Senior Manager, Clinical Medical Writer
Bristol-Myers Squibb
Senior Manager, Clinical Medical Writer
Job Description
Medical Writing (70%) Author, edit, QC, and publish high-quality clinical and regulatory documents in accordance with ICH, GCP, and company standards including: Clinical Study Protocols and Amendments Informed Consent Forms (ICFs) Investigator Brochures (IBs) Clinical Study Reports (CSRs) Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents) Patient narratives and safety summaries Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides. Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders. Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations and other departments) for source data, input, and review. Manage outsourcing partners and medical writing consultants, when applicable. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Advanced degree (PhD, PharmD, MD, or Master's in Life Sciences or related field) preferred. Minimum of 3years of experience in clinical medical writing within the pharmaceutical, biotech, or CRO industry. At least 2 years of experience managing medical writing projects or acting in a lead writer role. Experience with oncology products required and radiopharmaceuticals a plus. Independent professional who proactively communicates frequently and effectively. Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making Solid understanding of the clinical drug development process and regulatory requirements for global submissions, including familiarity with eCTD structure and submission process. Excellent written and verbal communication skills with strong attention to detail and scientific accuracy. Proficiency in Microsoft Office Suite, document management systems, and project tracking tools (e.g., MS Project, Smartsheet, Veeva). Ability to manage multiple priorities in a matrixed environment with minimal supervision.
Key Responsibilities
- Author, edit, QC, and publish high-quality clinical and regulatory documents including Clinical Study Protocols and Amendments, Informed Consent Forms (ICFs), Investigator Brochures (IBs), Clinical Study Reports (CSRs), Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents), Patient narratives and safety summaries
- Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides
- Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders
- Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations and other departments) for source data, input, and review
- Manage outsourcing partners and medical writing consultants, when applicable
Required Qualifications
- Advanced degree (PhD, PharmD, MD, or Master's in Life Sciences or related field) preferred
- Minimum of 3 years of experience in clinical medical writing within the pharmaceutical, biotech, or CRO industry
- At least 2 years of experience managing medical writing projects or acting in a lead writer role
- Experience with oncology products required
Preferred Qualifications
- Experience with radiopharmaceuticals
Skills Required
- Independent professional who proactively communicates frequently and effectively
- Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making
- Solid understanding of the clinical drug development process and regulatory requirements for global submissions, including familiarity with eCTD structure and submission process
- Excellent written and verbal communication skills with strong attention to detail and scientific accuracy
- Proficiency in Microsoft Office Suite, document management systems, and project tracking tools (e.g., MS Project, Smartsheet, Veeva)
- Ability to manage multiple priorities in a matrixed environment with minimal supervision
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- San Diego RayzeBio, Canada
Salary
Estimated Salary Rangemedium confidence
100,000 - 150,000 CAD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Independent professional who proactively communicates frequently and effectivelyintermediate
- Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision makingintermediate
- Solid understanding of the clinical drug development process and regulatory requirements for global submissions, including familiarity with eCTD structure and submission processintermediate
- Excellent written and verbal communication skills with strong attention to detail and scientific accuracyintermediate
- Proficiency in Microsoft Office Suite, document management systems, and project tracking tools (e.g., MS Project, Smartsheet, Veeva)intermediate
- Ability to manage multiple priorities in a matrixed environment with minimal supervisionintermediate
Required Qualifications
- Advanced degree (PhD, PharmD, MD, or Master's in Life Sciences or related field) preferred (experience)
- Minimum of 3 years of experience in clinical medical writing within the pharmaceutical, biotech, or CRO industry (experience)
- At least 2 years of experience managing medical writing projects or acting in a lead writer role (experience)
- Experience with oncology products required (experience)
Preferred Qualifications
- Experience with radiopharmaceuticals (experience)
Responsibilities
- Author, edit, QC, and publish high-quality clinical and regulatory documents including Clinical Study Protocols and Amendments, Informed Consent Forms (ICFs), Investigator Brochures (IBs), Clinical Study Reports (CSRs), Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents), Patient narratives and safety summaries
- Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides
- Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders
- Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations and other departments) for source data, input, and review
- Manage outsourcing partners and medical writing consultants, when applicable
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Senior Manager, Clinical Medical Writer
Bristol-Myers Squibb
Senior Manager, Clinical Medical Writer
Job Description
Medical Writing (70%) Author, edit, QC, and publish high-quality clinical and regulatory documents in accordance with ICH, GCP, and company standards including: Clinical Study Protocols and Amendments Informed Consent Forms (ICFs) Investigator Brochures (IBs) Clinical Study Reports (CSRs) Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents) Patient narratives and safety summaries Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides. Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders. Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations and other departments) for source data, input, and review. Manage outsourcing partners and medical writing consultants, when applicable. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Advanced degree (PhD, PharmD, MD, or Master's in Life Sciences or related field) preferred. Minimum of 3years of experience in clinical medical writing within the pharmaceutical, biotech, or CRO industry. At least 2 years of experience managing medical writing projects or acting in a lead writer role. Experience with oncology products required and radiopharmaceuticals a plus. Independent professional who proactively communicates frequently and effectively. Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making Solid understanding of the clinical drug development process and regulatory requirements for global submissions, including familiarity with eCTD structure and submission process. Excellent written and verbal communication skills with strong attention to detail and scientific accuracy. Proficiency in Microsoft Office Suite, document management systems, and project tracking tools (e.g., MS Project, Smartsheet, Veeva). Ability to manage multiple priorities in a matrixed environment with minimal supervision.
Key Responsibilities
- Author, edit, QC, and publish high-quality clinical and regulatory documents including Clinical Study Protocols and Amendments, Informed Consent Forms (ICFs), Investigator Brochures (IBs), Clinical Study Reports (CSRs), Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents), Patient narratives and safety summaries
- Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides
- Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders
- Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations and other departments) for source data, input, and review
- Manage outsourcing partners and medical writing consultants, when applicable
Required Qualifications
- Advanced degree (PhD, PharmD, MD, or Master's in Life Sciences or related field) preferred
- Minimum of 3 years of experience in clinical medical writing within the pharmaceutical, biotech, or CRO industry
- At least 2 years of experience managing medical writing projects or acting in a lead writer role
- Experience with oncology products required
Preferred Qualifications
- Experience with radiopharmaceuticals
Skills Required
- Independent professional who proactively communicates frequently and effectively
- Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making
- Solid understanding of the clinical drug development process and regulatory requirements for global submissions, including familiarity with eCTD structure and submission process
- Excellent written and verbal communication skills with strong attention to detail and scientific accuracy
- Proficiency in Microsoft Office Suite, document management systems, and project tracking tools (e.g., MS Project, Smartsheet, Veeva)
- Ability to manage multiple priorities in a matrixed environment with minimal supervision
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- San Diego RayzeBio, Canada
Salary
Estimated Salary Rangemedium confidence
100,000 - 150,000 CAD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Independent professional who proactively communicates frequently and effectivelyintermediate
- Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision makingintermediate
- Solid understanding of the clinical drug development process and regulatory requirements for global submissions, including familiarity with eCTD structure and submission processintermediate
- Excellent written and verbal communication skills with strong attention to detail and scientific accuracyintermediate
- Proficiency in Microsoft Office Suite, document management systems, and project tracking tools (e.g., MS Project, Smartsheet, Veeva)intermediate
- Ability to manage multiple priorities in a matrixed environment with minimal supervisionintermediate
Required Qualifications
- Advanced degree (PhD, PharmD, MD, or Master's in Life Sciences or related field) preferred (experience)
- Minimum of 3 years of experience in clinical medical writing within the pharmaceutical, biotech, or CRO industry (experience)
- At least 2 years of experience managing medical writing projects or acting in a lead writer role (experience)
- Experience with oncology products required (experience)
Preferred Qualifications
- Experience with radiopharmaceuticals (experience)
Responsibilities
- Author, edit, QC, and publish high-quality clinical and regulatory documents including Clinical Study Protocols and Amendments, Informed Consent Forms (ICFs), Investigator Brochures (IBs), Clinical Study Reports (CSRs), Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents), Patient narratives and safety summaries
- Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides
- Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders
- Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations and other departments) for source data, input, and review
- Manage outsourcing partners and medical writing consultants, when applicable
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Senior Manager, Clinical Medical Writer @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs