Document Review Specialist (Level II)
Pharmaceutical Product Development (PPD)
Cambridge, GB, GB
3d ago

PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people.

We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

For our growing Global Medical Writing team, we are look for an experienced professional to join PPD as a : Document Review Specialist (Level II) The Document Review Specialist is responsible for the thorough review of documents created within or outside of PPD in order to ensure quality of a standard that meets or exceeds client's expectations.

These documents include, but are not limited to, regulatory submissions (sections of NDAs, BLAs, PLAs, INDs, CTDs), integrated clinical study reports, serious adverse event narratives, study protocols, and publications (manuscripts, posters, abstracts).

The Document Review Specialist is responsible for ensuring the integrity of the data presented by conducting a timely and cost-effective review of diverse scope against client, PPD, and regulatory requirements and specifications.

The Document Review Specialist brings to the review knowledge of clinical research, PPD procedures, English grammar, medicine, experimental design, and regulatory requirements.

PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people.

We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

For our growing Global Medical Writing team, we are look for an experienced professional to join PPD as a : Document Review Specialist (Level II) The Document Review Specialist is responsible for the thorough review of documents created within or outside of PPD in order to ensure quality of a standard that meets or exceeds client's expectations.

These documents include, but are not limited to, regulatory submissions (sections of NDAs, BLAs, PLAs, INDs, CTDs), integrated clinical study reports, serious adverse event narratives, study protocols, and publications (manuscripts, posters, abstracts).

The Document Review Specialist is responsible for ensuring the integrity of the data presented by conducting a timely and cost-effective review of diverse scope against client, PPD, and regulatory requirements and specifications.

The Document Review Specialist brings to the review knowledge of clinical research, PPD procedures, English grammar, medicine, experimental design, and regulatory requirements.

Education and Experience :

Bachelor's degree

4 years of relevant experience including 1 year of experience within the pharmaceutical / medical device industry and 2 years of writing, clinical research, and editing experienceOr equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities

Knowledge, Skills and Abilities : Excellent analytical ability Excellent working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies Knowledge of medical, pharmaceutical, and clinical research conceptsExcellent problem-solving capabilities and organizational skills and effective interpersonal skills Possess excellent grammatical and exceptional communication skills, both written and oral Excellent editorial / proofreading skills and will understand and perform well the process of writing, reviewing, and editing Extensive knowledge of the methods, techniques, and procedures of medical writing tasks.

Must be detail-oriented, thorough, and methodicalAdaptable to changes in work duties, responsibilities, and requirements Appropriately apply judgment to making changes Ability to concentrate on the detail in a document without losing sight of the document as a whole and can perform numerous simple and complex tasks without ignoring the overall objectives Proficient with software packages including, but not limited to : Microsoft Word, WordPerfect, and Microsoft Excel Ability to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.

We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

We are a global organisation but with a local feel.

  • We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
  • If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application we’d love to hear from you.

    Education and Experience :

    Bachelor's degree

    4 years of relevant experience including 1 year of experience within the pharmaceutical / medical device industry and 2 years of writing, clinical research, and editing experienceOr equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities

    Knowledge, Skills and Abilities : Excellent analytical ability Excellent working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies Knowledge of medical, pharmaceutical, and clinical research conceptsExcellent problem-solving capabilities and organizational skills and effective interpersonal skills Possess excellent grammatical and exceptional communication skills, both written and oral Excellent editorial / proofreading skills and will understand and perform well the process of writing, reviewing, and editing Extensive knowledge of the methods, techniques, and procedures of medical writing tasks.

    Must be detail-oriented, thorough, and methodicalAdaptable to changes in work duties, responsibilities, and requirements Appropriately apply judgment to making changes Ability to concentrate on the detail in a document without losing sight of the document as a whole and can perform numerous simple and complex tasks without ignoring the overall objectives Proficient with software packages including, but not limited to : Microsoft Word, WordPerfect, and Microsoft Excel Ability to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results

    At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

    As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.

    We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

    We are a global organisation but with a local feel.

  • We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
  • If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application we’d love to hear from you.

    2021-03-30 00 : 00 : 00

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