眼科界得到廣泛應(yīng)用,使全世界無數(shù)的眼疾患者重新恢復(fù)了光明。山東博士倫福瑞達(dá)制藥有限公司,由美國博士倫公司于2005年投資山東正大福瑞達(dá)制藥有限公司成立。山東正大福瑞達(dá)制藥有限公司成立于1991年,是由山東福瑞達(dá)醫(yī)藥集團(tuán)公司、泰國正大制藥集團(tuán)和美國福瑞達(dá)國際有限公司共同投資組建的中外合資企業(yè)。致力于生物技術(shù)產(chǎn)品和生化藥品的研究開發(fā)、生產(chǎn)和銷售。
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