Description

Position Summary: The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following: • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts • Participates in scientific communication planning, including development of strategic medical communication plans • Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources. • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes • Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents • Manages the document review process ensuring conflicting and/or ambiguous comments are 2 Medical Writer Revised 01/2018 clarified and appropriately addressed • Works closely with the study team to reach consensus on timelines for deliverables • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations • Manages all aspects of outsourced or internal CSR production and ensures project delivery • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines • Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables • Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity • Align with department management to set strategy for meeting department goals Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the experience, knowledge, skill, and/or ability required. Education/Experience: The ideal candidate will offer: • At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred. • Bachelors degree +8 years, Master’s Degree +5 years, Doctoral Degree +2 years of relevant medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas; graduate degree (master’s or doctoral) preferred • An understanding of the drug development process • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages • Experience in interacting with cross functional study team members Knowledge, Skills and Abilities: • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately. • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members Interested candidates can share their profiles on [email protected]

Role and Responsibilities

• Position Summary: The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following: • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts • Participates in scientific communication planning, including development of strategic medical communication plans • Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources. • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes • Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents • Manages the document review process ensuring conflicting and/or ambiguous comments are 2 Medical Writer Revised 01/2018 clarified and appropriately addressed • Works closely with the study team to reach consensus on timelines for deliverables • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations • Manages all aspects of outsourced or internal CSR production and ensures project delivery • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines • Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables • Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity • Align with department management to set strategy for meeting department goals Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the experience, knowledge, skill, and/or ability required. Education/Experience: The ideal candidate will offer: • At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred. • Bachelors degree +8 years, Master’s Degree +5 years, Doctoral Degree +2 years of relevant medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas; graduate degree (master’s or doctoral) preferred • An understanding of the drug development process • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages • Experience in interacting with cross functional study team members Knowledge, Skills and Abilities: • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately. • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members Interested candidates can share their profiles on [email protected]