Senior Manager Medical Writing Operations
Senior Manager Medical Writing Operations
Posted on :
20-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-01-2025
Job Description
Job Title: Senior Manager Medical Writing Operations
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
About Apogee Therapeutics
Founded in 2022 Apogee Therapeutics Inc. (Ticker: APGE) is a wellfunded Nasdaq listed company that offers the opportunity to work in a fastpaced highly dynamic environment. At Apogee you can actively contribute to shaping the company culture take on various roles and responsibilities and grow professionally.
Apogee Therapeutics Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting wellestablished mechanisms of action and incorporating advanced antibody engineering to optimize halflife and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment and we refuse to stop at “good enough.”
We are a fastpaced company committed to building an exceptional company culture founded on our C.O.R.E. values: Caring Original Resilient and Egoless.
If this sounds like you keep reading!
Role Summary
We are seeking a Senior Manager Medical Writing Operations to be responsible for creating and managing documents for global clinical trial disclosure and data transparency activities per applicable laws regulations and policies and will also have authoring and oversight responsibilities related to documents and processes that are in scope for the Medical Writing department. This role will serve as a subject matter expert and primary point of contact for transparency and disclosure activities (eg clinical trial results postings document redactions and plain language summaries) and will partner with team members in relevant functional areas and manage vendors who are directly involved in activities related to Medical Writing. The successful candidate must be flexible detailedoriented selfdirected and must manage workload to meet submission timelines across all company programs.
Key Responsibilities
What We Offer
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex gender identity sexual orientation race color religion national origin disability protected Veteran status age or any other characteristic protected by law.
To review our privacy policy click here
Founded in 2022 Apogee Therapeutics Inc. (Ticker: APGE) is a wellfunded Nasdaq listed company that offers the opportunity to work in a fastpaced highly dynamic environment. At Apogee you can actively contribute to shaping the company culture take on various roles and responsibilities and grow professionally.
Apogee Therapeutics Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting wellestablished mechanisms of action and incorporating advanced antibody engineering to optimize halflife and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment and we refuse to stop at “good enough.”
We are a fastpaced company committed to building an exceptional company culture founded on our C.O.R.E. values: Caring Original Resilient and Egoless.
If this sounds like you keep reading!
Role Summary
We are seeking a Senior Manager Medical Writing Operations to be responsible for creating and managing documents for global clinical trial disclosure and data transparency activities per applicable laws regulations and policies and will also have authoring and oversight responsibilities related to documents and processes that are in scope for the Medical Writing department. This role will serve as a subject matter expert and primary point of contact for transparency and disclosure activities (eg clinical trial results postings document redactions and plain language summaries) and will partner with team members in relevant functional areas and manage vendors who are directly involved in activities related to Medical Writing. The successful candidate must be flexible detailedoriented selfdirected and must manage workload to meet submission timelines across all company programs.
Key Responsibilities
- Contribute to the development of global clinical trials transparency and disclosure strategy objectives capabilities and policy
- Lead teams in the preparation and maintenance of CCI and PPD rules across programs ensuring consistency of publicly disclosed information across countries registries databases and documents
- Manage the preparation of plain language summaries and redaction of clinical documents in accordance with regional and global regulations
- Stay current on evolving requirements related to clinical trials transparency and disclosure and ensure organizational compliance
- Prepare review and edit highquality scientifically accurate and submissionready documents including but not limited to study protocols investigator’s brochures and clinical study reports
- Negotiate with functional areas regarding deliverables and timelines to meet conflicting demands removing barriers and using creativity to ensure teams achieve documentrelated project goals
- Oversee the planning and coordination of Medical Writing projects by external vendors to ensure milestones are met
- Develop and/or maintain regulatory style guide and Medical Writingrelated SOPs templates work instructions and user guides to ensure consistency and quality in written materials
- Bachelor’s degree in science (advanced degree is a plus)
- Must have a minimum of 4 years of experience as a regulatory or medical writer with at least 2 years of global clinical trials transparency/disclosure process and strategy experience in the biotechnology or pharmaceutical setting
- Selfstarter with strong planning organizational and project management skills along with initiative and ability to be productive independently
- Outstanding interpersonal and communication skills with experience interacting with and influencing people and building strong positive relationships
- Ability to evaluate and recommend process improvements and suggest/implement best practices
- Proven ability to adapt to change and uncertainty as projects evolve or shift and to multitask and adjust priorities quickly while working under tight deadlines
What We Offer
- A great culture grounded in our C.O.R.E. values: Caring Original Resilient and Egoless
- Opportunity to work in a fastpaced highly dynamic environment where you help shape the culture and company wear multiple hats and learn quickly
- Market competitive compensation and benefits package including base salary performance bonus equity grant opportunities health welfare & retirement benefits
- Flexible PTO
- Two oneweek companywide shutdowns each year
- Commitment to growing you professionally and providing access to resources to further your development
- Apogee offers regular all team inperson meetings to build relationships and problem solve
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex gender identity sexual orientation race color religion national origin disability protected Veteran status age or any other characteristic protected by law.
To review our privacy policy click here
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Employment Type
Full Time
Key Skills
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